+ All Categories
Home > Documents > lVorrml1 OF...Patients: Women undergoing operative hysteroscopy in an office setting, Interventions:...

lVorrml1 OF...Patients: Women undergoing operative hysteroscopy in an office setting, Interventions:...

Date post: 28-Jul-2020
Category:
Upload: others
View: 5 times
Download: 0 times
Share this document with a friend
8
THE JOURNAL OF MINIMALLY It; .".! GYNECOLOGY ELSEVIER Original Article Operative Hysteroscopy in an Office-Based Surgical Setting: Review of Patient Safety and Satisfaction in 414 Cases Morris Wortman, MD*, Amy Daggett, RN, ANP, and Courtney Ball, RN From th e Center jor Menstrual Disorders and Reproductive Choice, UniversifY of Rochester Medical Center, RochesTer, New York (all authors). ABSTRACT Study Objective: To determine the safety and satisfaction among patients undergoing operative hysteroscopy in an o ff... based setting, Design: Retrospective analysis (Canadian Task Force classification II-2). Setting: Physician's private office, Patients: Women undergoing operative hysteroscopy in an office setting, Interventions: Three hundred eighty-seven women underwent a total of 414 operative hysteroscopic procedures, with parenterally administered moderate sedation, a 9-mm operative resectoscope, and sonographic guidance, All patients American Society of Anesthesiologists class I-III. Measurements and Main Results: A total of 305 primary operative hysteroscopic procedures were performed includi ng. domyometrial resection, myomectomy, polypectomy, removal of a uterine septum, and adhesioIysis. One hundred II: (26,3%) repeat operative procedures were perfOImed in women in whom previous endometrial ablation and resection failed, The average procedure required a mean (SD) of37,6 (13,5) minutes to complete, and produced 14. 1 (10,2) g of tis. Ninety-nine percent of all procedures were completed. Only 1 patient required a hospital transfer for evaluation of a UI cr11 perforation necessitating diagnostic laparoscopy. There were 8 (1.9%) postoperative infections, and no complications all ri able to use of conscious sedation. Two hundred fifty-five women (65.6%) responded to our telephone survey. Two hum . fifty-two (98.8%) respondents were either "very satisfied" or "satisfied." Two hundred forty-nine women (97,6%) prefe the office to a hospital setting, whereas 6 (2.4%) would have preferred a hospital setting. All but 5 respondents would r mend this procedure to a friend. Conclusion: Major operative hysteroscopic surgery can be performed in an office-based setting with a high degree safety and patient satisfaction. Journal of Minimally Invasive Gynecology (2013) 20, 56--63 Published by Elsevier In . behalf of AAGL Keywords: Endomyometrial resection; Hysteroscopic; Moderate sedation; Myomectomy; Office-based surgery; Sonographic guidance DISCUSS You can discuss this article with its authors and with other AAGL members at http://www.AAGL.org/jmig-20-1-12-00343 "0 ,0"' S."'" to scan thi s QR , r and connect to !lit- discussion fo romilr this article no \\ ' L!J . Operative hysteroscopy encompasses an important set of skills in the gynecologic armamentarium for the treatment of infertility, pregnancy loss, and abnormal uterine bleeding. The authors have no commercial , proprietary, or financial interest in the products or companies described in this article, Corresponding author: Morris Wortman, MD, University of Rochester Med- ical Center, Center for Menstrual Disorders and Reproductive Choice, 2020 S Clinton Ave, Rochester, NY 14618. E-mail: [email protected] Submitted July 10, 2012, Accepted for publication August 23, 2012, Available at www.sciencedirecLcom and www.jmig.org 1553-4650/$ - see front matter Published by Elsevier Inc. on behalf of AAGL. http://dx.doi.org/10,1016/j.jmig,2012,08.778 DQ..... nlo. 'ld <l free QR CO(k s(':'lIlm:r R i n )'uo r app •• ure l'f "t9 The introduction of small-diameter operative hysteroscojli has enabled a few skilled and motivated surgeons to perf o r' operative hysteroscopy in an office-based surgical (OBS setting. The advantages of operative hysteroscopy inc lu the possibility to diagnose and treat lesions in a session and the convenience and efficiency for both tlr physician and patient. An additional benefit of office·baxt. operative hysteroscopy has been suggested by Lindhe et al [I], who more than a decade ago, noted the cost sa vilt per case of at least 50% when compared with the equivalent. In western New York State, we estimate cost to the insurance companies for an average operali\
Transcript
Page 1: lVorrml1 OF...Patients: Women undergoing operative hysteroscopy in an office setting, Interventions: Three hundred eighty-seven women underwent a total of 414 operative hysteroscopic

THE JOURNAL OF

MINIMALLY It GYNECOLOGY

ELSEVIER

Original Article

Operative Hysteroscopy in an Office-Based Surgical Setting Review of Patient Safety and Satisfaction in 414 Cases

Morris Wortman MD Amy Daggett RN ANP and Courtney Ball RN From the Center jor Menstrual Disorders and Reproductive Choice UniversifY of Rochester Medical Center RochesTer New York (all authors)

lVorrm l1

hyster servelt

In who Ul

cervic scope

In = wornel cludin which along point l proced a wide

ABSTRACT Study Objective To determine the safety and satisfaction among patients undergoing operative hysteroscopy in an off based setting Design Retrospective analysis (Canadian Task Force classification II-2) Setting Physicians private office Patients Women undergoing operative hysteroscopy in an office setting Interventions Three hundred eighty-seven women underwent a total of 414 operative hysteroscopic procedures with ulaquo parenterally administered moderate sedation a 9-mm operative resectoscope and sonographic guidance All patients ~

American Society of Anesthesiologists class I-III Measurements and Main Results A total of 305 primary operative hysteroscopic procedures were performed includi ng domyometrial resection myomectomy polypectomy removal of a uterine septum and adhesioIysis One hundred II (263) repeat operative procedures were perfOImed in women in whom previous endometrial ablation and resection failed The average procedure required a mean (SD) of376 (135) minutes to complete and produced 141 (102) g of tis Ninety-nine percent of all procedures were completed Only 1 patient required a hospital transfer for evaluation of a UIcr11

perforation necessitating diagnostic laparoscopy There were 8 (19) postoperative infections and no complications allri able to use of conscious sedation Two hundred fifty-five women (65 6) responded to our telephone survey Two hum fifty-two (988) respondents were either very satisfied or satisfied Two hundred forty-nine women (976) prefe the office to a hospital setting whereas 6 (24) would have preferred a hospital setting All but 5 respondents would r mend this procedure to a friend Conclusion Major operative hysteroscopic surgery can be performed in an office-based setting with a high degree safety and patient satisfaction Journal of Minimally Invasive Gynecology (2013) 20 56--63 Published by Elsevier In behalf of AAGL

Keywords Endomyometrial resection Hysteroscopic Moderate sedation Myomectomy Office-based surgery Sonographic guidance

DISCUSS You can discuss this article with its authors and with other AAGL members at httpwwwAAGLorgjmig-20-1-12-00343

bull 0 0 S to scan this QR r and connect to litshybull discussion fo romilr ~ bull this article no LJ

same y of 42 v an OB tern an

In L hysterc ter ope dures polyps pedirne nigue patient ing rerr rience

To ( an OB~ ( 5 rr parente the firs a full-s larger achieve enable( procedl satisfac

Operative hysteroscopy encompasses an important set of skills in the gynecologic armamentarium for the treatment of infertility pregnancy loss and abnormal uterine bleeding

The authors have no commercial proprietary or financial interest in the products or companies described in this article Corresponding author Morris Wortman MD University of Rochester Medshyical Center Center for Menstrual Disorders and Reproductive Choice 2020 S Clinton Ave Rochester NY 14618 E-mail moe2020cmdrccom

Submitted July 10 2012 Accepted for publication August 23 2012 Available at wwwsciencedirecLcom and wwwjmigorg

1553-4650$ - see front matter Published by Elsevier Inc on behalf of AAGL http dxdoiorg101016jjmig201208778

bull DQnlold ltl free QR CO(k oCJn lluby~1laquo s(lIlmrR in )uo r )lIrunphor~middot app bullbull ure lf t9

The introduction of small-diameter operative hysteroscojli has enabled a few skilled and motivated surgeons to perfor operative hysteroscopy in an office-based surgical (OBS setting The advantages of operative hysteroscopy inclu the possibility to diagnose and treat lesions in a ~i ng

session and the convenience and efficiency for both tlr physician and patient An additional benefit of officemiddotbaxt operative hysteroscopy has been suggested by Lindhe et al [I] who more than a decade ago noted the cost savilt per case of at least 50 when compared with the ho~pil1

equivalent In western New York State we estimate cost to the insurance companies for an average operali

Materi

Thn 4140pl of a r continu include polypel toscopi rnyome geomet trium i 5 mm uterus gion 1 posed I

57 NAL O F

LLY INVASIVE TECOLOGY

eview

IOrI)

py in an office-

res with use of II patients were

ed including enshye hundred nine d resection had 102) g of tissue tion of a uterine ications attri butshyy Two hundred 76) preferred Is would recomshy

high degree of Elsevie[ Inc on

ce

your Smart phone can Thi s QR code connect 10 the ussion forum for article now

rlt- t-y ~ r1l1 nG for -OR pp (tore orapp markdplac

hY teroscopes s to pelform

rgical (OBS) include

of office-based by Lindheim

the cost saving ith the hospital

estimate the operative

II gtIIman el af Officemiddotbased Hysteroscopic Surgery

fysteroscopy in an OBS setting to be in the same range obshyrved by Lindheim and colleagues

In 1996 Porreca et al [2] reported a series of 253 women I ho underwent hysteroscopic treatment of endometrial and cervical polyps with 5F instruments and an office hysteroshyope with operative sheath

In 2000 Lindheim et al [1] reported a series of 33 inferti Ie women who underwent various hysteroscopic procedures inshyluding polypectomy myomectomy and adhesiolysis in hich small-diameter hysteroscopes ( 4 mm) were used liang with either mechanical scissors or a Gynecare Versashypoint bipolar electrode (Ethicon Inc Somerville NJ) All orocedures were performed in an OBS setting using

wide variety of analgesic and anesthetic regimens That meyear Sesti et al [3] reported excellent results in a series of 42 women who underwent hysteroscopic polypectomy in ill OBS setting using the Gynecare Versapoint bipolar sysshymand local anesthesia

In 2004 Bettocchi et al [4] reported on 4863 operative h teroscopic procedures performed using a 5 0-mm diameshyer operative hysteroscope and 5F instruments The proceshyiJres included the removal of cervical and endometrial lllyps along with adhesiolysis and repair of anatomic imshyxdiments Bettocchi et al [4] used a vaginoscopic techshylique without analgesics or anesthesia and noted that plients reported little discomfort although those undergoshyngremoval of endometrial polyps were more likely to expeshy

rience moderate discomfort To date all of the reported operative hysteroscopies in

mOBS setting have been performed using small diameter 1 ~ 5 mm) instruments and with few exceptions without 1arenterally administered analgesia or sedation This is he first report of office-based hysteroscopic surgery using

fulI-size 26F (9 mm) operative resectoscope The use of arger instruments parenterally administered agents to lhieve moderate sedation [56] and ultrasound guidance Mbled us to safely perform complex and highly invasive ocedures with a high degree of safety and patient 1tisfaction

llalerials and Methods

Three hundred eighty-seven women underwent a total of 14 operative hysteroscopic procedures in the private office

a physician (MW) with use of a standard 9-mm ont inuous-flow gynecologic resectoscope Procedures nduded endomyometrial resection [7] myomectomy ~lypectomy and repeat surgery after failure of both resecshy

copic and nonresectoscopic endometrial ablation Endoshy)ometrial resection (Fig 1) is the systematic and

eometric approach for removing the entire endomyomeshyrium in long continuous strips of tissue to a depth of 4 to mm below the endometrial basalis in all portions of the (erus the depth is decreased to 2 to 3 mm in the cornual reshyion This is followed by the deep coagulation of the exshyXled myometrium using a ball-end electrode

Endomyomecrial resection

All patients underwent extensive screening including a complete history and physical examination transvaginal ultrasound and selected laboratory studies Formal counselshying included discussion of alternate treatment regimens and the potential for immediate and delayed complications associated with hysteroscopic surgery Most patients did not undergo diagnostic hysteroscopy before the operative procedure

All procedures were performed in a dedicated operating room located within an accredited OBS setting as required under New York State Public Health Law sect230-d [8] Patients above American Society of Anesthesiologists class III were excluded from undergoing a procedure in an OBS setting Numerous patients required formal medical clearance before the procedure and in women aged gt50 years an electrocarshydiogram was obtained within 30 days before the surgery

The operating room team consisted of 5 individuals including the surgeon (MW) a first assistant a trained soshynographer (AD) a fluid management specialist and a regisshytered nurse (CB) dedicated solely to monitoring the patient and administering intravenous analgesics and sedatives All operating room personnel were trained and credentialed in advanced cardiac life support crew resource management [9] and the use of moderate conscious sedation as well as procedure-specific training

In nearly all instances patients were seen the day before surgery for preoperative counseling peri operative instrucshytions and insertion of a 3-mm Iaminaria japonica In patients who requested tubal sterilization Adiana (Hologic Inc Bedford MA) procedures were performed at the time of laminaria insertion although several patients underwent Essure (Conceptus Inc Mountain View CA) sterilization procedures before hysteroscopic surgery Patients were inshyformed that hysterosalpingography would not be feasible as required by the manufacturers instructions for use Pashytients were asked to not eat solid food for a minimum of 4 hours before surgery but were allowed clear liquids until 2 hours before the scheduled operating room time

On the day of surgery an intravenous catheter and hepashyrin lock was placed in all patients and 2 g ampicillin was adshyministered intravenously several minutes before surgery

l

58 Journal of Minimally Invasive Gynecology Vol 20 No 1 January February 2013

Patients allergic to penicillin received either 500 mg metroshynidazole or 300 mg clindamycin intravenously Most pashytients also received 06 mg atropine intravenously just before surgery Patients with a history of narcotic-related nausea often received premedication with 125 to 25 mg promethazine intravenously

Before each procedure the patients maximum allowable fluid absorption (MAFA limit ) [10] was calculated In accorshydance with AAGL [11] guidelines no patient was allowed to absorb more than 1500 mL glycine 15 or 2500 mL norshymal saline solution Whenever the MAFA limir was calculated to be less than allowable according to AAGL guidelines the lesser of the 2 limits was imposed Whenever the MAFAimit exceeded the AAGL guidelines the lesser of the 2 restricshytions was employed

Most procedures were performed using a monopolar 26F (9 mm) continuous-flow resectoscope (Karl Storz Endosshycopy America Inc Culver City CA and Circon-ACMI dishyvision of Circon Corp Stamford CT) occasionally in the presence of marked cervical stenosis or a small postmenoshypausal uterus a 22F (7 mm) resectoscope was used either as the sole instrument or in combination with the larger reshysectoscope Glycine 15 was administered via either the Dolphin (Circon ACMI) or Hamou Endomat (Karl Storz Enshydoscopy America) fluid management system A small numshyber of procedures were performed using a 26F bipolar resectoscope (Karl Storz Endoscopy America) All proceshydures were performed under sonographic guidance using a 35-MHz abdominal transducer placed just above the symshyphysis pubis by one of us (AD)

Nearly all patients received an initial dose of25 to 50 mg midazolam and 50 to 100 Ilg fentanyl intravenously Addishytional doses were given only after a minimum elapsed intershyval of 3 minutes and included no more than 25 mg midazolam or 50 Jlg fentanyl Supplemental medication could include a sedative an opiate or a combination of both In the latter part of the study period during a nationshywide shortage of parenterally administered opiates and benshyzodiazepines nalbuphine hydrochloride and ketamine were used in conjunction with orally administered midazolam

Procedures commenced with removal of the laminaria jashyponica Dilation was performed using a Hegar dilator under sonographic guidance A total of 20 mL saline solution conshytaining 25 U vasopressin was injected intracervically at the 3-0clock and 9-0clock positions using a 21-gauge X IY2shyinch needle After insertion of a continuous-flow resectoshyscope operative procedures were generally initiated with pump pressure varying from 140 to 175 mm Hg and adjusted to balance satisfactory visualization with fluid intravasation The surgeon was apprised of fluid deficits in 50- to 100-mL increments A standard endomyometrial resection technique [7] with only slight modification [12] was used combined with resection of endometrial polyps and removal of submushycous and intramural leiomyomas as they were found All procedures were digitally recorded using a MediCapture USB200 device (MediCapture Inc Philadelphia PA)

Patients recovered in the operating room and were monishytored according to a standardized post-anesthesia recovery protocol described by Aldrete and Kroulik [13] Discharge criteria included a post-anesthesia recovery score (Fig 2) of 9 the ability to walk out of the office (ie without a wheelshychair) and vaginal bleeding lt 1 gmin The next day patients were contacted by one of us (AD or CB) via telephone

A simple patient satisfaction survey form was devised (Fig 3) and attempts were made to contact all patients who had undergone office-based hysteroscopic surgery from March 29 2007 to March 27 2012 The questionnaire was adshyministered as a telephone survey by one of us (AD or CB)

Results

A total of 414 office-based hysteroscopic procedures were performed in 387 patients The mean (SD 95 CI) age of the patients was 442 (69 43 5-449) years Three hundred five women (737) underwent primary proceshydures and the remaining 109 (263) underwent repeat operative procedures after failure of nonresectoscopic endoshymetrial ablation myomectomy or previous endomyometrial resection in procedures performed outside of the present study A summary of the procedures and their indications are given in Tables 1 and 2 respectively

Of the 305 women undergoing a primary hysteroscopic procedure 64 (210) were asked to undergo previous diagshynostic hysteroscopy to determine whether they were suitable candidates for surgery The remaining 79 underwent a sinshygle-stage diagnostic and operative procedure None of the patients requiring repeat surgery were asked to undergo dishyagnostic hysteroscopy Three hundred sixty-four women (87 9) underwent placement of a 3- or 4-mm laminaria japonica on the day before surgery

In 2007 a total of 6 procedures were attempted and comshypleted in our office representing 100 of the total pershyformed that year In 2008 18 procedures representing 27 3 of that years total were achieved in the OBS setting From January 12009 to March 272012 a total of390 proshycedures were performed at our facility representing 980 of the sum performed during those years Of the 8 proceshydures completed in the hospital during that period 1 was pershyformed in an otherwise healthy woman who requested a hospital-based setting and the remaining 7 in patients with medical contraindications to office-based surgery

Four hundred eleven of 414 procedures (993) were completed Three hundred ninety-two (947) were accomshyplished using a combination of parenterally administered midazolam and fentanyl Ninety-eight women (237) with a history of nausea and vomiting due to previously adshyministered anesthetics were premedicated using promethashyzine in doses varying from 125 to 25 mg Of the women receiving the midazolam-fentanyl combination the mean (SD 95 CI) dose required to accomplish the procedure was 1057 (35 1023-1091) mg midazolam and 2001 (885 1916-2086) Jlg fentanyl The duration of the

Wortmallel

Fig 2

Post-anes

procedUi from ad complet were co agent N acombi ing 3 (C

The flu i (421 4

Fig 3

Patient

PalitJ

HOW l

WOtl~

Wool

59 IFebruury 2013

iI(INmall et af Office-based Hysteroscopic Surgery

d were monishysia recovery J Discharge re (Fig 2) of hout a wheelshyt day patients telephone was devised patients who

surgery from nnaire was adshy

0 or CB)

ic procedures SO 95 el) years Three

imary proceshyerwent repeat oscopic endoshydomyometrial f the present ir indications

hysteroscopic previous diagshywere suitable

derwent a sinshy None of the to undergo dishy-four women

mm laminaria

pted and comshythe total pershy

representing e OBS setting tal of 390 proshy

riod I was pershyrequested

7 in patients

of the

Respirations Able to breath deeply and cough freely 2 Dyspnea or limited breathing 1 Apneic (no breathing) o

Circulation BP plusmn 20 of preanesthesia level 2 BP plusmn 21-49 of preanesthesia level 1 BP plusmn50 of preanesthesia level o

Level of consciousness Fully awake 2 Arousable on calling 1 Not responding o

Color Able to maintain oxygen saturationgt 92 on room air 2 Needs oxygen inhalation to maintain oxygen satgt 90 1 Oxygen saturation lt 90 even with oxygen supplement o

A patient MUST have a total score of 8 or higher to be discharged

Post-anesthesia recovery score

Motor

PAR Score [13]

Able to move four extremities voluntarily or on command 2 Able to move two extremities voluntarily or on command I Able to move no extremities voluntarily or on command o

procedure was 376 (135 36 3-38 9) minutes as calculated irom administration of the first dose of midazolam until ompletion Three hundred ninety-two procedures (947) rae completed using glycine 15 as the sole distention gent Nineteen procedures (46) were accomplished using combination of glycine and saline solution and the remainshyng 3 (07) were performed using saline solution alone The fluid deficit of the patients receiving glycine was 461 ni 4204-5016) mL The 22 women who received nor-

Patient satisfaction survey questionnaire

Questionnaire

Palient salisfaclion

How siu i reoare you wi th your procedure _ Very satisfied

Sawtied _ Some what di-satisfied _ Very dis~iltl ti s fied

Would you rClonuncnd this procedure [0 il friend Yes

_No

Would you hilve preferred to have had your procedure pcrformcd in a hoSpital Yes

_No

mal saline solution absorbed 758 (448 5708-9452) mL There were no instances of excess fluid absorption

The mean (SD 95 CI) specimen weight was 141 (102 131-151) g for the entire series The relationship between specimen weight and type of procedure is given in Table 3 The histologic diagnoses for all 414 procedures are given in Table 4 There were 4 instances of complex hyperplasia none of which had been detected at endometrial curettage or biopsy within the previous 6 months

Procedure types

Primary Repeat

procedures procedures

Procedure (n = 305) (n = 109)

EMR alone 121

EMR with myomectomy 109 31 EMR with polypectomy 27 2

EIIR with removal of septum 39 9

Myomectomy alone 7 3 Removal of septum o Adhesiolysis o

EMR = endomyometriol resection

J

60 Journal of Minimally fnvasive Gynecology Vol 20 No JanuaryFebrtliln 211

Table 2

Indication for procedure

Procedure

Menorrhagia

Metorrhagia

Menometorrhagia

Pain

Menorrhagia with pain

Metorrhagia with pain

Hypermenorrhea

Thickened endometrium

Postmenopausal bleeding

Infertility

No of indications

136

3

21

54

128

6

31

17

15

3

There were 11 complications (2700) Eight women (1900) developed infections within the first 36 hours most became febrile within 30 minutes after the procedure and were given parenteral antibiotic therapy None of the infecshytious complications required hospitalization One uterine perforation (0200) occurred with an active electrode requirshying a hospital transfer and diagnostic laparoscopy no visshyceral injury was sustained and the patient was discharged after 48 hours of observation Two uterine ruptures occurred which precluded completion of the procedure Nine addishytional uterine ruptures transpired which neither altered the postoperative course nor precluded completion of the proceshydure In all 9 cases the uterine defect was first noted because of a rapid increase in the patients fluid deficit These defects were generally estimated to be lt5 mm Uterine rupture was differentiated from perforation by careful and immediate reshyview of the digital video recording to determine whether a deshyvice had passed through the uterine serosa In all instances the rupture occurred at the fundus just medial to the midline no ruptures occurred at the cornua Ten women (2400) in whom bleeding exceeded I gmin required uterine tamposhynade using a Foley catheter The catheter was kept in place for 45 minutes to 2 hours before discharge from the office

No complications were attributable to use of any parenshyterally administered analgesics or sedatives Although transhysient mild hypoxemia (oxygen saturation concentration in hemoglobin 8000-9000) did occur such incidents responded quickly to supplemental oxygen in combination with verbal and tactile stimulation In no instances was the use of nalox-

Tissue weight by procedure type

Procedure

EMR

Myomectomy

Repeat operative EMR

EMR = endomyometrial resection

Mean (SD) g Range g

119 (59) 08-380

203 (126) 19-770

75 (60) 1- 380

Table 4

Hi stologic findings

Variable No of findinSI

Normal endo metrium 349

Endometrial polyp 51

Normal myometrium 259 Leiomyoma 149

Complex hyperplasia 4

Adenomyosis 79

one or f1umazenil required There were no instances ofva~

vagal reactions A total of 255 women responded to our telephone sum~

Patients who underwent more than a single procedure durin the study were asked to respond separately for eaGh procemiddot dure Of the 11 women who experienced complications completed the survey representing 3500 of the total respolJshydents Two hundred ten (82400) were very satisfied (95t

confidence interval [CI] 1l9400 to 2l06) and ~~

(16500) were satisfied (9500 CI 1194 to 21061 with the procedure Three women (12) were somewhil dissatisfied (9500 CI -014 to 25400) I because sh thought she had been inadequately sedated and 2 becau( of prolonged nausea and vomiting after the procedure Two hundred forty-nine respondents (976) expressamp preference for an office-based procedure (9500 CI 95 2 to 994500) and only 6 women (2400) (9500 CI[052~ I~ 428) would have preferred a hospital setting Of the D women 1 believed she had been inadequately sedated experienced severe nausea and 3 others (all regjsterc~

nurses) simply explained that they would have been more comfortable in a hospital setting but cited no specific H ciencies Two hundred forty-nine women (980) (9- CI 962800 to 997200) stated they would recommend Ih procedure to a friend Of the 5 who would not recommeru the procedure to a friend 3 women already noted abolt explained that they would have felt more comfortable In

a hospital setting and 2 women stated that they had hopoJ for a better surgical outcome

Discussion

Until the 1990s the role of office-based hysteroscopy 1

limited to its use as a diagnostic tool The introduction of

small-diameter continuous-flow hysteroscopes with ded cated working channels designed to accommodate operatl instruments made it possible for several ground-breakin surgeons [1-4J to treat some uterine and cervical djsea~ middot

in the office setting without cervical dilation thereh avoiding the use of general anesthesia

In 1999 Kung et al [l4J reported the treatment resul t ia 10 women with symptomatic submucous leiomyomas en(jo metria I polyps uterine septae and intrauterine synechiae 1

Wortman

a pilot sl ranging electrod setting ported a office-be perform tal analg rangmg varying

In 20 use of a I copy 1m and subr required removal tor (Smi System ( mately 6 terns ha no large acceptab

More of a 16F going ex cous lei( procedur none req

As tee logic pro office th OBS sett strument Occillsior and can the use ( Notwiths noted tha even wit~ can secti pausal s~

The limit block [24 been doci not obvia [271 Exp while pro siblebutr iss ues in

The e~ most patil 5 to 6 mn of small are comp Bettocchi generaUy

61 nmall et ai Office-based Hysteroscopic Surgery

No of findings

349

51

259

149

4

79

total responshysfied (95

) and 42 to 2106)

the procedure ) expressed CI9572

CI[O52 to tting Of the 6

y edated 2 (all registered ve been more specific defi shy

(980) (95

comfortable in they had hoped

ysteroscopy was introduction of

with dedishy

i pilot study using a variety of small-diameter hysteroscopes mging from l5F to 2lF and 5F Versapoint (Ethicon Inc) t~ctrodes the potential for using this system in an office dling was thus established In 2002 Bettocchi et al [15] reshyfIl rted an observational study of 501 women who underwent office-based treatment of benign intrauterine disease largely [(rformed using the Versapoint system without supplemenshyl analgesia or anesthesia In that study endometrial polyps mUng from 05 to 45 cm and submucous leiomyomas ar ing from 06 to 20 cm were removed

In 2005 Emanuel and Wamsteker [16] first reported the Lr of a hysteroscopic morcellator (Smith amp Nephew Endosshy opy Inc Andover MA) for removal of endometrial polyps d submucous leiomyomas Although the original device

elJuired a 9-mm operative sheath 2 small-diameter tissue moal systems the Truclear 50 Hysteroscopic Morcellashyr (Smith amp Nephew) and the MyoSure Tissue Removal

l)stem (Hologic Inc) are now available in sizes approxishyately 6 mm in diameter While these small-diameter sysshy~s have been designed for office use there are currently

large series that address either their efficacy or patient ceptability in an OBS setting

Iore recently Papalampros et al [17] reported the use a 16F continuous-flow resectoscope in 30 patients undershy

ving excision of polyps ranging from I to 5 cm and submushyJlIS leiomyomas varying from 2 to 3 cm Most of the lOCedures were performed in an outpatient clinic and

ne required more than intracervical anesthesia As technology facilitates the migration of many gynecoshy

middotg ie procedures from the ambulatory surgery center to the fice the limits of what can be reasonably achieved in an ]5 setting is expanding Small-diameter hysteroscopy inshyJrUments have proved their efficacy for diagnosis [18] tubal

lusion [19] and even removal of endometrial polyps l carefully selected myomas [415] often without use of anesthetic blocks or analgesics and sedatives Jrwithstanding these technologic advances Cicinelli [20] ledthat severe pain and adverse effects may occur rarely 11 with mini-instruments Women with a history of cesarshy

section chronic pelvic pain or anxiety or are menoshylIlSal should be considered at risk of pain perception

o limitations of paracervical block [21-23] intracervical -k [2425] and orally administered analgesics [26] have

-En documented Even careful patient selection criteria do obviate vasovagal reactions and moderate surgical pain

IIExpansion of operative hysteroscopy in an OBS setting hlle providing safety and comfort to patients is clearly feashyIe but requires a paradigm shift in thinking about 2 critical middotUes instrumentation and sedation and analgesia The exclusive reliance on small-diameter instruments in

] patients must be questioned Instruments smaller than u6 mm in diameter though well suited for management ~mall polyps leiomyomas and intrauterine synechiae comparatively inefficient for excision of lesionsgt 3 cm tocchi et al [28] observed that the internal cervical orifice ~erally varies from 4 to 5 mm in nulliparous women and

7 to 8 mm in mUltiparous women Given this wide anatomic variation it seems reasonable to conclude that larger instrushyments may be appropriate at least in some circumstances It is worth noting that 2 commonly used endometrial ablation devices the HydroThermAblator System (Boston Scientific Corp Marlborough MA) and the NovaSure (Hologic Inc) use an 8-mm and a 72-mm outside diameter appliance respectively [29] Given that both devices enjoy widespread use in the OBS setting it seems reasonable that hysteroshyscopes of similar diameter should be given greater considershyation for office use The present study demonstrates that 26F and 22F resectoscopes are well tolerated in an office setting in particular with preparatory use of laminaria

It may be argued that our specialty has not embraced the expansion of analgesic and sedation regimens nearly as much as it has welcomed new technology Much of what we know about analgesia and sedation for OBS procedures is derived from studies of pain control during first-trimester surgical abortions [30] The sedation and analgesic regimens that have been studied in women undergoing surgical aborshytion have little applicability in women undergoing hysteroshyscopic surgery a group who are generally older and in whom procedures are lengthier However a recent study of womens preferences for pain control during first-trimester surgical abortion [31] confirms what the ACOG guidelines for office-based surgery [32] already suggest that women feel that pain control decisions should be individualized

Advanced hysteroscopic surgery including endomyomeshytrial resection and removal of polyps septae and all grades of submucous and even intramuralleiomyomas is clearly feasishyble in an OBS setting Even myomas as large as 6 cm and specimens weighing up to 77 g can be safely removed with proper instrumentation sonographic guidance and adequate analgesia and sedation However the safety and high rate of patient satisfaction that we observed is the result of a dedicated and experienced operating room team working toshygether and developing collective knowledge and experience Although we can conclude that the use of small incremental dosages of opiates and sedatives is safe in our particular setshyting it is worth noting that the adoption of advanced operative hysteroscopy came only after mastering these techniques in the controlled environment of an ambulatory surgical center and after many thousands of diagnostic hysteroscopies were performed in the OBS setting with adjuvant use of moderate conscious sedation

The complications that we most commonly observed were infections and uterine rupture The infections likely resulted from the combination of laminaria followed by denudation of the entire endomyometrium Uterine rupture is likely the consequence of using high pump pressures while aggresshysively reducing myometrial thickness during the course of endomyometrial resection Ruptures typically occur at the apex of the uterus just after the electrosurgicalloop is swept across the fundus These defects tend to occur between the midline and the cornua Two important predisposing factors seem to be the presence of a fundal leiomyoma and

l

(

62 Journal ofMinimally Invasive Gynecology Vol 20 No 1 JanuoryFebruary 2013 W Oflll1GIl

a muscular layer lt I cm in thickness as distention occurs Pashytients who experience uterine rupture do not seem to note increased pain during or immediately after the procedure

The present study does not include long-term outcomes however it is worth noting that in women who underwent endomyometrial resection without myomectomy the avershyage specimen weight of 119 g compares favorably with our (MW and AD) previous series that was performed with the patients under general anesthesia [33]

The limitations of the present study include its retrospecshytive nature and that telephone surveys are prone to some elshyement of selection bias inasmuch as dissatisfied patients are less likely to respond Surveys performed at varying intershyvals after the original procedure are likely to be less accurate than surveys conducted within a standardized interval such as 24 to 72 hours after completion Another limiting factor of the present study is that women who experience favorable menstrual outcomes are more apt to report greater rates of satisfaction with office-based surgery Additional studies will be necessary to determine whether the rates of repeat operation in women undergoing office-based hysteroscopic surgery are comparable with those that we have reported in a hospital or ambulatory surgical center setting [33]

Gynecologists considering incorporation of operative hysteroscopy into an OBS setting must carefully consider the costs of initiating such a program Expenses will vary with local regulatory and state medical board requirements equipment that is already available to the practitioner and whether used or new instruments are purchased Many offices may already own much of the necessary paraphernashylia such as an office-appropriate operating room table an electrosurgical generator a video camera with monitor an ultrasound machine and an emergency cart Fluid manageshyment systems and resectoscopes can often be purchased from companies specializing in used medical equipment at a fraction of the cost of their newer models The importance of redundant equipment in particular a second resectoscope cannot be overstated In the final analysis one must consider the expected patient volume and start-up costs before investshying substantial time and resources

Finally one must consider that the benefits to the physishycian are maximized when OBS blends well into the daily pashytient flow of ones practice We find it most useful to schedule operative hysteroscopic procedures as the first case in either the morning or afternoon session Although we have accommodated as many as 6 operative hysteroshyscopic procedures in a week we believe that 1 or 2 proceshydures per week is sufficient for the physician to derive the benefits of OBS while enabling the operating room crew to develop and maintain the necessary skills required for pashytient safety

Conclusions

The advantages of office-based hysteroscopic surgery are 4-fold First it often enables the gynecologist to combine the

diagnostic and treatment phases of patient management obshyviating the need for multiple interventions and anesthetics Second this approach produces substantial cost savings to the insurer and the patient Third many women prefer the fashymiliar environment of the office setting Fourth the physishycian benefits from the ease of scheduling more efficient use of time and improved reimbursement compared with hospital- or ambulatory surgical center-based procedures

There are 2 advantages of a large-diameter resectoscope its efficiency and adaptability to a variety of concomitant procedures It is particularly efficient in removing large quantities of tissue that is not possible with smaller instrushyments Bettocchi et al [15] who have considerable experishyence in removal of leiomyomas and polyps in an OBS setting note that the use of the SF Versapoint electrodes to treat these larger myomas (greater than 2 cm) is time conshysuming and yields lower quality final results In addition the larger-diameter resectoscope is adaptable to all types of hysteroscopic procedures including endomyometrial reshysection polypectomy myomectomy and repeat operative hysteroscopy in many cases 2 of more of these procedures are required in the same patient The use of a single instrushyment obviates the need for multiple specialized instruments such as a nonresectoscopic endometrial ablation device combined with a resectoscope or tissue morcellation apparashytus for management of menorrhagia in a woman with a modshyerately sized submucous leiomyoma

The limitations on hysteroscopic surgery in an OBS setshyting are 3-fold operator skill and experience the existence of intrauterine disease beyond what can be managed with a small-diameter hysteroscope and the capacity to provide patient comfort Patient comfort is critical in performing adshyvanced office-based procedures

We have demonstrated that a large-diameter resectoscope can be safely used in a properly equipped and accredited ofshyfice by a physician working with a dedicated and motivated operating room team However patient satisfaction requires careful consideration of her need for analgesia and sedation

The influx of numerous technologic innovations in the past 2 decades has increased the range of what is possible in an office setting The continued advancement of officeshybased surgery however will depend not only on new technolshyogy but on development of safe effective and proven protocols for administration of adequate sedatives and analgesics in the OBS setting Residency and fellowship proshygrams are encouraged to provide the necessary and extensive training indispensible for managing the challenges of providshying appropriate analgesia and sedation in the office setting

Physicians must consult their state medical boards to meet any formal accreditation requirements Failure to comshyply with regulatory requirements may be grounds for license revocation It is worth noting that as of this writing only 9 states required accreditation once various thresholds have been crossed 25 states have no requirements for officeshybased surgery or office-based anesthesia [3435] In the absence of state regulations for OBS compliance with

both sta IS Impe the gui( particip Practic( most st OBS tf nizatior the pub surance standan

Refere

1 Lind in th

2 Porn in th 3(4 S

3 Se ti uial 2000

4 Bette esthe mell t

S Pract Anc Ane Ane

6 http menl

7 W Ori

a ne 1994

8 http1 htm

9 Pow menl

10 Wort

dorn~

Arne 1994

11 Lo~ guid line

12 Wort rt ec

13 Aldn 1970

14 Kun form LapG

IS Bem term hi po

63 2013 1I1T(1II101l el al Office-based Hysleroscopic Surgery

xIth state and federal Drug Enforcement Agency regulations 16 Emanuel MH Wamsteke r K The intrauterine morcellator a new hys shyteroscopic operating technique to remove intrauterine polyps and myoshy

Ii imperative In addition physicians are urged to adhere to mas J Minim Invasive Gynecol 2005 1262-66

savings to h~ guidelines set forth by the ACOG [32] and to consider 17 Papalampros P Gambadauro P Papadopoulos N et al The minishy

r icipation in the ACOG Safety Certification in Outpatientprefer the fashy resectoscope a new instrument for office hysteroscopic surgery Acta

the physishy IlJctice Excellence (SCOPE) for Women [36] Although Obslet Gynecol Scand 200988227-230

more efficient most states do not demand formal accreditation [35] for 18 Indman PD Office hysteroscopy In Cohen SM editor Operative Lapshyaroscopy and Hysteroscopy New York Churchill Livingstone 1996 wilh 08S the imprimatur of one of the major accreditation orgashyp239-250malions along with the ACOG SCOPE program provides

19 Connor VF Essure a review six years later J Minim II1(yive Gynecol thepublic and the professional staff with a measure of reasshy 200916282-290 urance and confidence that the facility has adhered to a high 20 Cicinelli E Hysteroscopy without anesthesia review of recent literashy

IJndard of clinical care ture J Minim In vasive Gynecology 2010 17703-708 21 Lau WC Lo WK Tam WH Yuen PM Paracervical anesthesia in outshy

References patient hysteroscopy a randomized double-blind placebo-controlledexperishy trial Br J Obstet Gynecol 1999 106356-359

ps in an OBS Lindheim SR Kavic S Shulman SV Sauer MY Operative hysteroscopy 22 Lopes P Giobon E Linet T Phillipe HJ Hysteroscopic tubal sterilizashy

nt electrodes in the office setti ng JAm Assoc Gynecol Laparosc 2000765- 69 tion with Essure intratubal devices a case-control prospective with inert Porreca MR Pansini N Bettocchi S et al Hysteroscopic polypectomy local anesthesia or without anesthesia Eur J Obstet Gynecol Reprod

in the office without anesthesia JAm Assoc Gynecol Laparosc 1996 Bioi 2008 138 199-203 )(4 Suppl)S40 23 Vercellini P Colombo A Mauro F et al Paracervical anesthesia for

Sesti F Marl iali N Santomarco N Hysteroscopic surgery for endomeshy outpatient hystcroscopy Fertil Sleril 199462 1083- 1085 tria l polyps using a bipolar microelectrode Int J Gynaecol Obstet 24 Munro MG Brooks PG Use of loca l anesthesia for office diagnostic ~OOO7 1283- 284 and operative hysteroscopy J Minim Invasi ve Gynecol 201017

- Bettocchi S Ceci 0 Nappi L et al Operative hysteroscopy without anshy 709- 718 elhesia analysis of 4863 cases performed with mechanical instrushy 25 Nagele F OConnor H Davies A et ai 2500 Outpatient diagnostic hysshyment JAm Assoc Gynecol 2004 II 59-61 teroscopies Obstet Gynecol 1996 8887-92

Prac tice Guidelines for Sedation and Analgesia by Nonshy 26 Mercorio F DeSimone R Landi P et al Oral dexketoprofen for pain Anesthesiologists an updated report by the American Society of treatment during diagnostic hysteroscopy in postmenopausal women nestheSiologists Task Force on Sedation and Analgesia by Nonshy Mawritas 2002 10277-28 1 nesthesiologist s Aneslhesiology 200296 1004-1017 27 Raffaele R Lanzone A Tagliaferri V et al Using a 16-French resecto shyRllplwwwnsahqorgFor-MemhersS tandards-Guidel ines-and-S tate scope as an alternative dev ice in the treatment of uterine lesions a ranshyl_ntsaspx Accessed August 12 20 I 2 domized controlled trial Obstet Gynecnl 2012 120 160-165 lIortman M Daggett A Hysteroscopic endomyometrial resection 28 Bettocchi S Nappi L Ccei 0 Selvaggi L What does diagnostic

the existence ~ nell technique for the treatment of menorrhagia Obstet Gynecol hysteroscopy mean today the role of the new techniques Curr

managed with 199482295-298 Opin Obslet Gynecol 2003 15303-308 bllpllwlVwhealthnygovprofessionalsoffice-based_surgerylaw230-d 29 Glasser MH Practical tips for office hysteroscopy and secondshyto provide him Acce~sed Jul y 5 2012 generation global endometrial ablation J Minim Invasive Gynecol perf rming adshy~Oiel SM Hill RK My copilot is a nurse using crew resource manageshy 2009 16384-399 ment in the OR AORN J 200683 179-180 30 Renner RM Jensen JT Nichol MD Edelman AB Pain control in firstshyWortman M Daggett Serum sodium changes during hysteroscopic enshy trimester surgical abortion a systematic rcvicw of randomized conshyilnt)ornetrial resection Paper presented at 23rd Annual Meeting of the trolled trial s Contraception 2010 8 1 372-388 merican Association of Gynecologic Laparoscopists October 18-24 31 Allen R Fortin J Bartz 0 et al Womens preferences for pain control 199 New York NY during first-trimester surgical abortion a qualitative study ContracepshyLoffer FD Bradley LP Brill AI et al Hysteroscopic fluid monitoring liol 20 1285413-418 roidd ines from the Ad Hoc Committee on Hysteroscopic Fluid Guideshy 32 Erickson TB Kirkpatrick DH DeFrancesco MS Executive Summary lines of the AAGL JAm Assoc Gynecol Laparosc 20007 I 67-168 of the American College of Obstetricians and Gynecologists Presidenshynman M Sonographically-guided hysteroscopic endomyometrial tial Task Force on Patient Safety in the Office Setting reinvigorating Ttlion Surg Tech IIlII 201221163-169 safety in office-based gynecologic surgery Obstet Gynecol 20 10

Aldrcte JA Kroulik D A post anesthetic recovery score Anesth Analg 115147-151 19i049924--933 33 Wortman M Daggett A Hysteroscopic endomyometrial resection

and proven unpound Re Vilos GA Thomas B et al A new bipolar system for pershy JSLS 20004 197-207 sedatives and lllmng operative hysteroscopy in normal saline JAm Assoc Gynecol 34 Wortman M Instituting an office-based surgery program in the gyneshy

fellowship proshy UJflllrosC 19993331 -336 cologists office J Minim In vllsive Gynecol 201017673-683 gelloccbi S Ceci 0 DiVenere R et al Advanced operative office hysshy 35 httpwww fsm b orgpd fIgrpo l_regulation_office_based_surgery pdf and extensive tregscopy without anesthesia analysis of 50 I cases treated with a 5 Fr Accessed August 12 20J 2lenges of providshy

rolar electrode Hum Reprod 2002 172435-2438 36 httpwwwscopeforwomenshealthorg Accessed August 152012 office setting ical boards to

ments for officeshya [3435] In the compliance with

Page 2: lVorrml1 OF...Patients: Women undergoing operative hysteroscopy in an office setting, Interventions: Three hundred eighty-seven women underwent a total of 414 operative hysteroscopic

57 NAL O F

LLY INVASIVE TECOLOGY

eview

IOrI)

py in an office-

res with use of II patients were

ed including enshye hundred nine d resection had 102) g of tissue tion of a uterine ications attri butshyy Two hundred 76) preferred Is would recomshy

high degree of Elsevie[ Inc on

ce

your Smart phone can Thi s QR code connect 10 the ussion forum for article now

rlt- t-y ~ r1l1 nG for -OR pp (tore orapp markdplac

hY teroscopes s to pelform

rgical (OBS) include

of office-based by Lindheim

the cost saving ith the hospital

estimate the operative

II gtIIman el af Officemiddotbased Hysteroscopic Surgery

fysteroscopy in an OBS setting to be in the same range obshyrved by Lindheim and colleagues

In 1996 Porreca et al [2] reported a series of 253 women I ho underwent hysteroscopic treatment of endometrial and cervical polyps with 5F instruments and an office hysteroshyope with operative sheath

In 2000 Lindheim et al [1] reported a series of 33 inferti Ie women who underwent various hysteroscopic procedures inshyluding polypectomy myomectomy and adhesiolysis in hich small-diameter hysteroscopes ( 4 mm) were used liang with either mechanical scissors or a Gynecare Versashypoint bipolar electrode (Ethicon Inc Somerville NJ) All orocedures were performed in an OBS setting using

wide variety of analgesic and anesthetic regimens That meyear Sesti et al [3] reported excellent results in a series of 42 women who underwent hysteroscopic polypectomy in ill OBS setting using the Gynecare Versapoint bipolar sysshymand local anesthesia

In 2004 Bettocchi et al [4] reported on 4863 operative h teroscopic procedures performed using a 5 0-mm diameshyer operative hysteroscope and 5F instruments The proceshyiJres included the removal of cervical and endometrial lllyps along with adhesiolysis and repair of anatomic imshyxdiments Bettocchi et al [4] used a vaginoscopic techshylique without analgesics or anesthesia and noted that plients reported little discomfort although those undergoshyngremoval of endometrial polyps were more likely to expeshy

rience moderate discomfort To date all of the reported operative hysteroscopies in

mOBS setting have been performed using small diameter 1 ~ 5 mm) instruments and with few exceptions without 1arenterally administered analgesia or sedation This is he first report of office-based hysteroscopic surgery using

fulI-size 26F (9 mm) operative resectoscope The use of arger instruments parenterally administered agents to lhieve moderate sedation [56] and ultrasound guidance Mbled us to safely perform complex and highly invasive ocedures with a high degree of safety and patient 1tisfaction

llalerials and Methods

Three hundred eighty-seven women underwent a total of 14 operative hysteroscopic procedures in the private office

a physician (MW) with use of a standard 9-mm ont inuous-flow gynecologic resectoscope Procedures nduded endomyometrial resection [7] myomectomy ~lypectomy and repeat surgery after failure of both resecshy

copic and nonresectoscopic endometrial ablation Endoshy)ometrial resection (Fig 1) is the systematic and

eometric approach for removing the entire endomyomeshyrium in long continuous strips of tissue to a depth of 4 to mm below the endometrial basalis in all portions of the (erus the depth is decreased to 2 to 3 mm in the cornual reshyion This is followed by the deep coagulation of the exshyXled myometrium using a ball-end electrode

Endomyomecrial resection

All patients underwent extensive screening including a complete history and physical examination transvaginal ultrasound and selected laboratory studies Formal counselshying included discussion of alternate treatment regimens and the potential for immediate and delayed complications associated with hysteroscopic surgery Most patients did not undergo diagnostic hysteroscopy before the operative procedure

All procedures were performed in a dedicated operating room located within an accredited OBS setting as required under New York State Public Health Law sect230-d [8] Patients above American Society of Anesthesiologists class III were excluded from undergoing a procedure in an OBS setting Numerous patients required formal medical clearance before the procedure and in women aged gt50 years an electrocarshydiogram was obtained within 30 days before the surgery

The operating room team consisted of 5 individuals including the surgeon (MW) a first assistant a trained soshynographer (AD) a fluid management specialist and a regisshytered nurse (CB) dedicated solely to monitoring the patient and administering intravenous analgesics and sedatives All operating room personnel were trained and credentialed in advanced cardiac life support crew resource management [9] and the use of moderate conscious sedation as well as procedure-specific training

In nearly all instances patients were seen the day before surgery for preoperative counseling peri operative instrucshytions and insertion of a 3-mm Iaminaria japonica In patients who requested tubal sterilization Adiana (Hologic Inc Bedford MA) procedures were performed at the time of laminaria insertion although several patients underwent Essure (Conceptus Inc Mountain View CA) sterilization procedures before hysteroscopic surgery Patients were inshyformed that hysterosalpingography would not be feasible as required by the manufacturers instructions for use Pashytients were asked to not eat solid food for a minimum of 4 hours before surgery but were allowed clear liquids until 2 hours before the scheduled operating room time

On the day of surgery an intravenous catheter and hepashyrin lock was placed in all patients and 2 g ampicillin was adshyministered intravenously several minutes before surgery

l

58 Journal of Minimally Invasive Gynecology Vol 20 No 1 January February 2013

Patients allergic to penicillin received either 500 mg metroshynidazole or 300 mg clindamycin intravenously Most pashytients also received 06 mg atropine intravenously just before surgery Patients with a history of narcotic-related nausea often received premedication with 125 to 25 mg promethazine intravenously

Before each procedure the patients maximum allowable fluid absorption (MAFA limit ) [10] was calculated In accorshydance with AAGL [11] guidelines no patient was allowed to absorb more than 1500 mL glycine 15 or 2500 mL norshymal saline solution Whenever the MAFA limir was calculated to be less than allowable according to AAGL guidelines the lesser of the 2 limits was imposed Whenever the MAFAimit exceeded the AAGL guidelines the lesser of the 2 restricshytions was employed

Most procedures were performed using a monopolar 26F (9 mm) continuous-flow resectoscope (Karl Storz Endosshycopy America Inc Culver City CA and Circon-ACMI dishyvision of Circon Corp Stamford CT) occasionally in the presence of marked cervical stenosis or a small postmenoshypausal uterus a 22F (7 mm) resectoscope was used either as the sole instrument or in combination with the larger reshysectoscope Glycine 15 was administered via either the Dolphin (Circon ACMI) or Hamou Endomat (Karl Storz Enshydoscopy America) fluid management system A small numshyber of procedures were performed using a 26F bipolar resectoscope (Karl Storz Endoscopy America) All proceshydures were performed under sonographic guidance using a 35-MHz abdominal transducer placed just above the symshyphysis pubis by one of us (AD)

Nearly all patients received an initial dose of25 to 50 mg midazolam and 50 to 100 Ilg fentanyl intravenously Addishytional doses were given only after a minimum elapsed intershyval of 3 minutes and included no more than 25 mg midazolam or 50 Jlg fentanyl Supplemental medication could include a sedative an opiate or a combination of both In the latter part of the study period during a nationshywide shortage of parenterally administered opiates and benshyzodiazepines nalbuphine hydrochloride and ketamine were used in conjunction with orally administered midazolam

Procedures commenced with removal of the laminaria jashyponica Dilation was performed using a Hegar dilator under sonographic guidance A total of 20 mL saline solution conshytaining 25 U vasopressin was injected intracervically at the 3-0clock and 9-0clock positions using a 21-gauge X IY2shyinch needle After insertion of a continuous-flow resectoshyscope operative procedures were generally initiated with pump pressure varying from 140 to 175 mm Hg and adjusted to balance satisfactory visualization with fluid intravasation The surgeon was apprised of fluid deficits in 50- to 100-mL increments A standard endomyometrial resection technique [7] with only slight modification [12] was used combined with resection of endometrial polyps and removal of submushycous and intramural leiomyomas as they were found All procedures were digitally recorded using a MediCapture USB200 device (MediCapture Inc Philadelphia PA)

Patients recovered in the operating room and were monishytored according to a standardized post-anesthesia recovery protocol described by Aldrete and Kroulik [13] Discharge criteria included a post-anesthesia recovery score (Fig 2) of 9 the ability to walk out of the office (ie without a wheelshychair) and vaginal bleeding lt 1 gmin The next day patients were contacted by one of us (AD or CB) via telephone

A simple patient satisfaction survey form was devised (Fig 3) and attempts were made to contact all patients who had undergone office-based hysteroscopic surgery from March 29 2007 to March 27 2012 The questionnaire was adshyministered as a telephone survey by one of us (AD or CB)

Results

A total of 414 office-based hysteroscopic procedures were performed in 387 patients The mean (SD 95 CI) age of the patients was 442 (69 43 5-449) years Three hundred five women (737) underwent primary proceshydures and the remaining 109 (263) underwent repeat operative procedures after failure of nonresectoscopic endoshymetrial ablation myomectomy or previous endomyometrial resection in procedures performed outside of the present study A summary of the procedures and their indications are given in Tables 1 and 2 respectively

Of the 305 women undergoing a primary hysteroscopic procedure 64 (210) were asked to undergo previous diagshynostic hysteroscopy to determine whether they were suitable candidates for surgery The remaining 79 underwent a sinshygle-stage diagnostic and operative procedure None of the patients requiring repeat surgery were asked to undergo dishyagnostic hysteroscopy Three hundred sixty-four women (87 9) underwent placement of a 3- or 4-mm laminaria japonica on the day before surgery

In 2007 a total of 6 procedures were attempted and comshypleted in our office representing 100 of the total pershyformed that year In 2008 18 procedures representing 27 3 of that years total were achieved in the OBS setting From January 12009 to March 272012 a total of390 proshycedures were performed at our facility representing 980 of the sum performed during those years Of the 8 proceshydures completed in the hospital during that period 1 was pershyformed in an otherwise healthy woman who requested a hospital-based setting and the remaining 7 in patients with medical contraindications to office-based surgery

Four hundred eleven of 414 procedures (993) were completed Three hundred ninety-two (947) were accomshyplished using a combination of parenterally administered midazolam and fentanyl Ninety-eight women (237) with a history of nausea and vomiting due to previously adshyministered anesthetics were premedicated using promethashyzine in doses varying from 125 to 25 mg Of the women receiving the midazolam-fentanyl combination the mean (SD 95 CI) dose required to accomplish the procedure was 1057 (35 1023-1091) mg midazolam and 2001 (885 1916-2086) Jlg fentanyl The duration of the

Wortmallel

Fig 2

Post-anes

procedUi from ad complet were co agent N acombi ing 3 (C

The flu i (421 4

Fig 3

Patient

PalitJ

HOW l

WOtl~

Wool

59 IFebruury 2013

iI(INmall et af Office-based Hysteroscopic Surgery

d were monishysia recovery J Discharge re (Fig 2) of hout a wheelshyt day patients telephone was devised patients who

surgery from nnaire was adshy

0 or CB)

ic procedures SO 95 el) years Three

imary proceshyerwent repeat oscopic endoshydomyometrial f the present ir indications

hysteroscopic previous diagshywere suitable

derwent a sinshy None of the to undergo dishy-four women

mm laminaria

pted and comshythe total pershy

representing e OBS setting tal of 390 proshy

riod I was pershyrequested

7 in patients

of the

Respirations Able to breath deeply and cough freely 2 Dyspnea or limited breathing 1 Apneic (no breathing) o

Circulation BP plusmn 20 of preanesthesia level 2 BP plusmn 21-49 of preanesthesia level 1 BP plusmn50 of preanesthesia level o

Level of consciousness Fully awake 2 Arousable on calling 1 Not responding o

Color Able to maintain oxygen saturationgt 92 on room air 2 Needs oxygen inhalation to maintain oxygen satgt 90 1 Oxygen saturation lt 90 even with oxygen supplement o

A patient MUST have a total score of 8 or higher to be discharged

Post-anesthesia recovery score

Motor

PAR Score [13]

Able to move four extremities voluntarily or on command 2 Able to move two extremities voluntarily or on command I Able to move no extremities voluntarily or on command o

procedure was 376 (135 36 3-38 9) minutes as calculated irom administration of the first dose of midazolam until ompletion Three hundred ninety-two procedures (947) rae completed using glycine 15 as the sole distention gent Nineteen procedures (46) were accomplished using combination of glycine and saline solution and the remainshyng 3 (07) were performed using saline solution alone The fluid deficit of the patients receiving glycine was 461 ni 4204-5016) mL The 22 women who received nor-

Patient satisfaction survey questionnaire

Questionnaire

Palient salisfaclion

How siu i reoare you wi th your procedure _ Very satisfied

Sawtied _ Some what di-satisfied _ Very dis~iltl ti s fied

Would you rClonuncnd this procedure [0 il friend Yes

_No

Would you hilve preferred to have had your procedure pcrformcd in a hoSpital Yes

_No

mal saline solution absorbed 758 (448 5708-9452) mL There were no instances of excess fluid absorption

The mean (SD 95 CI) specimen weight was 141 (102 131-151) g for the entire series The relationship between specimen weight and type of procedure is given in Table 3 The histologic diagnoses for all 414 procedures are given in Table 4 There were 4 instances of complex hyperplasia none of which had been detected at endometrial curettage or biopsy within the previous 6 months

Procedure types

Primary Repeat

procedures procedures

Procedure (n = 305) (n = 109)

EMR alone 121

EMR with myomectomy 109 31 EMR with polypectomy 27 2

EIIR with removal of septum 39 9

Myomectomy alone 7 3 Removal of septum o Adhesiolysis o

EMR = endomyometriol resection

J

60 Journal of Minimally fnvasive Gynecology Vol 20 No JanuaryFebrtliln 211

Table 2

Indication for procedure

Procedure

Menorrhagia

Metorrhagia

Menometorrhagia

Pain

Menorrhagia with pain

Metorrhagia with pain

Hypermenorrhea

Thickened endometrium

Postmenopausal bleeding

Infertility

No of indications

136

3

21

54

128

6

31

17

15

3

There were 11 complications (2700) Eight women (1900) developed infections within the first 36 hours most became febrile within 30 minutes after the procedure and were given parenteral antibiotic therapy None of the infecshytious complications required hospitalization One uterine perforation (0200) occurred with an active electrode requirshying a hospital transfer and diagnostic laparoscopy no visshyceral injury was sustained and the patient was discharged after 48 hours of observation Two uterine ruptures occurred which precluded completion of the procedure Nine addishytional uterine ruptures transpired which neither altered the postoperative course nor precluded completion of the proceshydure In all 9 cases the uterine defect was first noted because of a rapid increase in the patients fluid deficit These defects were generally estimated to be lt5 mm Uterine rupture was differentiated from perforation by careful and immediate reshyview of the digital video recording to determine whether a deshyvice had passed through the uterine serosa In all instances the rupture occurred at the fundus just medial to the midline no ruptures occurred at the cornua Ten women (2400) in whom bleeding exceeded I gmin required uterine tamposhynade using a Foley catheter The catheter was kept in place for 45 minutes to 2 hours before discharge from the office

No complications were attributable to use of any parenshyterally administered analgesics or sedatives Although transhysient mild hypoxemia (oxygen saturation concentration in hemoglobin 8000-9000) did occur such incidents responded quickly to supplemental oxygen in combination with verbal and tactile stimulation In no instances was the use of nalox-

Tissue weight by procedure type

Procedure

EMR

Myomectomy

Repeat operative EMR

EMR = endomyometrial resection

Mean (SD) g Range g

119 (59) 08-380

203 (126) 19-770

75 (60) 1- 380

Table 4

Hi stologic findings

Variable No of findinSI

Normal endo metrium 349

Endometrial polyp 51

Normal myometrium 259 Leiomyoma 149

Complex hyperplasia 4

Adenomyosis 79

one or f1umazenil required There were no instances ofva~

vagal reactions A total of 255 women responded to our telephone sum~

Patients who underwent more than a single procedure durin the study were asked to respond separately for eaGh procemiddot dure Of the 11 women who experienced complications completed the survey representing 3500 of the total respolJshydents Two hundred ten (82400) were very satisfied (95t

confidence interval [CI] 1l9400 to 2l06) and ~~

(16500) were satisfied (9500 CI 1194 to 21061 with the procedure Three women (12) were somewhil dissatisfied (9500 CI -014 to 25400) I because sh thought she had been inadequately sedated and 2 becau( of prolonged nausea and vomiting after the procedure Two hundred forty-nine respondents (976) expressamp preference for an office-based procedure (9500 CI 95 2 to 994500) and only 6 women (2400) (9500 CI[052~ I~ 428) would have preferred a hospital setting Of the D women 1 believed she had been inadequately sedated experienced severe nausea and 3 others (all regjsterc~

nurses) simply explained that they would have been more comfortable in a hospital setting but cited no specific H ciencies Two hundred forty-nine women (980) (9- CI 962800 to 997200) stated they would recommend Ih procedure to a friend Of the 5 who would not recommeru the procedure to a friend 3 women already noted abolt explained that they would have felt more comfortable In

a hospital setting and 2 women stated that they had hopoJ for a better surgical outcome

Discussion

Until the 1990s the role of office-based hysteroscopy 1

limited to its use as a diagnostic tool The introduction of

small-diameter continuous-flow hysteroscopes with ded cated working channels designed to accommodate operatl instruments made it possible for several ground-breakin surgeons [1-4J to treat some uterine and cervical djsea~ middot

in the office setting without cervical dilation thereh avoiding the use of general anesthesia

In 1999 Kung et al [l4J reported the treatment resul t ia 10 women with symptomatic submucous leiomyomas en(jo metria I polyps uterine septae and intrauterine synechiae 1

Wortman

a pilot sl ranging electrod setting ported a office-be perform tal analg rangmg varying

In 20 use of a I copy 1m and subr required removal tor (Smi System ( mately 6 terns ha no large acceptab

More of a 16F going ex cous lei( procedur none req

As tee logic pro office th OBS sett strument Occillsior and can the use ( Notwiths noted tha even wit~ can secti pausal s~

The limit block [24 been doci not obvia [271 Exp while pro siblebutr iss ues in

The e~ most patil 5 to 6 mn of small are comp Bettocchi generaUy

61 nmall et ai Office-based Hysteroscopic Surgery

No of findings

349

51

259

149

4

79

total responshysfied (95

) and 42 to 2106)

the procedure ) expressed CI9572

CI[O52 to tting Of the 6

y edated 2 (all registered ve been more specific defi shy

(980) (95

comfortable in they had hoped

ysteroscopy was introduction of

with dedishy

i pilot study using a variety of small-diameter hysteroscopes mging from l5F to 2lF and 5F Versapoint (Ethicon Inc) t~ctrodes the potential for using this system in an office dling was thus established In 2002 Bettocchi et al [15] reshyfIl rted an observational study of 501 women who underwent office-based treatment of benign intrauterine disease largely [(rformed using the Versapoint system without supplemenshyl analgesia or anesthesia In that study endometrial polyps mUng from 05 to 45 cm and submucous leiomyomas ar ing from 06 to 20 cm were removed

In 2005 Emanuel and Wamsteker [16] first reported the Lr of a hysteroscopic morcellator (Smith amp Nephew Endosshy opy Inc Andover MA) for removal of endometrial polyps d submucous leiomyomas Although the original device

elJuired a 9-mm operative sheath 2 small-diameter tissue moal systems the Truclear 50 Hysteroscopic Morcellashyr (Smith amp Nephew) and the MyoSure Tissue Removal

l)stem (Hologic Inc) are now available in sizes approxishyately 6 mm in diameter While these small-diameter sysshy~s have been designed for office use there are currently

large series that address either their efficacy or patient ceptability in an OBS setting

Iore recently Papalampros et al [17] reported the use a 16F continuous-flow resectoscope in 30 patients undershy

ving excision of polyps ranging from I to 5 cm and submushyJlIS leiomyomas varying from 2 to 3 cm Most of the lOCedures were performed in an outpatient clinic and

ne required more than intracervical anesthesia As technology facilitates the migration of many gynecoshy

middotg ie procedures from the ambulatory surgery center to the fice the limits of what can be reasonably achieved in an ]5 setting is expanding Small-diameter hysteroscopy inshyJrUments have proved their efficacy for diagnosis [18] tubal

lusion [19] and even removal of endometrial polyps l carefully selected myomas [415] often without use of anesthetic blocks or analgesics and sedatives Jrwithstanding these technologic advances Cicinelli [20] ledthat severe pain and adverse effects may occur rarely 11 with mini-instruments Women with a history of cesarshy

section chronic pelvic pain or anxiety or are menoshylIlSal should be considered at risk of pain perception

o limitations of paracervical block [21-23] intracervical -k [2425] and orally administered analgesics [26] have

-En documented Even careful patient selection criteria do obviate vasovagal reactions and moderate surgical pain

IIExpansion of operative hysteroscopy in an OBS setting hlle providing safety and comfort to patients is clearly feashyIe but requires a paradigm shift in thinking about 2 critical middotUes instrumentation and sedation and analgesia The exclusive reliance on small-diameter instruments in

] patients must be questioned Instruments smaller than u6 mm in diameter though well suited for management ~mall polyps leiomyomas and intrauterine synechiae comparatively inefficient for excision of lesionsgt 3 cm tocchi et al [28] observed that the internal cervical orifice ~erally varies from 4 to 5 mm in nulliparous women and

7 to 8 mm in mUltiparous women Given this wide anatomic variation it seems reasonable to conclude that larger instrushyments may be appropriate at least in some circumstances It is worth noting that 2 commonly used endometrial ablation devices the HydroThermAblator System (Boston Scientific Corp Marlborough MA) and the NovaSure (Hologic Inc) use an 8-mm and a 72-mm outside diameter appliance respectively [29] Given that both devices enjoy widespread use in the OBS setting it seems reasonable that hysteroshyscopes of similar diameter should be given greater considershyation for office use The present study demonstrates that 26F and 22F resectoscopes are well tolerated in an office setting in particular with preparatory use of laminaria

It may be argued that our specialty has not embraced the expansion of analgesic and sedation regimens nearly as much as it has welcomed new technology Much of what we know about analgesia and sedation for OBS procedures is derived from studies of pain control during first-trimester surgical abortions [30] The sedation and analgesic regimens that have been studied in women undergoing surgical aborshytion have little applicability in women undergoing hysteroshyscopic surgery a group who are generally older and in whom procedures are lengthier However a recent study of womens preferences for pain control during first-trimester surgical abortion [31] confirms what the ACOG guidelines for office-based surgery [32] already suggest that women feel that pain control decisions should be individualized

Advanced hysteroscopic surgery including endomyomeshytrial resection and removal of polyps septae and all grades of submucous and even intramuralleiomyomas is clearly feasishyble in an OBS setting Even myomas as large as 6 cm and specimens weighing up to 77 g can be safely removed with proper instrumentation sonographic guidance and adequate analgesia and sedation However the safety and high rate of patient satisfaction that we observed is the result of a dedicated and experienced operating room team working toshygether and developing collective knowledge and experience Although we can conclude that the use of small incremental dosages of opiates and sedatives is safe in our particular setshyting it is worth noting that the adoption of advanced operative hysteroscopy came only after mastering these techniques in the controlled environment of an ambulatory surgical center and after many thousands of diagnostic hysteroscopies were performed in the OBS setting with adjuvant use of moderate conscious sedation

The complications that we most commonly observed were infections and uterine rupture The infections likely resulted from the combination of laminaria followed by denudation of the entire endomyometrium Uterine rupture is likely the consequence of using high pump pressures while aggresshysively reducing myometrial thickness during the course of endomyometrial resection Ruptures typically occur at the apex of the uterus just after the electrosurgicalloop is swept across the fundus These defects tend to occur between the midline and the cornua Two important predisposing factors seem to be the presence of a fundal leiomyoma and

l

(

62 Journal ofMinimally Invasive Gynecology Vol 20 No 1 JanuoryFebruary 2013 W Oflll1GIl

a muscular layer lt I cm in thickness as distention occurs Pashytients who experience uterine rupture do not seem to note increased pain during or immediately after the procedure

The present study does not include long-term outcomes however it is worth noting that in women who underwent endomyometrial resection without myomectomy the avershyage specimen weight of 119 g compares favorably with our (MW and AD) previous series that was performed with the patients under general anesthesia [33]

The limitations of the present study include its retrospecshytive nature and that telephone surveys are prone to some elshyement of selection bias inasmuch as dissatisfied patients are less likely to respond Surveys performed at varying intershyvals after the original procedure are likely to be less accurate than surveys conducted within a standardized interval such as 24 to 72 hours after completion Another limiting factor of the present study is that women who experience favorable menstrual outcomes are more apt to report greater rates of satisfaction with office-based surgery Additional studies will be necessary to determine whether the rates of repeat operation in women undergoing office-based hysteroscopic surgery are comparable with those that we have reported in a hospital or ambulatory surgical center setting [33]

Gynecologists considering incorporation of operative hysteroscopy into an OBS setting must carefully consider the costs of initiating such a program Expenses will vary with local regulatory and state medical board requirements equipment that is already available to the practitioner and whether used or new instruments are purchased Many offices may already own much of the necessary paraphernashylia such as an office-appropriate operating room table an electrosurgical generator a video camera with monitor an ultrasound machine and an emergency cart Fluid manageshyment systems and resectoscopes can often be purchased from companies specializing in used medical equipment at a fraction of the cost of their newer models The importance of redundant equipment in particular a second resectoscope cannot be overstated In the final analysis one must consider the expected patient volume and start-up costs before investshying substantial time and resources

Finally one must consider that the benefits to the physishycian are maximized when OBS blends well into the daily pashytient flow of ones practice We find it most useful to schedule operative hysteroscopic procedures as the first case in either the morning or afternoon session Although we have accommodated as many as 6 operative hysteroshyscopic procedures in a week we believe that 1 or 2 proceshydures per week is sufficient for the physician to derive the benefits of OBS while enabling the operating room crew to develop and maintain the necessary skills required for pashytient safety

Conclusions

The advantages of office-based hysteroscopic surgery are 4-fold First it often enables the gynecologist to combine the

diagnostic and treatment phases of patient management obshyviating the need for multiple interventions and anesthetics Second this approach produces substantial cost savings to the insurer and the patient Third many women prefer the fashymiliar environment of the office setting Fourth the physishycian benefits from the ease of scheduling more efficient use of time and improved reimbursement compared with hospital- or ambulatory surgical center-based procedures

There are 2 advantages of a large-diameter resectoscope its efficiency and adaptability to a variety of concomitant procedures It is particularly efficient in removing large quantities of tissue that is not possible with smaller instrushyments Bettocchi et al [15] who have considerable experishyence in removal of leiomyomas and polyps in an OBS setting note that the use of the SF Versapoint electrodes to treat these larger myomas (greater than 2 cm) is time conshysuming and yields lower quality final results In addition the larger-diameter resectoscope is adaptable to all types of hysteroscopic procedures including endomyometrial reshysection polypectomy myomectomy and repeat operative hysteroscopy in many cases 2 of more of these procedures are required in the same patient The use of a single instrushyment obviates the need for multiple specialized instruments such as a nonresectoscopic endometrial ablation device combined with a resectoscope or tissue morcellation apparashytus for management of menorrhagia in a woman with a modshyerately sized submucous leiomyoma

The limitations on hysteroscopic surgery in an OBS setshyting are 3-fold operator skill and experience the existence of intrauterine disease beyond what can be managed with a small-diameter hysteroscope and the capacity to provide patient comfort Patient comfort is critical in performing adshyvanced office-based procedures

We have demonstrated that a large-diameter resectoscope can be safely used in a properly equipped and accredited ofshyfice by a physician working with a dedicated and motivated operating room team However patient satisfaction requires careful consideration of her need for analgesia and sedation

The influx of numerous technologic innovations in the past 2 decades has increased the range of what is possible in an office setting The continued advancement of officeshybased surgery however will depend not only on new technolshyogy but on development of safe effective and proven protocols for administration of adequate sedatives and analgesics in the OBS setting Residency and fellowship proshygrams are encouraged to provide the necessary and extensive training indispensible for managing the challenges of providshying appropriate analgesia and sedation in the office setting

Physicians must consult their state medical boards to meet any formal accreditation requirements Failure to comshyply with regulatory requirements may be grounds for license revocation It is worth noting that as of this writing only 9 states required accreditation once various thresholds have been crossed 25 states have no requirements for officeshybased surgery or office-based anesthesia [3435] In the absence of state regulations for OBS compliance with

both sta IS Impe the gui( particip Practic( most st OBS tf nizatior the pub surance standan

Refere

1 Lind in th

2 Porn in th 3(4 S

3 Se ti uial 2000

4 Bette esthe mell t

S Pract Anc Ane Ane

6 http menl

7 W Ori

a ne 1994

8 http1 htm

9 Pow menl

10 Wort

dorn~

Arne 1994

11 Lo~ guid line

12 Wort rt ec

13 Aldn 1970

14 Kun form LapG

IS Bem term hi po

63 2013 1I1T(1II101l el al Office-based Hysleroscopic Surgery

xIth state and federal Drug Enforcement Agency regulations 16 Emanuel MH Wamsteke r K The intrauterine morcellator a new hys shyteroscopic operating technique to remove intrauterine polyps and myoshy

Ii imperative In addition physicians are urged to adhere to mas J Minim Invasive Gynecol 2005 1262-66

savings to h~ guidelines set forth by the ACOG [32] and to consider 17 Papalampros P Gambadauro P Papadopoulos N et al The minishy

r icipation in the ACOG Safety Certification in Outpatientprefer the fashy resectoscope a new instrument for office hysteroscopic surgery Acta

the physishy IlJctice Excellence (SCOPE) for Women [36] Although Obslet Gynecol Scand 200988227-230

more efficient most states do not demand formal accreditation [35] for 18 Indman PD Office hysteroscopy In Cohen SM editor Operative Lapshyaroscopy and Hysteroscopy New York Churchill Livingstone 1996 wilh 08S the imprimatur of one of the major accreditation orgashyp239-250malions along with the ACOG SCOPE program provides

19 Connor VF Essure a review six years later J Minim II1(yive Gynecol thepublic and the professional staff with a measure of reasshy 200916282-290 urance and confidence that the facility has adhered to a high 20 Cicinelli E Hysteroscopy without anesthesia review of recent literashy

IJndard of clinical care ture J Minim In vasive Gynecology 2010 17703-708 21 Lau WC Lo WK Tam WH Yuen PM Paracervical anesthesia in outshy

References patient hysteroscopy a randomized double-blind placebo-controlledexperishy trial Br J Obstet Gynecol 1999 106356-359

ps in an OBS Lindheim SR Kavic S Shulman SV Sauer MY Operative hysteroscopy 22 Lopes P Giobon E Linet T Phillipe HJ Hysteroscopic tubal sterilizashy

nt electrodes in the office setti ng JAm Assoc Gynecol Laparosc 2000765- 69 tion with Essure intratubal devices a case-control prospective with inert Porreca MR Pansini N Bettocchi S et al Hysteroscopic polypectomy local anesthesia or without anesthesia Eur J Obstet Gynecol Reprod

in the office without anesthesia JAm Assoc Gynecol Laparosc 1996 Bioi 2008 138 199-203 )(4 Suppl)S40 23 Vercellini P Colombo A Mauro F et al Paracervical anesthesia for

Sesti F Marl iali N Santomarco N Hysteroscopic surgery for endomeshy outpatient hystcroscopy Fertil Sleril 199462 1083- 1085 tria l polyps using a bipolar microelectrode Int J Gynaecol Obstet 24 Munro MG Brooks PG Use of loca l anesthesia for office diagnostic ~OOO7 1283- 284 and operative hysteroscopy J Minim Invasi ve Gynecol 201017

- Bettocchi S Ceci 0 Nappi L et al Operative hysteroscopy without anshy 709- 718 elhesia analysis of 4863 cases performed with mechanical instrushy 25 Nagele F OConnor H Davies A et ai 2500 Outpatient diagnostic hysshyment JAm Assoc Gynecol 2004 II 59-61 teroscopies Obstet Gynecol 1996 8887-92

Prac tice Guidelines for Sedation and Analgesia by Nonshy 26 Mercorio F DeSimone R Landi P et al Oral dexketoprofen for pain Anesthesiologists an updated report by the American Society of treatment during diagnostic hysteroscopy in postmenopausal women nestheSiologists Task Force on Sedation and Analgesia by Nonshy Mawritas 2002 10277-28 1 nesthesiologist s Aneslhesiology 200296 1004-1017 27 Raffaele R Lanzone A Tagliaferri V et al Using a 16-French resecto shyRllplwwwnsahqorgFor-MemhersS tandards-Guidel ines-and-S tate scope as an alternative dev ice in the treatment of uterine lesions a ranshyl_ntsaspx Accessed August 12 20 I 2 domized controlled trial Obstet Gynecnl 2012 120 160-165 lIortman M Daggett A Hysteroscopic endomyometrial resection 28 Bettocchi S Nappi L Ccei 0 Selvaggi L What does diagnostic

the existence ~ nell technique for the treatment of menorrhagia Obstet Gynecol hysteroscopy mean today the role of the new techniques Curr

managed with 199482295-298 Opin Obslet Gynecol 2003 15303-308 bllpllwlVwhealthnygovprofessionalsoffice-based_surgerylaw230-d 29 Glasser MH Practical tips for office hysteroscopy and secondshyto provide him Acce~sed Jul y 5 2012 generation global endometrial ablation J Minim Invasive Gynecol perf rming adshy~Oiel SM Hill RK My copilot is a nurse using crew resource manageshy 2009 16384-399 ment in the OR AORN J 200683 179-180 30 Renner RM Jensen JT Nichol MD Edelman AB Pain control in firstshyWortman M Daggett Serum sodium changes during hysteroscopic enshy trimester surgical abortion a systematic rcvicw of randomized conshyilnt)ornetrial resection Paper presented at 23rd Annual Meeting of the trolled trial s Contraception 2010 8 1 372-388 merican Association of Gynecologic Laparoscopists October 18-24 31 Allen R Fortin J Bartz 0 et al Womens preferences for pain control 199 New York NY during first-trimester surgical abortion a qualitative study ContracepshyLoffer FD Bradley LP Brill AI et al Hysteroscopic fluid monitoring liol 20 1285413-418 roidd ines from the Ad Hoc Committee on Hysteroscopic Fluid Guideshy 32 Erickson TB Kirkpatrick DH DeFrancesco MS Executive Summary lines of the AAGL JAm Assoc Gynecol Laparosc 20007 I 67-168 of the American College of Obstetricians and Gynecologists Presidenshynman M Sonographically-guided hysteroscopic endomyometrial tial Task Force on Patient Safety in the Office Setting reinvigorating Ttlion Surg Tech IIlII 201221163-169 safety in office-based gynecologic surgery Obstet Gynecol 20 10

Aldrcte JA Kroulik D A post anesthetic recovery score Anesth Analg 115147-151 19i049924--933 33 Wortman M Daggett A Hysteroscopic endomyometrial resection

and proven unpound Re Vilos GA Thomas B et al A new bipolar system for pershy JSLS 20004 197-207 sedatives and lllmng operative hysteroscopy in normal saline JAm Assoc Gynecol 34 Wortman M Instituting an office-based surgery program in the gyneshy

fellowship proshy UJflllrosC 19993331 -336 cologists office J Minim In vllsive Gynecol 201017673-683 gelloccbi S Ceci 0 DiVenere R et al Advanced operative office hysshy 35 httpwww fsm b orgpd fIgrpo l_regulation_office_based_surgery pdf and extensive tregscopy without anesthesia analysis of 50 I cases treated with a 5 Fr Accessed August 12 20J 2lenges of providshy

rolar electrode Hum Reprod 2002 172435-2438 36 httpwwwscopeforwomenshealthorg Accessed August 152012 office setting ical boards to

ments for officeshya [3435] In the compliance with

Page 3: lVorrml1 OF...Patients: Women undergoing operative hysteroscopy in an office setting, Interventions: Three hundred eighty-seven women underwent a total of 414 operative hysteroscopic

l

58 Journal of Minimally Invasive Gynecology Vol 20 No 1 January February 2013

Patients allergic to penicillin received either 500 mg metroshynidazole or 300 mg clindamycin intravenously Most pashytients also received 06 mg atropine intravenously just before surgery Patients with a history of narcotic-related nausea often received premedication with 125 to 25 mg promethazine intravenously

Before each procedure the patients maximum allowable fluid absorption (MAFA limit ) [10] was calculated In accorshydance with AAGL [11] guidelines no patient was allowed to absorb more than 1500 mL glycine 15 or 2500 mL norshymal saline solution Whenever the MAFA limir was calculated to be less than allowable according to AAGL guidelines the lesser of the 2 limits was imposed Whenever the MAFAimit exceeded the AAGL guidelines the lesser of the 2 restricshytions was employed

Most procedures were performed using a monopolar 26F (9 mm) continuous-flow resectoscope (Karl Storz Endosshycopy America Inc Culver City CA and Circon-ACMI dishyvision of Circon Corp Stamford CT) occasionally in the presence of marked cervical stenosis or a small postmenoshypausal uterus a 22F (7 mm) resectoscope was used either as the sole instrument or in combination with the larger reshysectoscope Glycine 15 was administered via either the Dolphin (Circon ACMI) or Hamou Endomat (Karl Storz Enshydoscopy America) fluid management system A small numshyber of procedures were performed using a 26F bipolar resectoscope (Karl Storz Endoscopy America) All proceshydures were performed under sonographic guidance using a 35-MHz abdominal transducer placed just above the symshyphysis pubis by one of us (AD)

Nearly all patients received an initial dose of25 to 50 mg midazolam and 50 to 100 Ilg fentanyl intravenously Addishytional doses were given only after a minimum elapsed intershyval of 3 minutes and included no more than 25 mg midazolam or 50 Jlg fentanyl Supplemental medication could include a sedative an opiate or a combination of both In the latter part of the study period during a nationshywide shortage of parenterally administered opiates and benshyzodiazepines nalbuphine hydrochloride and ketamine were used in conjunction with orally administered midazolam

Procedures commenced with removal of the laminaria jashyponica Dilation was performed using a Hegar dilator under sonographic guidance A total of 20 mL saline solution conshytaining 25 U vasopressin was injected intracervically at the 3-0clock and 9-0clock positions using a 21-gauge X IY2shyinch needle After insertion of a continuous-flow resectoshyscope operative procedures were generally initiated with pump pressure varying from 140 to 175 mm Hg and adjusted to balance satisfactory visualization with fluid intravasation The surgeon was apprised of fluid deficits in 50- to 100-mL increments A standard endomyometrial resection technique [7] with only slight modification [12] was used combined with resection of endometrial polyps and removal of submushycous and intramural leiomyomas as they were found All procedures were digitally recorded using a MediCapture USB200 device (MediCapture Inc Philadelphia PA)

Patients recovered in the operating room and were monishytored according to a standardized post-anesthesia recovery protocol described by Aldrete and Kroulik [13] Discharge criteria included a post-anesthesia recovery score (Fig 2) of 9 the ability to walk out of the office (ie without a wheelshychair) and vaginal bleeding lt 1 gmin The next day patients were contacted by one of us (AD or CB) via telephone

A simple patient satisfaction survey form was devised (Fig 3) and attempts were made to contact all patients who had undergone office-based hysteroscopic surgery from March 29 2007 to March 27 2012 The questionnaire was adshyministered as a telephone survey by one of us (AD or CB)

Results

A total of 414 office-based hysteroscopic procedures were performed in 387 patients The mean (SD 95 CI) age of the patients was 442 (69 43 5-449) years Three hundred five women (737) underwent primary proceshydures and the remaining 109 (263) underwent repeat operative procedures after failure of nonresectoscopic endoshymetrial ablation myomectomy or previous endomyometrial resection in procedures performed outside of the present study A summary of the procedures and their indications are given in Tables 1 and 2 respectively

Of the 305 women undergoing a primary hysteroscopic procedure 64 (210) were asked to undergo previous diagshynostic hysteroscopy to determine whether they were suitable candidates for surgery The remaining 79 underwent a sinshygle-stage diagnostic and operative procedure None of the patients requiring repeat surgery were asked to undergo dishyagnostic hysteroscopy Three hundred sixty-four women (87 9) underwent placement of a 3- or 4-mm laminaria japonica on the day before surgery

In 2007 a total of 6 procedures were attempted and comshypleted in our office representing 100 of the total pershyformed that year In 2008 18 procedures representing 27 3 of that years total were achieved in the OBS setting From January 12009 to March 272012 a total of390 proshycedures were performed at our facility representing 980 of the sum performed during those years Of the 8 proceshydures completed in the hospital during that period 1 was pershyformed in an otherwise healthy woman who requested a hospital-based setting and the remaining 7 in patients with medical contraindications to office-based surgery

Four hundred eleven of 414 procedures (993) were completed Three hundred ninety-two (947) were accomshyplished using a combination of parenterally administered midazolam and fentanyl Ninety-eight women (237) with a history of nausea and vomiting due to previously adshyministered anesthetics were premedicated using promethashyzine in doses varying from 125 to 25 mg Of the women receiving the midazolam-fentanyl combination the mean (SD 95 CI) dose required to accomplish the procedure was 1057 (35 1023-1091) mg midazolam and 2001 (885 1916-2086) Jlg fentanyl The duration of the

Wortmallel

Fig 2

Post-anes

procedUi from ad complet were co agent N acombi ing 3 (C

The flu i (421 4

Fig 3

Patient

PalitJ

HOW l

WOtl~

Wool

59 IFebruury 2013

iI(INmall et af Office-based Hysteroscopic Surgery

d were monishysia recovery J Discharge re (Fig 2) of hout a wheelshyt day patients telephone was devised patients who

surgery from nnaire was adshy

0 or CB)

ic procedures SO 95 el) years Three

imary proceshyerwent repeat oscopic endoshydomyometrial f the present ir indications

hysteroscopic previous diagshywere suitable

derwent a sinshy None of the to undergo dishy-four women

mm laminaria

pted and comshythe total pershy

representing e OBS setting tal of 390 proshy

riod I was pershyrequested

7 in patients

of the

Respirations Able to breath deeply and cough freely 2 Dyspnea or limited breathing 1 Apneic (no breathing) o

Circulation BP plusmn 20 of preanesthesia level 2 BP plusmn 21-49 of preanesthesia level 1 BP plusmn50 of preanesthesia level o

Level of consciousness Fully awake 2 Arousable on calling 1 Not responding o

Color Able to maintain oxygen saturationgt 92 on room air 2 Needs oxygen inhalation to maintain oxygen satgt 90 1 Oxygen saturation lt 90 even with oxygen supplement o

A patient MUST have a total score of 8 or higher to be discharged

Post-anesthesia recovery score

Motor

PAR Score [13]

Able to move four extremities voluntarily or on command 2 Able to move two extremities voluntarily or on command I Able to move no extremities voluntarily or on command o

procedure was 376 (135 36 3-38 9) minutes as calculated irom administration of the first dose of midazolam until ompletion Three hundred ninety-two procedures (947) rae completed using glycine 15 as the sole distention gent Nineteen procedures (46) were accomplished using combination of glycine and saline solution and the remainshyng 3 (07) were performed using saline solution alone The fluid deficit of the patients receiving glycine was 461 ni 4204-5016) mL The 22 women who received nor-

Patient satisfaction survey questionnaire

Questionnaire

Palient salisfaclion

How siu i reoare you wi th your procedure _ Very satisfied

Sawtied _ Some what di-satisfied _ Very dis~iltl ti s fied

Would you rClonuncnd this procedure [0 il friend Yes

_No

Would you hilve preferred to have had your procedure pcrformcd in a hoSpital Yes

_No

mal saline solution absorbed 758 (448 5708-9452) mL There were no instances of excess fluid absorption

The mean (SD 95 CI) specimen weight was 141 (102 131-151) g for the entire series The relationship between specimen weight and type of procedure is given in Table 3 The histologic diagnoses for all 414 procedures are given in Table 4 There were 4 instances of complex hyperplasia none of which had been detected at endometrial curettage or biopsy within the previous 6 months

Procedure types

Primary Repeat

procedures procedures

Procedure (n = 305) (n = 109)

EMR alone 121

EMR with myomectomy 109 31 EMR with polypectomy 27 2

EIIR with removal of septum 39 9

Myomectomy alone 7 3 Removal of septum o Adhesiolysis o

EMR = endomyometriol resection

J

60 Journal of Minimally fnvasive Gynecology Vol 20 No JanuaryFebrtliln 211

Table 2

Indication for procedure

Procedure

Menorrhagia

Metorrhagia

Menometorrhagia

Pain

Menorrhagia with pain

Metorrhagia with pain

Hypermenorrhea

Thickened endometrium

Postmenopausal bleeding

Infertility

No of indications

136

3

21

54

128

6

31

17

15

3

There were 11 complications (2700) Eight women (1900) developed infections within the first 36 hours most became febrile within 30 minutes after the procedure and were given parenteral antibiotic therapy None of the infecshytious complications required hospitalization One uterine perforation (0200) occurred with an active electrode requirshying a hospital transfer and diagnostic laparoscopy no visshyceral injury was sustained and the patient was discharged after 48 hours of observation Two uterine ruptures occurred which precluded completion of the procedure Nine addishytional uterine ruptures transpired which neither altered the postoperative course nor precluded completion of the proceshydure In all 9 cases the uterine defect was first noted because of a rapid increase in the patients fluid deficit These defects were generally estimated to be lt5 mm Uterine rupture was differentiated from perforation by careful and immediate reshyview of the digital video recording to determine whether a deshyvice had passed through the uterine serosa In all instances the rupture occurred at the fundus just medial to the midline no ruptures occurred at the cornua Ten women (2400) in whom bleeding exceeded I gmin required uterine tamposhynade using a Foley catheter The catheter was kept in place for 45 minutes to 2 hours before discharge from the office

No complications were attributable to use of any parenshyterally administered analgesics or sedatives Although transhysient mild hypoxemia (oxygen saturation concentration in hemoglobin 8000-9000) did occur such incidents responded quickly to supplemental oxygen in combination with verbal and tactile stimulation In no instances was the use of nalox-

Tissue weight by procedure type

Procedure

EMR

Myomectomy

Repeat operative EMR

EMR = endomyometrial resection

Mean (SD) g Range g

119 (59) 08-380

203 (126) 19-770

75 (60) 1- 380

Table 4

Hi stologic findings

Variable No of findinSI

Normal endo metrium 349

Endometrial polyp 51

Normal myometrium 259 Leiomyoma 149

Complex hyperplasia 4

Adenomyosis 79

one or f1umazenil required There were no instances ofva~

vagal reactions A total of 255 women responded to our telephone sum~

Patients who underwent more than a single procedure durin the study were asked to respond separately for eaGh procemiddot dure Of the 11 women who experienced complications completed the survey representing 3500 of the total respolJshydents Two hundred ten (82400) were very satisfied (95t

confidence interval [CI] 1l9400 to 2l06) and ~~

(16500) were satisfied (9500 CI 1194 to 21061 with the procedure Three women (12) were somewhil dissatisfied (9500 CI -014 to 25400) I because sh thought she had been inadequately sedated and 2 becau( of prolonged nausea and vomiting after the procedure Two hundred forty-nine respondents (976) expressamp preference for an office-based procedure (9500 CI 95 2 to 994500) and only 6 women (2400) (9500 CI[052~ I~ 428) would have preferred a hospital setting Of the D women 1 believed she had been inadequately sedated experienced severe nausea and 3 others (all regjsterc~

nurses) simply explained that they would have been more comfortable in a hospital setting but cited no specific H ciencies Two hundred forty-nine women (980) (9- CI 962800 to 997200) stated they would recommend Ih procedure to a friend Of the 5 who would not recommeru the procedure to a friend 3 women already noted abolt explained that they would have felt more comfortable In

a hospital setting and 2 women stated that they had hopoJ for a better surgical outcome

Discussion

Until the 1990s the role of office-based hysteroscopy 1

limited to its use as a diagnostic tool The introduction of

small-diameter continuous-flow hysteroscopes with ded cated working channels designed to accommodate operatl instruments made it possible for several ground-breakin surgeons [1-4J to treat some uterine and cervical djsea~ middot

in the office setting without cervical dilation thereh avoiding the use of general anesthesia

In 1999 Kung et al [l4J reported the treatment resul t ia 10 women with symptomatic submucous leiomyomas en(jo metria I polyps uterine septae and intrauterine synechiae 1

Wortman

a pilot sl ranging electrod setting ported a office-be perform tal analg rangmg varying

In 20 use of a I copy 1m and subr required removal tor (Smi System ( mately 6 terns ha no large acceptab

More of a 16F going ex cous lei( procedur none req

As tee logic pro office th OBS sett strument Occillsior and can the use ( Notwiths noted tha even wit~ can secti pausal s~

The limit block [24 been doci not obvia [271 Exp while pro siblebutr iss ues in

The e~ most patil 5 to 6 mn of small are comp Bettocchi generaUy

61 nmall et ai Office-based Hysteroscopic Surgery

No of findings

349

51

259

149

4

79

total responshysfied (95

) and 42 to 2106)

the procedure ) expressed CI9572

CI[O52 to tting Of the 6

y edated 2 (all registered ve been more specific defi shy

(980) (95

comfortable in they had hoped

ysteroscopy was introduction of

with dedishy

i pilot study using a variety of small-diameter hysteroscopes mging from l5F to 2lF and 5F Versapoint (Ethicon Inc) t~ctrodes the potential for using this system in an office dling was thus established In 2002 Bettocchi et al [15] reshyfIl rted an observational study of 501 women who underwent office-based treatment of benign intrauterine disease largely [(rformed using the Versapoint system without supplemenshyl analgesia or anesthesia In that study endometrial polyps mUng from 05 to 45 cm and submucous leiomyomas ar ing from 06 to 20 cm were removed

In 2005 Emanuel and Wamsteker [16] first reported the Lr of a hysteroscopic morcellator (Smith amp Nephew Endosshy opy Inc Andover MA) for removal of endometrial polyps d submucous leiomyomas Although the original device

elJuired a 9-mm operative sheath 2 small-diameter tissue moal systems the Truclear 50 Hysteroscopic Morcellashyr (Smith amp Nephew) and the MyoSure Tissue Removal

l)stem (Hologic Inc) are now available in sizes approxishyately 6 mm in diameter While these small-diameter sysshy~s have been designed for office use there are currently

large series that address either their efficacy or patient ceptability in an OBS setting

Iore recently Papalampros et al [17] reported the use a 16F continuous-flow resectoscope in 30 patients undershy

ving excision of polyps ranging from I to 5 cm and submushyJlIS leiomyomas varying from 2 to 3 cm Most of the lOCedures were performed in an outpatient clinic and

ne required more than intracervical anesthesia As technology facilitates the migration of many gynecoshy

middotg ie procedures from the ambulatory surgery center to the fice the limits of what can be reasonably achieved in an ]5 setting is expanding Small-diameter hysteroscopy inshyJrUments have proved their efficacy for diagnosis [18] tubal

lusion [19] and even removal of endometrial polyps l carefully selected myomas [415] often without use of anesthetic blocks or analgesics and sedatives Jrwithstanding these technologic advances Cicinelli [20] ledthat severe pain and adverse effects may occur rarely 11 with mini-instruments Women with a history of cesarshy

section chronic pelvic pain or anxiety or are menoshylIlSal should be considered at risk of pain perception

o limitations of paracervical block [21-23] intracervical -k [2425] and orally administered analgesics [26] have

-En documented Even careful patient selection criteria do obviate vasovagal reactions and moderate surgical pain

IIExpansion of operative hysteroscopy in an OBS setting hlle providing safety and comfort to patients is clearly feashyIe but requires a paradigm shift in thinking about 2 critical middotUes instrumentation and sedation and analgesia The exclusive reliance on small-diameter instruments in

] patients must be questioned Instruments smaller than u6 mm in diameter though well suited for management ~mall polyps leiomyomas and intrauterine synechiae comparatively inefficient for excision of lesionsgt 3 cm tocchi et al [28] observed that the internal cervical orifice ~erally varies from 4 to 5 mm in nulliparous women and

7 to 8 mm in mUltiparous women Given this wide anatomic variation it seems reasonable to conclude that larger instrushyments may be appropriate at least in some circumstances It is worth noting that 2 commonly used endometrial ablation devices the HydroThermAblator System (Boston Scientific Corp Marlborough MA) and the NovaSure (Hologic Inc) use an 8-mm and a 72-mm outside diameter appliance respectively [29] Given that both devices enjoy widespread use in the OBS setting it seems reasonable that hysteroshyscopes of similar diameter should be given greater considershyation for office use The present study demonstrates that 26F and 22F resectoscopes are well tolerated in an office setting in particular with preparatory use of laminaria

It may be argued that our specialty has not embraced the expansion of analgesic and sedation regimens nearly as much as it has welcomed new technology Much of what we know about analgesia and sedation for OBS procedures is derived from studies of pain control during first-trimester surgical abortions [30] The sedation and analgesic regimens that have been studied in women undergoing surgical aborshytion have little applicability in women undergoing hysteroshyscopic surgery a group who are generally older and in whom procedures are lengthier However a recent study of womens preferences for pain control during first-trimester surgical abortion [31] confirms what the ACOG guidelines for office-based surgery [32] already suggest that women feel that pain control decisions should be individualized

Advanced hysteroscopic surgery including endomyomeshytrial resection and removal of polyps septae and all grades of submucous and even intramuralleiomyomas is clearly feasishyble in an OBS setting Even myomas as large as 6 cm and specimens weighing up to 77 g can be safely removed with proper instrumentation sonographic guidance and adequate analgesia and sedation However the safety and high rate of patient satisfaction that we observed is the result of a dedicated and experienced operating room team working toshygether and developing collective knowledge and experience Although we can conclude that the use of small incremental dosages of opiates and sedatives is safe in our particular setshyting it is worth noting that the adoption of advanced operative hysteroscopy came only after mastering these techniques in the controlled environment of an ambulatory surgical center and after many thousands of diagnostic hysteroscopies were performed in the OBS setting with adjuvant use of moderate conscious sedation

The complications that we most commonly observed were infections and uterine rupture The infections likely resulted from the combination of laminaria followed by denudation of the entire endomyometrium Uterine rupture is likely the consequence of using high pump pressures while aggresshysively reducing myometrial thickness during the course of endomyometrial resection Ruptures typically occur at the apex of the uterus just after the electrosurgicalloop is swept across the fundus These defects tend to occur between the midline and the cornua Two important predisposing factors seem to be the presence of a fundal leiomyoma and

l

(

62 Journal ofMinimally Invasive Gynecology Vol 20 No 1 JanuoryFebruary 2013 W Oflll1GIl

a muscular layer lt I cm in thickness as distention occurs Pashytients who experience uterine rupture do not seem to note increased pain during or immediately after the procedure

The present study does not include long-term outcomes however it is worth noting that in women who underwent endomyometrial resection without myomectomy the avershyage specimen weight of 119 g compares favorably with our (MW and AD) previous series that was performed with the patients under general anesthesia [33]

The limitations of the present study include its retrospecshytive nature and that telephone surveys are prone to some elshyement of selection bias inasmuch as dissatisfied patients are less likely to respond Surveys performed at varying intershyvals after the original procedure are likely to be less accurate than surveys conducted within a standardized interval such as 24 to 72 hours after completion Another limiting factor of the present study is that women who experience favorable menstrual outcomes are more apt to report greater rates of satisfaction with office-based surgery Additional studies will be necessary to determine whether the rates of repeat operation in women undergoing office-based hysteroscopic surgery are comparable with those that we have reported in a hospital or ambulatory surgical center setting [33]

Gynecologists considering incorporation of operative hysteroscopy into an OBS setting must carefully consider the costs of initiating such a program Expenses will vary with local regulatory and state medical board requirements equipment that is already available to the practitioner and whether used or new instruments are purchased Many offices may already own much of the necessary paraphernashylia such as an office-appropriate operating room table an electrosurgical generator a video camera with monitor an ultrasound machine and an emergency cart Fluid manageshyment systems and resectoscopes can often be purchased from companies specializing in used medical equipment at a fraction of the cost of their newer models The importance of redundant equipment in particular a second resectoscope cannot be overstated In the final analysis one must consider the expected patient volume and start-up costs before investshying substantial time and resources

Finally one must consider that the benefits to the physishycian are maximized when OBS blends well into the daily pashytient flow of ones practice We find it most useful to schedule operative hysteroscopic procedures as the first case in either the morning or afternoon session Although we have accommodated as many as 6 operative hysteroshyscopic procedures in a week we believe that 1 or 2 proceshydures per week is sufficient for the physician to derive the benefits of OBS while enabling the operating room crew to develop and maintain the necessary skills required for pashytient safety

Conclusions

The advantages of office-based hysteroscopic surgery are 4-fold First it often enables the gynecologist to combine the

diagnostic and treatment phases of patient management obshyviating the need for multiple interventions and anesthetics Second this approach produces substantial cost savings to the insurer and the patient Third many women prefer the fashymiliar environment of the office setting Fourth the physishycian benefits from the ease of scheduling more efficient use of time and improved reimbursement compared with hospital- or ambulatory surgical center-based procedures

There are 2 advantages of a large-diameter resectoscope its efficiency and adaptability to a variety of concomitant procedures It is particularly efficient in removing large quantities of tissue that is not possible with smaller instrushyments Bettocchi et al [15] who have considerable experishyence in removal of leiomyomas and polyps in an OBS setting note that the use of the SF Versapoint electrodes to treat these larger myomas (greater than 2 cm) is time conshysuming and yields lower quality final results In addition the larger-diameter resectoscope is adaptable to all types of hysteroscopic procedures including endomyometrial reshysection polypectomy myomectomy and repeat operative hysteroscopy in many cases 2 of more of these procedures are required in the same patient The use of a single instrushyment obviates the need for multiple specialized instruments such as a nonresectoscopic endometrial ablation device combined with a resectoscope or tissue morcellation apparashytus for management of menorrhagia in a woman with a modshyerately sized submucous leiomyoma

The limitations on hysteroscopic surgery in an OBS setshyting are 3-fold operator skill and experience the existence of intrauterine disease beyond what can be managed with a small-diameter hysteroscope and the capacity to provide patient comfort Patient comfort is critical in performing adshyvanced office-based procedures

We have demonstrated that a large-diameter resectoscope can be safely used in a properly equipped and accredited ofshyfice by a physician working with a dedicated and motivated operating room team However patient satisfaction requires careful consideration of her need for analgesia and sedation

The influx of numerous technologic innovations in the past 2 decades has increased the range of what is possible in an office setting The continued advancement of officeshybased surgery however will depend not only on new technolshyogy but on development of safe effective and proven protocols for administration of adequate sedatives and analgesics in the OBS setting Residency and fellowship proshygrams are encouraged to provide the necessary and extensive training indispensible for managing the challenges of providshying appropriate analgesia and sedation in the office setting

Physicians must consult their state medical boards to meet any formal accreditation requirements Failure to comshyply with regulatory requirements may be grounds for license revocation It is worth noting that as of this writing only 9 states required accreditation once various thresholds have been crossed 25 states have no requirements for officeshybased surgery or office-based anesthesia [3435] In the absence of state regulations for OBS compliance with

both sta IS Impe the gui( particip Practic( most st OBS tf nizatior the pub surance standan

Refere

1 Lind in th

2 Porn in th 3(4 S

3 Se ti uial 2000

4 Bette esthe mell t

S Pract Anc Ane Ane

6 http menl

7 W Ori

a ne 1994

8 http1 htm

9 Pow menl

10 Wort

dorn~

Arne 1994

11 Lo~ guid line

12 Wort rt ec

13 Aldn 1970

14 Kun form LapG

IS Bem term hi po

63 2013 1I1T(1II101l el al Office-based Hysleroscopic Surgery

xIth state and federal Drug Enforcement Agency regulations 16 Emanuel MH Wamsteke r K The intrauterine morcellator a new hys shyteroscopic operating technique to remove intrauterine polyps and myoshy

Ii imperative In addition physicians are urged to adhere to mas J Minim Invasive Gynecol 2005 1262-66

savings to h~ guidelines set forth by the ACOG [32] and to consider 17 Papalampros P Gambadauro P Papadopoulos N et al The minishy

r icipation in the ACOG Safety Certification in Outpatientprefer the fashy resectoscope a new instrument for office hysteroscopic surgery Acta

the physishy IlJctice Excellence (SCOPE) for Women [36] Although Obslet Gynecol Scand 200988227-230

more efficient most states do not demand formal accreditation [35] for 18 Indman PD Office hysteroscopy In Cohen SM editor Operative Lapshyaroscopy and Hysteroscopy New York Churchill Livingstone 1996 wilh 08S the imprimatur of one of the major accreditation orgashyp239-250malions along with the ACOG SCOPE program provides

19 Connor VF Essure a review six years later J Minim II1(yive Gynecol thepublic and the professional staff with a measure of reasshy 200916282-290 urance and confidence that the facility has adhered to a high 20 Cicinelli E Hysteroscopy without anesthesia review of recent literashy

IJndard of clinical care ture J Minim In vasive Gynecology 2010 17703-708 21 Lau WC Lo WK Tam WH Yuen PM Paracervical anesthesia in outshy

References patient hysteroscopy a randomized double-blind placebo-controlledexperishy trial Br J Obstet Gynecol 1999 106356-359

ps in an OBS Lindheim SR Kavic S Shulman SV Sauer MY Operative hysteroscopy 22 Lopes P Giobon E Linet T Phillipe HJ Hysteroscopic tubal sterilizashy

nt electrodes in the office setti ng JAm Assoc Gynecol Laparosc 2000765- 69 tion with Essure intratubal devices a case-control prospective with inert Porreca MR Pansini N Bettocchi S et al Hysteroscopic polypectomy local anesthesia or without anesthesia Eur J Obstet Gynecol Reprod

in the office without anesthesia JAm Assoc Gynecol Laparosc 1996 Bioi 2008 138 199-203 )(4 Suppl)S40 23 Vercellini P Colombo A Mauro F et al Paracervical anesthesia for

Sesti F Marl iali N Santomarco N Hysteroscopic surgery for endomeshy outpatient hystcroscopy Fertil Sleril 199462 1083- 1085 tria l polyps using a bipolar microelectrode Int J Gynaecol Obstet 24 Munro MG Brooks PG Use of loca l anesthesia for office diagnostic ~OOO7 1283- 284 and operative hysteroscopy J Minim Invasi ve Gynecol 201017

- Bettocchi S Ceci 0 Nappi L et al Operative hysteroscopy without anshy 709- 718 elhesia analysis of 4863 cases performed with mechanical instrushy 25 Nagele F OConnor H Davies A et ai 2500 Outpatient diagnostic hysshyment JAm Assoc Gynecol 2004 II 59-61 teroscopies Obstet Gynecol 1996 8887-92

Prac tice Guidelines for Sedation and Analgesia by Nonshy 26 Mercorio F DeSimone R Landi P et al Oral dexketoprofen for pain Anesthesiologists an updated report by the American Society of treatment during diagnostic hysteroscopy in postmenopausal women nestheSiologists Task Force on Sedation and Analgesia by Nonshy Mawritas 2002 10277-28 1 nesthesiologist s Aneslhesiology 200296 1004-1017 27 Raffaele R Lanzone A Tagliaferri V et al Using a 16-French resecto shyRllplwwwnsahqorgFor-MemhersS tandards-Guidel ines-and-S tate scope as an alternative dev ice in the treatment of uterine lesions a ranshyl_ntsaspx Accessed August 12 20 I 2 domized controlled trial Obstet Gynecnl 2012 120 160-165 lIortman M Daggett A Hysteroscopic endomyometrial resection 28 Bettocchi S Nappi L Ccei 0 Selvaggi L What does diagnostic

the existence ~ nell technique for the treatment of menorrhagia Obstet Gynecol hysteroscopy mean today the role of the new techniques Curr

managed with 199482295-298 Opin Obslet Gynecol 2003 15303-308 bllpllwlVwhealthnygovprofessionalsoffice-based_surgerylaw230-d 29 Glasser MH Practical tips for office hysteroscopy and secondshyto provide him Acce~sed Jul y 5 2012 generation global endometrial ablation J Minim Invasive Gynecol perf rming adshy~Oiel SM Hill RK My copilot is a nurse using crew resource manageshy 2009 16384-399 ment in the OR AORN J 200683 179-180 30 Renner RM Jensen JT Nichol MD Edelman AB Pain control in firstshyWortman M Daggett Serum sodium changes during hysteroscopic enshy trimester surgical abortion a systematic rcvicw of randomized conshyilnt)ornetrial resection Paper presented at 23rd Annual Meeting of the trolled trial s Contraception 2010 8 1 372-388 merican Association of Gynecologic Laparoscopists October 18-24 31 Allen R Fortin J Bartz 0 et al Womens preferences for pain control 199 New York NY during first-trimester surgical abortion a qualitative study ContracepshyLoffer FD Bradley LP Brill AI et al Hysteroscopic fluid monitoring liol 20 1285413-418 roidd ines from the Ad Hoc Committee on Hysteroscopic Fluid Guideshy 32 Erickson TB Kirkpatrick DH DeFrancesco MS Executive Summary lines of the AAGL JAm Assoc Gynecol Laparosc 20007 I 67-168 of the American College of Obstetricians and Gynecologists Presidenshynman M Sonographically-guided hysteroscopic endomyometrial tial Task Force on Patient Safety in the Office Setting reinvigorating Ttlion Surg Tech IIlII 201221163-169 safety in office-based gynecologic surgery Obstet Gynecol 20 10

Aldrcte JA Kroulik D A post anesthetic recovery score Anesth Analg 115147-151 19i049924--933 33 Wortman M Daggett A Hysteroscopic endomyometrial resection

and proven unpound Re Vilos GA Thomas B et al A new bipolar system for pershy JSLS 20004 197-207 sedatives and lllmng operative hysteroscopy in normal saline JAm Assoc Gynecol 34 Wortman M Instituting an office-based surgery program in the gyneshy

fellowship proshy UJflllrosC 19993331 -336 cologists office J Minim In vllsive Gynecol 201017673-683 gelloccbi S Ceci 0 DiVenere R et al Advanced operative office hysshy 35 httpwww fsm b orgpd fIgrpo l_regulation_office_based_surgery pdf and extensive tregscopy without anesthesia analysis of 50 I cases treated with a 5 Fr Accessed August 12 20J 2lenges of providshy

rolar electrode Hum Reprod 2002 172435-2438 36 httpwwwscopeforwomenshealthorg Accessed August 152012 office setting ical boards to

ments for officeshya [3435] In the compliance with

Page 4: lVorrml1 OF...Patients: Women undergoing operative hysteroscopy in an office setting, Interventions: Three hundred eighty-seven women underwent a total of 414 operative hysteroscopic

59 IFebruury 2013

iI(INmall et af Office-based Hysteroscopic Surgery

d were monishysia recovery J Discharge re (Fig 2) of hout a wheelshyt day patients telephone was devised patients who

surgery from nnaire was adshy

0 or CB)

ic procedures SO 95 el) years Three

imary proceshyerwent repeat oscopic endoshydomyometrial f the present ir indications

hysteroscopic previous diagshywere suitable

derwent a sinshy None of the to undergo dishy-four women

mm laminaria

pted and comshythe total pershy

representing e OBS setting tal of 390 proshy

riod I was pershyrequested

7 in patients

of the

Respirations Able to breath deeply and cough freely 2 Dyspnea or limited breathing 1 Apneic (no breathing) o

Circulation BP plusmn 20 of preanesthesia level 2 BP plusmn 21-49 of preanesthesia level 1 BP plusmn50 of preanesthesia level o

Level of consciousness Fully awake 2 Arousable on calling 1 Not responding o

Color Able to maintain oxygen saturationgt 92 on room air 2 Needs oxygen inhalation to maintain oxygen satgt 90 1 Oxygen saturation lt 90 even with oxygen supplement o

A patient MUST have a total score of 8 or higher to be discharged

Post-anesthesia recovery score

Motor

PAR Score [13]

Able to move four extremities voluntarily or on command 2 Able to move two extremities voluntarily or on command I Able to move no extremities voluntarily or on command o

procedure was 376 (135 36 3-38 9) minutes as calculated irom administration of the first dose of midazolam until ompletion Three hundred ninety-two procedures (947) rae completed using glycine 15 as the sole distention gent Nineteen procedures (46) were accomplished using combination of glycine and saline solution and the remainshyng 3 (07) were performed using saline solution alone The fluid deficit of the patients receiving glycine was 461 ni 4204-5016) mL The 22 women who received nor-

Patient satisfaction survey questionnaire

Questionnaire

Palient salisfaclion

How siu i reoare you wi th your procedure _ Very satisfied

Sawtied _ Some what di-satisfied _ Very dis~iltl ti s fied

Would you rClonuncnd this procedure [0 il friend Yes

_No

Would you hilve preferred to have had your procedure pcrformcd in a hoSpital Yes

_No

mal saline solution absorbed 758 (448 5708-9452) mL There were no instances of excess fluid absorption

The mean (SD 95 CI) specimen weight was 141 (102 131-151) g for the entire series The relationship between specimen weight and type of procedure is given in Table 3 The histologic diagnoses for all 414 procedures are given in Table 4 There were 4 instances of complex hyperplasia none of which had been detected at endometrial curettage or biopsy within the previous 6 months

Procedure types

Primary Repeat

procedures procedures

Procedure (n = 305) (n = 109)

EMR alone 121

EMR with myomectomy 109 31 EMR with polypectomy 27 2

EIIR with removal of septum 39 9

Myomectomy alone 7 3 Removal of septum o Adhesiolysis o

EMR = endomyometriol resection

J

60 Journal of Minimally fnvasive Gynecology Vol 20 No JanuaryFebrtliln 211

Table 2

Indication for procedure

Procedure

Menorrhagia

Metorrhagia

Menometorrhagia

Pain

Menorrhagia with pain

Metorrhagia with pain

Hypermenorrhea

Thickened endometrium

Postmenopausal bleeding

Infertility

No of indications

136

3

21

54

128

6

31

17

15

3

There were 11 complications (2700) Eight women (1900) developed infections within the first 36 hours most became febrile within 30 minutes after the procedure and were given parenteral antibiotic therapy None of the infecshytious complications required hospitalization One uterine perforation (0200) occurred with an active electrode requirshying a hospital transfer and diagnostic laparoscopy no visshyceral injury was sustained and the patient was discharged after 48 hours of observation Two uterine ruptures occurred which precluded completion of the procedure Nine addishytional uterine ruptures transpired which neither altered the postoperative course nor precluded completion of the proceshydure In all 9 cases the uterine defect was first noted because of a rapid increase in the patients fluid deficit These defects were generally estimated to be lt5 mm Uterine rupture was differentiated from perforation by careful and immediate reshyview of the digital video recording to determine whether a deshyvice had passed through the uterine serosa In all instances the rupture occurred at the fundus just medial to the midline no ruptures occurred at the cornua Ten women (2400) in whom bleeding exceeded I gmin required uterine tamposhynade using a Foley catheter The catheter was kept in place for 45 minutes to 2 hours before discharge from the office

No complications were attributable to use of any parenshyterally administered analgesics or sedatives Although transhysient mild hypoxemia (oxygen saturation concentration in hemoglobin 8000-9000) did occur such incidents responded quickly to supplemental oxygen in combination with verbal and tactile stimulation In no instances was the use of nalox-

Tissue weight by procedure type

Procedure

EMR

Myomectomy

Repeat operative EMR

EMR = endomyometrial resection

Mean (SD) g Range g

119 (59) 08-380

203 (126) 19-770

75 (60) 1- 380

Table 4

Hi stologic findings

Variable No of findinSI

Normal endo metrium 349

Endometrial polyp 51

Normal myometrium 259 Leiomyoma 149

Complex hyperplasia 4

Adenomyosis 79

one or f1umazenil required There were no instances ofva~

vagal reactions A total of 255 women responded to our telephone sum~

Patients who underwent more than a single procedure durin the study were asked to respond separately for eaGh procemiddot dure Of the 11 women who experienced complications completed the survey representing 3500 of the total respolJshydents Two hundred ten (82400) were very satisfied (95t

confidence interval [CI] 1l9400 to 2l06) and ~~

(16500) were satisfied (9500 CI 1194 to 21061 with the procedure Three women (12) were somewhil dissatisfied (9500 CI -014 to 25400) I because sh thought she had been inadequately sedated and 2 becau( of prolonged nausea and vomiting after the procedure Two hundred forty-nine respondents (976) expressamp preference for an office-based procedure (9500 CI 95 2 to 994500) and only 6 women (2400) (9500 CI[052~ I~ 428) would have preferred a hospital setting Of the D women 1 believed she had been inadequately sedated experienced severe nausea and 3 others (all regjsterc~

nurses) simply explained that they would have been more comfortable in a hospital setting but cited no specific H ciencies Two hundred forty-nine women (980) (9- CI 962800 to 997200) stated they would recommend Ih procedure to a friend Of the 5 who would not recommeru the procedure to a friend 3 women already noted abolt explained that they would have felt more comfortable In

a hospital setting and 2 women stated that they had hopoJ for a better surgical outcome

Discussion

Until the 1990s the role of office-based hysteroscopy 1

limited to its use as a diagnostic tool The introduction of

small-diameter continuous-flow hysteroscopes with ded cated working channels designed to accommodate operatl instruments made it possible for several ground-breakin surgeons [1-4J to treat some uterine and cervical djsea~ middot

in the office setting without cervical dilation thereh avoiding the use of general anesthesia

In 1999 Kung et al [l4J reported the treatment resul t ia 10 women with symptomatic submucous leiomyomas en(jo metria I polyps uterine septae and intrauterine synechiae 1

Wortman

a pilot sl ranging electrod setting ported a office-be perform tal analg rangmg varying

In 20 use of a I copy 1m and subr required removal tor (Smi System ( mately 6 terns ha no large acceptab

More of a 16F going ex cous lei( procedur none req

As tee logic pro office th OBS sett strument Occillsior and can the use ( Notwiths noted tha even wit~ can secti pausal s~

The limit block [24 been doci not obvia [271 Exp while pro siblebutr iss ues in

The e~ most patil 5 to 6 mn of small are comp Bettocchi generaUy

61 nmall et ai Office-based Hysteroscopic Surgery

No of findings

349

51

259

149

4

79

total responshysfied (95

) and 42 to 2106)

the procedure ) expressed CI9572

CI[O52 to tting Of the 6

y edated 2 (all registered ve been more specific defi shy

(980) (95

comfortable in they had hoped

ysteroscopy was introduction of

with dedishy

i pilot study using a variety of small-diameter hysteroscopes mging from l5F to 2lF and 5F Versapoint (Ethicon Inc) t~ctrodes the potential for using this system in an office dling was thus established In 2002 Bettocchi et al [15] reshyfIl rted an observational study of 501 women who underwent office-based treatment of benign intrauterine disease largely [(rformed using the Versapoint system without supplemenshyl analgesia or anesthesia In that study endometrial polyps mUng from 05 to 45 cm and submucous leiomyomas ar ing from 06 to 20 cm were removed

In 2005 Emanuel and Wamsteker [16] first reported the Lr of a hysteroscopic morcellator (Smith amp Nephew Endosshy opy Inc Andover MA) for removal of endometrial polyps d submucous leiomyomas Although the original device

elJuired a 9-mm operative sheath 2 small-diameter tissue moal systems the Truclear 50 Hysteroscopic Morcellashyr (Smith amp Nephew) and the MyoSure Tissue Removal

l)stem (Hologic Inc) are now available in sizes approxishyately 6 mm in diameter While these small-diameter sysshy~s have been designed for office use there are currently

large series that address either their efficacy or patient ceptability in an OBS setting

Iore recently Papalampros et al [17] reported the use a 16F continuous-flow resectoscope in 30 patients undershy

ving excision of polyps ranging from I to 5 cm and submushyJlIS leiomyomas varying from 2 to 3 cm Most of the lOCedures were performed in an outpatient clinic and

ne required more than intracervical anesthesia As technology facilitates the migration of many gynecoshy

middotg ie procedures from the ambulatory surgery center to the fice the limits of what can be reasonably achieved in an ]5 setting is expanding Small-diameter hysteroscopy inshyJrUments have proved their efficacy for diagnosis [18] tubal

lusion [19] and even removal of endometrial polyps l carefully selected myomas [415] often without use of anesthetic blocks or analgesics and sedatives Jrwithstanding these technologic advances Cicinelli [20] ledthat severe pain and adverse effects may occur rarely 11 with mini-instruments Women with a history of cesarshy

section chronic pelvic pain or anxiety or are menoshylIlSal should be considered at risk of pain perception

o limitations of paracervical block [21-23] intracervical -k [2425] and orally administered analgesics [26] have

-En documented Even careful patient selection criteria do obviate vasovagal reactions and moderate surgical pain

IIExpansion of operative hysteroscopy in an OBS setting hlle providing safety and comfort to patients is clearly feashyIe but requires a paradigm shift in thinking about 2 critical middotUes instrumentation and sedation and analgesia The exclusive reliance on small-diameter instruments in

] patients must be questioned Instruments smaller than u6 mm in diameter though well suited for management ~mall polyps leiomyomas and intrauterine synechiae comparatively inefficient for excision of lesionsgt 3 cm tocchi et al [28] observed that the internal cervical orifice ~erally varies from 4 to 5 mm in nulliparous women and

7 to 8 mm in mUltiparous women Given this wide anatomic variation it seems reasonable to conclude that larger instrushyments may be appropriate at least in some circumstances It is worth noting that 2 commonly used endometrial ablation devices the HydroThermAblator System (Boston Scientific Corp Marlborough MA) and the NovaSure (Hologic Inc) use an 8-mm and a 72-mm outside diameter appliance respectively [29] Given that both devices enjoy widespread use in the OBS setting it seems reasonable that hysteroshyscopes of similar diameter should be given greater considershyation for office use The present study demonstrates that 26F and 22F resectoscopes are well tolerated in an office setting in particular with preparatory use of laminaria

It may be argued that our specialty has not embraced the expansion of analgesic and sedation regimens nearly as much as it has welcomed new technology Much of what we know about analgesia and sedation for OBS procedures is derived from studies of pain control during first-trimester surgical abortions [30] The sedation and analgesic regimens that have been studied in women undergoing surgical aborshytion have little applicability in women undergoing hysteroshyscopic surgery a group who are generally older and in whom procedures are lengthier However a recent study of womens preferences for pain control during first-trimester surgical abortion [31] confirms what the ACOG guidelines for office-based surgery [32] already suggest that women feel that pain control decisions should be individualized

Advanced hysteroscopic surgery including endomyomeshytrial resection and removal of polyps septae and all grades of submucous and even intramuralleiomyomas is clearly feasishyble in an OBS setting Even myomas as large as 6 cm and specimens weighing up to 77 g can be safely removed with proper instrumentation sonographic guidance and adequate analgesia and sedation However the safety and high rate of patient satisfaction that we observed is the result of a dedicated and experienced operating room team working toshygether and developing collective knowledge and experience Although we can conclude that the use of small incremental dosages of opiates and sedatives is safe in our particular setshyting it is worth noting that the adoption of advanced operative hysteroscopy came only after mastering these techniques in the controlled environment of an ambulatory surgical center and after many thousands of diagnostic hysteroscopies were performed in the OBS setting with adjuvant use of moderate conscious sedation

The complications that we most commonly observed were infections and uterine rupture The infections likely resulted from the combination of laminaria followed by denudation of the entire endomyometrium Uterine rupture is likely the consequence of using high pump pressures while aggresshysively reducing myometrial thickness during the course of endomyometrial resection Ruptures typically occur at the apex of the uterus just after the electrosurgicalloop is swept across the fundus These defects tend to occur between the midline and the cornua Two important predisposing factors seem to be the presence of a fundal leiomyoma and

l

(

62 Journal ofMinimally Invasive Gynecology Vol 20 No 1 JanuoryFebruary 2013 W Oflll1GIl

a muscular layer lt I cm in thickness as distention occurs Pashytients who experience uterine rupture do not seem to note increased pain during or immediately after the procedure

The present study does not include long-term outcomes however it is worth noting that in women who underwent endomyometrial resection without myomectomy the avershyage specimen weight of 119 g compares favorably with our (MW and AD) previous series that was performed with the patients under general anesthesia [33]

The limitations of the present study include its retrospecshytive nature and that telephone surveys are prone to some elshyement of selection bias inasmuch as dissatisfied patients are less likely to respond Surveys performed at varying intershyvals after the original procedure are likely to be less accurate than surveys conducted within a standardized interval such as 24 to 72 hours after completion Another limiting factor of the present study is that women who experience favorable menstrual outcomes are more apt to report greater rates of satisfaction with office-based surgery Additional studies will be necessary to determine whether the rates of repeat operation in women undergoing office-based hysteroscopic surgery are comparable with those that we have reported in a hospital or ambulatory surgical center setting [33]

Gynecologists considering incorporation of operative hysteroscopy into an OBS setting must carefully consider the costs of initiating such a program Expenses will vary with local regulatory and state medical board requirements equipment that is already available to the practitioner and whether used or new instruments are purchased Many offices may already own much of the necessary paraphernashylia such as an office-appropriate operating room table an electrosurgical generator a video camera with monitor an ultrasound machine and an emergency cart Fluid manageshyment systems and resectoscopes can often be purchased from companies specializing in used medical equipment at a fraction of the cost of their newer models The importance of redundant equipment in particular a second resectoscope cannot be overstated In the final analysis one must consider the expected patient volume and start-up costs before investshying substantial time and resources

Finally one must consider that the benefits to the physishycian are maximized when OBS blends well into the daily pashytient flow of ones practice We find it most useful to schedule operative hysteroscopic procedures as the first case in either the morning or afternoon session Although we have accommodated as many as 6 operative hysteroshyscopic procedures in a week we believe that 1 or 2 proceshydures per week is sufficient for the physician to derive the benefits of OBS while enabling the operating room crew to develop and maintain the necessary skills required for pashytient safety

Conclusions

The advantages of office-based hysteroscopic surgery are 4-fold First it often enables the gynecologist to combine the

diagnostic and treatment phases of patient management obshyviating the need for multiple interventions and anesthetics Second this approach produces substantial cost savings to the insurer and the patient Third many women prefer the fashymiliar environment of the office setting Fourth the physishycian benefits from the ease of scheduling more efficient use of time and improved reimbursement compared with hospital- or ambulatory surgical center-based procedures

There are 2 advantages of a large-diameter resectoscope its efficiency and adaptability to a variety of concomitant procedures It is particularly efficient in removing large quantities of tissue that is not possible with smaller instrushyments Bettocchi et al [15] who have considerable experishyence in removal of leiomyomas and polyps in an OBS setting note that the use of the SF Versapoint electrodes to treat these larger myomas (greater than 2 cm) is time conshysuming and yields lower quality final results In addition the larger-diameter resectoscope is adaptable to all types of hysteroscopic procedures including endomyometrial reshysection polypectomy myomectomy and repeat operative hysteroscopy in many cases 2 of more of these procedures are required in the same patient The use of a single instrushyment obviates the need for multiple specialized instruments such as a nonresectoscopic endometrial ablation device combined with a resectoscope or tissue morcellation apparashytus for management of menorrhagia in a woman with a modshyerately sized submucous leiomyoma

The limitations on hysteroscopic surgery in an OBS setshyting are 3-fold operator skill and experience the existence of intrauterine disease beyond what can be managed with a small-diameter hysteroscope and the capacity to provide patient comfort Patient comfort is critical in performing adshyvanced office-based procedures

We have demonstrated that a large-diameter resectoscope can be safely used in a properly equipped and accredited ofshyfice by a physician working with a dedicated and motivated operating room team However patient satisfaction requires careful consideration of her need for analgesia and sedation

The influx of numerous technologic innovations in the past 2 decades has increased the range of what is possible in an office setting The continued advancement of officeshybased surgery however will depend not only on new technolshyogy but on development of safe effective and proven protocols for administration of adequate sedatives and analgesics in the OBS setting Residency and fellowship proshygrams are encouraged to provide the necessary and extensive training indispensible for managing the challenges of providshying appropriate analgesia and sedation in the office setting

Physicians must consult their state medical boards to meet any formal accreditation requirements Failure to comshyply with regulatory requirements may be grounds for license revocation It is worth noting that as of this writing only 9 states required accreditation once various thresholds have been crossed 25 states have no requirements for officeshybased surgery or office-based anesthesia [3435] In the absence of state regulations for OBS compliance with

both sta IS Impe the gui( particip Practic( most st OBS tf nizatior the pub surance standan

Refere

1 Lind in th

2 Porn in th 3(4 S

3 Se ti uial 2000

4 Bette esthe mell t

S Pract Anc Ane Ane

6 http menl

7 W Ori

a ne 1994

8 http1 htm

9 Pow menl

10 Wort

dorn~

Arne 1994

11 Lo~ guid line

12 Wort rt ec

13 Aldn 1970

14 Kun form LapG

IS Bem term hi po

63 2013 1I1T(1II101l el al Office-based Hysleroscopic Surgery

xIth state and federal Drug Enforcement Agency regulations 16 Emanuel MH Wamsteke r K The intrauterine morcellator a new hys shyteroscopic operating technique to remove intrauterine polyps and myoshy

Ii imperative In addition physicians are urged to adhere to mas J Minim Invasive Gynecol 2005 1262-66

savings to h~ guidelines set forth by the ACOG [32] and to consider 17 Papalampros P Gambadauro P Papadopoulos N et al The minishy

r icipation in the ACOG Safety Certification in Outpatientprefer the fashy resectoscope a new instrument for office hysteroscopic surgery Acta

the physishy IlJctice Excellence (SCOPE) for Women [36] Although Obslet Gynecol Scand 200988227-230

more efficient most states do not demand formal accreditation [35] for 18 Indman PD Office hysteroscopy In Cohen SM editor Operative Lapshyaroscopy and Hysteroscopy New York Churchill Livingstone 1996 wilh 08S the imprimatur of one of the major accreditation orgashyp239-250malions along with the ACOG SCOPE program provides

19 Connor VF Essure a review six years later J Minim II1(yive Gynecol thepublic and the professional staff with a measure of reasshy 200916282-290 urance and confidence that the facility has adhered to a high 20 Cicinelli E Hysteroscopy without anesthesia review of recent literashy

IJndard of clinical care ture J Minim In vasive Gynecology 2010 17703-708 21 Lau WC Lo WK Tam WH Yuen PM Paracervical anesthesia in outshy

References patient hysteroscopy a randomized double-blind placebo-controlledexperishy trial Br J Obstet Gynecol 1999 106356-359

ps in an OBS Lindheim SR Kavic S Shulman SV Sauer MY Operative hysteroscopy 22 Lopes P Giobon E Linet T Phillipe HJ Hysteroscopic tubal sterilizashy

nt electrodes in the office setti ng JAm Assoc Gynecol Laparosc 2000765- 69 tion with Essure intratubal devices a case-control prospective with inert Porreca MR Pansini N Bettocchi S et al Hysteroscopic polypectomy local anesthesia or without anesthesia Eur J Obstet Gynecol Reprod

in the office without anesthesia JAm Assoc Gynecol Laparosc 1996 Bioi 2008 138 199-203 )(4 Suppl)S40 23 Vercellini P Colombo A Mauro F et al Paracervical anesthesia for

Sesti F Marl iali N Santomarco N Hysteroscopic surgery for endomeshy outpatient hystcroscopy Fertil Sleril 199462 1083- 1085 tria l polyps using a bipolar microelectrode Int J Gynaecol Obstet 24 Munro MG Brooks PG Use of loca l anesthesia for office diagnostic ~OOO7 1283- 284 and operative hysteroscopy J Minim Invasi ve Gynecol 201017

- Bettocchi S Ceci 0 Nappi L et al Operative hysteroscopy without anshy 709- 718 elhesia analysis of 4863 cases performed with mechanical instrushy 25 Nagele F OConnor H Davies A et ai 2500 Outpatient diagnostic hysshyment JAm Assoc Gynecol 2004 II 59-61 teroscopies Obstet Gynecol 1996 8887-92

Prac tice Guidelines for Sedation and Analgesia by Nonshy 26 Mercorio F DeSimone R Landi P et al Oral dexketoprofen for pain Anesthesiologists an updated report by the American Society of treatment during diagnostic hysteroscopy in postmenopausal women nestheSiologists Task Force on Sedation and Analgesia by Nonshy Mawritas 2002 10277-28 1 nesthesiologist s Aneslhesiology 200296 1004-1017 27 Raffaele R Lanzone A Tagliaferri V et al Using a 16-French resecto shyRllplwwwnsahqorgFor-MemhersS tandards-Guidel ines-and-S tate scope as an alternative dev ice in the treatment of uterine lesions a ranshyl_ntsaspx Accessed August 12 20 I 2 domized controlled trial Obstet Gynecnl 2012 120 160-165 lIortman M Daggett A Hysteroscopic endomyometrial resection 28 Bettocchi S Nappi L Ccei 0 Selvaggi L What does diagnostic

the existence ~ nell technique for the treatment of menorrhagia Obstet Gynecol hysteroscopy mean today the role of the new techniques Curr

managed with 199482295-298 Opin Obslet Gynecol 2003 15303-308 bllpllwlVwhealthnygovprofessionalsoffice-based_surgerylaw230-d 29 Glasser MH Practical tips for office hysteroscopy and secondshyto provide him Acce~sed Jul y 5 2012 generation global endometrial ablation J Minim Invasive Gynecol perf rming adshy~Oiel SM Hill RK My copilot is a nurse using crew resource manageshy 2009 16384-399 ment in the OR AORN J 200683 179-180 30 Renner RM Jensen JT Nichol MD Edelman AB Pain control in firstshyWortman M Daggett Serum sodium changes during hysteroscopic enshy trimester surgical abortion a systematic rcvicw of randomized conshyilnt)ornetrial resection Paper presented at 23rd Annual Meeting of the trolled trial s Contraception 2010 8 1 372-388 merican Association of Gynecologic Laparoscopists October 18-24 31 Allen R Fortin J Bartz 0 et al Womens preferences for pain control 199 New York NY during first-trimester surgical abortion a qualitative study ContracepshyLoffer FD Bradley LP Brill AI et al Hysteroscopic fluid monitoring liol 20 1285413-418 roidd ines from the Ad Hoc Committee on Hysteroscopic Fluid Guideshy 32 Erickson TB Kirkpatrick DH DeFrancesco MS Executive Summary lines of the AAGL JAm Assoc Gynecol Laparosc 20007 I 67-168 of the American College of Obstetricians and Gynecologists Presidenshynman M Sonographically-guided hysteroscopic endomyometrial tial Task Force on Patient Safety in the Office Setting reinvigorating Ttlion Surg Tech IIlII 201221163-169 safety in office-based gynecologic surgery Obstet Gynecol 20 10

Aldrcte JA Kroulik D A post anesthetic recovery score Anesth Analg 115147-151 19i049924--933 33 Wortman M Daggett A Hysteroscopic endomyometrial resection

and proven unpound Re Vilos GA Thomas B et al A new bipolar system for pershy JSLS 20004 197-207 sedatives and lllmng operative hysteroscopy in normal saline JAm Assoc Gynecol 34 Wortman M Instituting an office-based surgery program in the gyneshy

fellowship proshy UJflllrosC 19993331 -336 cologists office J Minim In vllsive Gynecol 201017673-683 gelloccbi S Ceci 0 DiVenere R et al Advanced operative office hysshy 35 httpwww fsm b orgpd fIgrpo l_regulation_office_based_surgery pdf and extensive tregscopy without anesthesia analysis of 50 I cases treated with a 5 Fr Accessed August 12 20J 2lenges of providshy

rolar electrode Hum Reprod 2002 172435-2438 36 httpwwwscopeforwomenshealthorg Accessed August 152012 office setting ical boards to

ments for officeshya [3435] In the compliance with

Page 5: lVorrml1 OF...Patients: Women undergoing operative hysteroscopy in an office setting, Interventions: Three hundred eighty-seven women underwent a total of 414 operative hysteroscopic

J

60 Journal of Minimally fnvasive Gynecology Vol 20 No JanuaryFebrtliln 211

Table 2

Indication for procedure

Procedure

Menorrhagia

Metorrhagia

Menometorrhagia

Pain

Menorrhagia with pain

Metorrhagia with pain

Hypermenorrhea

Thickened endometrium

Postmenopausal bleeding

Infertility

No of indications

136

3

21

54

128

6

31

17

15

3

There were 11 complications (2700) Eight women (1900) developed infections within the first 36 hours most became febrile within 30 minutes after the procedure and were given parenteral antibiotic therapy None of the infecshytious complications required hospitalization One uterine perforation (0200) occurred with an active electrode requirshying a hospital transfer and diagnostic laparoscopy no visshyceral injury was sustained and the patient was discharged after 48 hours of observation Two uterine ruptures occurred which precluded completion of the procedure Nine addishytional uterine ruptures transpired which neither altered the postoperative course nor precluded completion of the proceshydure In all 9 cases the uterine defect was first noted because of a rapid increase in the patients fluid deficit These defects were generally estimated to be lt5 mm Uterine rupture was differentiated from perforation by careful and immediate reshyview of the digital video recording to determine whether a deshyvice had passed through the uterine serosa In all instances the rupture occurred at the fundus just medial to the midline no ruptures occurred at the cornua Ten women (2400) in whom bleeding exceeded I gmin required uterine tamposhynade using a Foley catheter The catheter was kept in place for 45 minutes to 2 hours before discharge from the office

No complications were attributable to use of any parenshyterally administered analgesics or sedatives Although transhysient mild hypoxemia (oxygen saturation concentration in hemoglobin 8000-9000) did occur such incidents responded quickly to supplemental oxygen in combination with verbal and tactile stimulation In no instances was the use of nalox-

Tissue weight by procedure type

Procedure

EMR

Myomectomy

Repeat operative EMR

EMR = endomyometrial resection

Mean (SD) g Range g

119 (59) 08-380

203 (126) 19-770

75 (60) 1- 380

Table 4

Hi stologic findings

Variable No of findinSI

Normal endo metrium 349

Endometrial polyp 51

Normal myometrium 259 Leiomyoma 149

Complex hyperplasia 4

Adenomyosis 79

one or f1umazenil required There were no instances ofva~

vagal reactions A total of 255 women responded to our telephone sum~

Patients who underwent more than a single procedure durin the study were asked to respond separately for eaGh procemiddot dure Of the 11 women who experienced complications completed the survey representing 3500 of the total respolJshydents Two hundred ten (82400) were very satisfied (95t

confidence interval [CI] 1l9400 to 2l06) and ~~

(16500) were satisfied (9500 CI 1194 to 21061 with the procedure Three women (12) were somewhil dissatisfied (9500 CI -014 to 25400) I because sh thought she had been inadequately sedated and 2 becau( of prolonged nausea and vomiting after the procedure Two hundred forty-nine respondents (976) expressamp preference for an office-based procedure (9500 CI 95 2 to 994500) and only 6 women (2400) (9500 CI[052~ I~ 428) would have preferred a hospital setting Of the D women 1 believed she had been inadequately sedated experienced severe nausea and 3 others (all regjsterc~

nurses) simply explained that they would have been more comfortable in a hospital setting but cited no specific H ciencies Two hundred forty-nine women (980) (9- CI 962800 to 997200) stated they would recommend Ih procedure to a friend Of the 5 who would not recommeru the procedure to a friend 3 women already noted abolt explained that they would have felt more comfortable In

a hospital setting and 2 women stated that they had hopoJ for a better surgical outcome

Discussion

Until the 1990s the role of office-based hysteroscopy 1

limited to its use as a diagnostic tool The introduction of

small-diameter continuous-flow hysteroscopes with ded cated working channels designed to accommodate operatl instruments made it possible for several ground-breakin surgeons [1-4J to treat some uterine and cervical djsea~ middot

in the office setting without cervical dilation thereh avoiding the use of general anesthesia

In 1999 Kung et al [l4J reported the treatment resul t ia 10 women with symptomatic submucous leiomyomas en(jo metria I polyps uterine septae and intrauterine synechiae 1

Wortman

a pilot sl ranging electrod setting ported a office-be perform tal analg rangmg varying

In 20 use of a I copy 1m and subr required removal tor (Smi System ( mately 6 terns ha no large acceptab

More of a 16F going ex cous lei( procedur none req

As tee logic pro office th OBS sett strument Occillsior and can the use ( Notwiths noted tha even wit~ can secti pausal s~

The limit block [24 been doci not obvia [271 Exp while pro siblebutr iss ues in

The e~ most patil 5 to 6 mn of small are comp Bettocchi generaUy

61 nmall et ai Office-based Hysteroscopic Surgery

No of findings

349

51

259

149

4

79

total responshysfied (95

) and 42 to 2106)

the procedure ) expressed CI9572

CI[O52 to tting Of the 6

y edated 2 (all registered ve been more specific defi shy

(980) (95

comfortable in they had hoped

ysteroscopy was introduction of

with dedishy

i pilot study using a variety of small-diameter hysteroscopes mging from l5F to 2lF and 5F Versapoint (Ethicon Inc) t~ctrodes the potential for using this system in an office dling was thus established In 2002 Bettocchi et al [15] reshyfIl rted an observational study of 501 women who underwent office-based treatment of benign intrauterine disease largely [(rformed using the Versapoint system without supplemenshyl analgesia or anesthesia In that study endometrial polyps mUng from 05 to 45 cm and submucous leiomyomas ar ing from 06 to 20 cm were removed

In 2005 Emanuel and Wamsteker [16] first reported the Lr of a hysteroscopic morcellator (Smith amp Nephew Endosshy opy Inc Andover MA) for removal of endometrial polyps d submucous leiomyomas Although the original device

elJuired a 9-mm operative sheath 2 small-diameter tissue moal systems the Truclear 50 Hysteroscopic Morcellashyr (Smith amp Nephew) and the MyoSure Tissue Removal

l)stem (Hologic Inc) are now available in sizes approxishyately 6 mm in diameter While these small-diameter sysshy~s have been designed for office use there are currently

large series that address either their efficacy or patient ceptability in an OBS setting

Iore recently Papalampros et al [17] reported the use a 16F continuous-flow resectoscope in 30 patients undershy

ving excision of polyps ranging from I to 5 cm and submushyJlIS leiomyomas varying from 2 to 3 cm Most of the lOCedures were performed in an outpatient clinic and

ne required more than intracervical anesthesia As technology facilitates the migration of many gynecoshy

middotg ie procedures from the ambulatory surgery center to the fice the limits of what can be reasonably achieved in an ]5 setting is expanding Small-diameter hysteroscopy inshyJrUments have proved their efficacy for diagnosis [18] tubal

lusion [19] and even removal of endometrial polyps l carefully selected myomas [415] often without use of anesthetic blocks or analgesics and sedatives Jrwithstanding these technologic advances Cicinelli [20] ledthat severe pain and adverse effects may occur rarely 11 with mini-instruments Women with a history of cesarshy

section chronic pelvic pain or anxiety or are menoshylIlSal should be considered at risk of pain perception

o limitations of paracervical block [21-23] intracervical -k [2425] and orally administered analgesics [26] have

-En documented Even careful patient selection criteria do obviate vasovagal reactions and moderate surgical pain

IIExpansion of operative hysteroscopy in an OBS setting hlle providing safety and comfort to patients is clearly feashyIe but requires a paradigm shift in thinking about 2 critical middotUes instrumentation and sedation and analgesia The exclusive reliance on small-diameter instruments in

] patients must be questioned Instruments smaller than u6 mm in diameter though well suited for management ~mall polyps leiomyomas and intrauterine synechiae comparatively inefficient for excision of lesionsgt 3 cm tocchi et al [28] observed that the internal cervical orifice ~erally varies from 4 to 5 mm in nulliparous women and

7 to 8 mm in mUltiparous women Given this wide anatomic variation it seems reasonable to conclude that larger instrushyments may be appropriate at least in some circumstances It is worth noting that 2 commonly used endometrial ablation devices the HydroThermAblator System (Boston Scientific Corp Marlborough MA) and the NovaSure (Hologic Inc) use an 8-mm and a 72-mm outside diameter appliance respectively [29] Given that both devices enjoy widespread use in the OBS setting it seems reasonable that hysteroshyscopes of similar diameter should be given greater considershyation for office use The present study demonstrates that 26F and 22F resectoscopes are well tolerated in an office setting in particular with preparatory use of laminaria

It may be argued that our specialty has not embraced the expansion of analgesic and sedation regimens nearly as much as it has welcomed new technology Much of what we know about analgesia and sedation for OBS procedures is derived from studies of pain control during first-trimester surgical abortions [30] The sedation and analgesic regimens that have been studied in women undergoing surgical aborshytion have little applicability in women undergoing hysteroshyscopic surgery a group who are generally older and in whom procedures are lengthier However a recent study of womens preferences for pain control during first-trimester surgical abortion [31] confirms what the ACOG guidelines for office-based surgery [32] already suggest that women feel that pain control decisions should be individualized

Advanced hysteroscopic surgery including endomyomeshytrial resection and removal of polyps septae and all grades of submucous and even intramuralleiomyomas is clearly feasishyble in an OBS setting Even myomas as large as 6 cm and specimens weighing up to 77 g can be safely removed with proper instrumentation sonographic guidance and adequate analgesia and sedation However the safety and high rate of patient satisfaction that we observed is the result of a dedicated and experienced operating room team working toshygether and developing collective knowledge and experience Although we can conclude that the use of small incremental dosages of opiates and sedatives is safe in our particular setshyting it is worth noting that the adoption of advanced operative hysteroscopy came only after mastering these techniques in the controlled environment of an ambulatory surgical center and after many thousands of diagnostic hysteroscopies were performed in the OBS setting with adjuvant use of moderate conscious sedation

The complications that we most commonly observed were infections and uterine rupture The infections likely resulted from the combination of laminaria followed by denudation of the entire endomyometrium Uterine rupture is likely the consequence of using high pump pressures while aggresshysively reducing myometrial thickness during the course of endomyometrial resection Ruptures typically occur at the apex of the uterus just after the electrosurgicalloop is swept across the fundus These defects tend to occur between the midline and the cornua Two important predisposing factors seem to be the presence of a fundal leiomyoma and

l

(

62 Journal ofMinimally Invasive Gynecology Vol 20 No 1 JanuoryFebruary 2013 W Oflll1GIl

a muscular layer lt I cm in thickness as distention occurs Pashytients who experience uterine rupture do not seem to note increased pain during or immediately after the procedure

The present study does not include long-term outcomes however it is worth noting that in women who underwent endomyometrial resection without myomectomy the avershyage specimen weight of 119 g compares favorably with our (MW and AD) previous series that was performed with the patients under general anesthesia [33]

The limitations of the present study include its retrospecshytive nature and that telephone surveys are prone to some elshyement of selection bias inasmuch as dissatisfied patients are less likely to respond Surveys performed at varying intershyvals after the original procedure are likely to be less accurate than surveys conducted within a standardized interval such as 24 to 72 hours after completion Another limiting factor of the present study is that women who experience favorable menstrual outcomes are more apt to report greater rates of satisfaction with office-based surgery Additional studies will be necessary to determine whether the rates of repeat operation in women undergoing office-based hysteroscopic surgery are comparable with those that we have reported in a hospital or ambulatory surgical center setting [33]

Gynecologists considering incorporation of operative hysteroscopy into an OBS setting must carefully consider the costs of initiating such a program Expenses will vary with local regulatory and state medical board requirements equipment that is already available to the practitioner and whether used or new instruments are purchased Many offices may already own much of the necessary paraphernashylia such as an office-appropriate operating room table an electrosurgical generator a video camera with monitor an ultrasound machine and an emergency cart Fluid manageshyment systems and resectoscopes can often be purchased from companies specializing in used medical equipment at a fraction of the cost of their newer models The importance of redundant equipment in particular a second resectoscope cannot be overstated In the final analysis one must consider the expected patient volume and start-up costs before investshying substantial time and resources

Finally one must consider that the benefits to the physishycian are maximized when OBS blends well into the daily pashytient flow of ones practice We find it most useful to schedule operative hysteroscopic procedures as the first case in either the morning or afternoon session Although we have accommodated as many as 6 operative hysteroshyscopic procedures in a week we believe that 1 or 2 proceshydures per week is sufficient for the physician to derive the benefits of OBS while enabling the operating room crew to develop and maintain the necessary skills required for pashytient safety

Conclusions

The advantages of office-based hysteroscopic surgery are 4-fold First it often enables the gynecologist to combine the

diagnostic and treatment phases of patient management obshyviating the need for multiple interventions and anesthetics Second this approach produces substantial cost savings to the insurer and the patient Third many women prefer the fashymiliar environment of the office setting Fourth the physishycian benefits from the ease of scheduling more efficient use of time and improved reimbursement compared with hospital- or ambulatory surgical center-based procedures

There are 2 advantages of a large-diameter resectoscope its efficiency and adaptability to a variety of concomitant procedures It is particularly efficient in removing large quantities of tissue that is not possible with smaller instrushyments Bettocchi et al [15] who have considerable experishyence in removal of leiomyomas and polyps in an OBS setting note that the use of the SF Versapoint electrodes to treat these larger myomas (greater than 2 cm) is time conshysuming and yields lower quality final results In addition the larger-diameter resectoscope is adaptable to all types of hysteroscopic procedures including endomyometrial reshysection polypectomy myomectomy and repeat operative hysteroscopy in many cases 2 of more of these procedures are required in the same patient The use of a single instrushyment obviates the need for multiple specialized instruments such as a nonresectoscopic endometrial ablation device combined with a resectoscope or tissue morcellation apparashytus for management of menorrhagia in a woman with a modshyerately sized submucous leiomyoma

The limitations on hysteroscopic surgery in an OBS setshyting are 3-fold operator skill and experience the existence of intrauterine disease beyond what can be managed with a small-diameter hysteroscope and the capacity to provide patient comfort Patient comfort is critical in performing adshyvanced office-based procedures

We have demonstrated that a large-diameter resectoscope can be safely used in a properly equipped and accredited ofshyfice by a physician working with a dedicated and motivated operating room team However patient satisfaction requires careful consideration of her need for analgesia and sedation

The influx of numerous technologic innovations in the past 2 decades has increased the range of what is possible in an office setting The continued advancement of officeshybased surgery however will depend not only on new technolshyogy but on development of safe effective and proven protocols for administration of adequate sedatives and analgesics in the OBS setting Residency and fellowship proshygrams are encouraged to provide the necessary and extensive training indispensible for managing the challenges of providshying appropriate analgesia and sedation in the office setting

Physicians must consult their state medical boards to meet any formal accreditation requirements Failure to comshyply with regulatory requirements may be grounds for license revocation It is worth noting that as of this writing only 9 states required accreditation once various thresholds have been crossed 25 states have no requirements for officeshybased surgery or office-based anesthesia [3435] In the absence of state regulations for OBS compliance with

both sta IS Impe the gui( particip Practic( most st OBS tf nizatior the pub surance standan

Refere

1 Lind in th

2 Porn in th 3(4 S

3 Se ti uial 2000

4 Bette esthe mell t

S Pract Anc Ane Ane

6 http menl

7 W Ori

a ne 1994

8 http1 htm

9 Pow menl

10 Wort

dorn~

Arne 1994

11 Lo~ guid line

12 Wort rt ec

13 Aldn 1970

14 Kun form LapG

IS Bem term hi po

63 2013 1I1T(1II101l el al Office-based Hysleroscopic Surgery

xIth state and federal Drug Enforcement Agency regulations 16 Emanuel MH Wamsteke r K The intrauterine morcellator a new hys shyteroscopic operating technique to remove intrauterine polyps and myoshy

Ii imperative In addition physicians are urged to adhere to mas J Minim Invasive Gynecol 2005 1262-66

savings to h~ guidelines set forth by the ACOG [32] and to consider 17 Papalampros P Gambadauro P Papadopoulos N et al The minishy

r icipation in the ACOG Safety Certification in Outpatientprefer the fashy resectoscope a new instrument for office hysteroscopic surgery Acta

the physishy IlJctice Excellence (SCOPE) for Women [36] Although Obslet Gynecol Scand 200988227-230

more efficient most states do not demand formal accreditation [35] for 18 Indman PD Office hysteroscopy In Cohen SM editor Operative Lapshyaroscopy and Hysteroscopy New York Churchill Livingstone 1996 wilh 08S the imprimatur of one of the major accreditation orgashyp239-250malions along with the ACOG SCOPE program provides

19 Connor VF Essure a review six years later J Minim II1(yive Gynecol thepublic and the professional staff with a measure of reasshy 200916282-290 urance and confidence that the facility has adhered to a high 20 Cicinelli E Hysteroscopy without anesthesia review of recent literashy

IJndard of clinical care ture J Minim In vasive Gynecology 2010 17703-708 21 Lau WC Lo WK Tam WH Yuen PM Paracervical anesthesia in outshy

References patient hysteroscopy a randomized double-blind placebo-controlledexperishy trial Br J Obstet Gynecol 1999 106356-359

ps in an OBS Lindheim SR Kavic S Shulman SV Sauer MY Operative hysteroscopy 22 Lopes P Giobon E Linet T Phillipe HJ Hysteroscopic tubal sterilizashy

nt electrodes in the office setti ng JAm Assoc Gynecol Laparosc 2000765- 69 tion with Essure intratubal devices a case-control prospective with inert Porreca MR Pansini N Bettocchi S et al Hysteroscopic polypectomy local anesthesia or without anesthesia Eur J Obstet Gynecol Reprod

in the office without anesthesia JAm Assoc Gynecol Laparosc 1996 Bioi 2008 138 199-203 )(4 Suppl)S40 23 Vercellini P Colombo A Mauro F et al Paracervical anesthesia for

Sesti F Marl iali N Santomarco N Hysteroscopic surgery for endomeshy outpatient hystcroscopy Fertil Sleril 199462 1083- 1085 tria l polyps using a bipolar microelectrode Int J Gynaecol Obstet 24 Munro MG Brooks PG Use of loca l anesthesia for office diagnostic ~OOO7 1283- 284 and operative hysteroscopy J Minim Invasi ve Gynecol 201017

- Bettocchi S Ceci 0 Nappi L et al Operative hysteroscopy without anshy 709- 718 elhesia analysis of 4863 cases performed with mechanical instrushy 25 Nagele F OConnor H Davies A et ai 2500 Outpatient diagnostic hysshyment JAm Assoc Gynecol 2004 II 59-61 teroscopies Obstet Gynecol 1996 8887-92

Prac tice Guidelines for Sedation and Analgesia by Nonshy 26 Mercorio F DeSimone R Landi P et al Oral dexketoprofen for pain Anesthesiologists an updated report by the American Society of treatment during diagnostic hysteroscopy in postmenopausal women nestheSiologists Task Force on Sedation and Analgesia by Nonshy Mawritas 2002 10277-28 1 nesthesiologist s Aneslhesiology 200296 1004-1017 27 Raffaele R Lanzone A Tagliaferri V et al Using a 16-French resecto shyRllplwwwnsahqorgFor-MemhersS tandards-Guidel ines-and-S tate scope as an alternative dev ice in the treatment of uterine lesions a ranshyl_ntsaspx Accessed August 12 20 I 2 domized controlled trial Obstet Gynecnl 2012 120 160-165 lIortman M Daggett A Hysteroscopic endomyometrial resection 28 Bettocchi S Nappi L Ccei 0 Selvaggi L What does diagnostic

the existence ~ nell technique for the treatment of menorrhagia Obstet Gynecol hysteroscopy mean today the role of the new techniques Curr

managed with 199482295-298 Opin Obslet Gynecol 2003 15303-308 bllpllwlVwhealthnygovprofessionalsoffice-based_surgerylaw230-d 29 Glasser MH Practical tips for office hysteroscopy and secondshyto provide him Acce~sed Jul y 5 2012 generation global endometrial ablation J Minim Invasive Gynecol perf rming adshy~Oiel SM Hill RK My copilot is a nurse using crew resource manageshy 2009 16384-399 ment in the OR AORN J 200683 179-180 30 Renner RM Jensen JT Nichol MD Edelman AB Pain control in firstshyWortman M Daggett Serum sodium changes during hysteroscopic enshy trimester surgical abortion a systematic rcvicw of randomized conshyilnt)ornetrial resection Paper presented at 23rd Annual Meeting of the trolled trial s Contraception 2010 8 1 372-388 merican Association of Gynecologic Laparoscopists October 18-24 31 Allen R Fortin J Bartz 0 et al Womens preferences for pain control 199 New York NY during first-trimester surgical abortion a qualitative study ContracepshyLoffer FD Bradley LP Brill AI et al Hysteroscopic fluid monitoring liol 20 1285413-418 roidd ines from the Ad Hoc Committee on Hysteroscopic Fluid Guideshy 32 Erickson TB Kirkpatrick DH DeFrancesco MS Executive Summary lines of the AAGL JAm Assoc Gynecol Laparosc 20007 I 67-168 of the American College of Obstetricians and Gynecologists Presidenshynman M Sonographically-guided hysteroscopic endomyometrial tial Task Force on Patient Safety in the Office Setting reinvigorating Ttlion Surg Tech IIlII 201221163-169 safety in office-based gynecologic surgery Obstet Gynecol 20 10

Aldrcte JA Kroulik D A post anesthetic recovery score Anesth Analg 115147-151 19i049924--933 33 Wortman M Daggett A Hysteroscopic endomyometrial resection

and proven unpound Re Vilos GA Thomas B et al A new bipolar system for pershy JSLS 20004 197-207 sedatives and lllmng operative hysteroscopy in normal saline JAm Assoc Gynecol 34 Wortman M Instituting an office-based surgery program in the gyneshy

fellowship proshy UJflllrosC 19993331 -336 cologists office J Minim In vllsive Gynecol 201017673-683 gelloccbi S Ceci 0 DiVenere R et al Advanced operative office hysshy 35 httpwww fsm b orgpd fIgrpo l_regulation_office_based_surgery pdf and extensive tregscopy without anesthesia analysis of 50 I cases treated with a 5 Fr Accessed August 12 20J 2lenges of providshy

rolar electrode Hum Reprod 2002 172435-2438 36 httpwwwscopeforwomenshealthorg Accessed August 152012 office setting ical boards to

ments for officeshya [3435] In the compliance with

Page 6: lVorrml1 OF...Patients: Women undergoing operative hysteroscopy in an office setting, Interventions: Three hundred eighty-seven women underwent a total of 414 operative hysteroscopic

61 nmall et ai Office-based Hysteroscopic Surgery

No of findings

349

51

259

149

4

79

total responshysfied (95

) and 42 to 2106)

the procedure ) expressed CI9572

CI[O52 to tting Of the 6

y edated 2 (all registered ve been more specific defi shy

(980) (95

comfortable in they had hoped

ysteroscopy was introduction of

with dedishy

i pilot study using a variety of small-diameter hysteroscopes mging from l5F to 2lF and 5F Versapoint (Ethicon Inc) t~ctrodes the potential for using this system in an office dling was thus established In 2002 Bettocchi et al [15] reshyfIl rted an observational study of 501 women who underwent office-based treatment of benign intrauterine disease largely [(rformed using the Versapoint system without supplemenshyl analgesia or anesthesia In that study endometrial polyps mUng from 05 to 45 cm and submucous leiomyomas ar ing from 06 to 20 cm were removed

In 2005 Emanuel and Wamsteker [16] first reported the Lr of a hysteroscopic morcellator (Smith amp Nephew Endosshy opy Inc Andover MA) for removal of endometrial polyps d submucous leiomyomas Although the original device

elJuired a 9-mm operative sheath 2 small-diameter tissue moal systems the Truclear 50 Hysteroscopic Morcellashyr (Smith amp Nephew) and the MyoSure Tissue Removal

l)stem (Hologic Inc) are now available in sizes approxishyately 6 mm in diameter While these small-diameter sysshy~s have been designed for office use there are currently

large series that address either their efficacy or patient ceptability in an OBS setting

Iore recently Papalampros et al [17] reported the use a 16F continuous-flow resectoscope in 30 patients undershy

ving excision of polyps ranging from I to 5 cm and submushyJlIS leiomyomas varying from 2 to 3 cm Most of the lOCedures were performed in an outpatient clinic and

ne required more than intracervical anesthesia As technology facilitates the migration of many gynecoshy

middotg ie procedures from the ambulatory surgery center to the fice the limits of what can be reasonably achieved in an ]5 setting is expanding Small-diameter hysteroscopy inshyJrUments have proved their efficacy for diagnosis [18] tubal

lusion [19] and even removal of endometrial polyps l carefully selected myomas [415] often without use of anesthetic blocks or analgesics and sedatives Jrwithstanding these technologic advances Cicinelli [20] ledthat severe pain and adverse effects may occur rarely 11 with mini-instruments Women with a history of cesarshy

section chronic pelvic pain or anxiety or are menoshylIlSal should be considered at risk of pain perception

o limitations of paracervical block [21-23] intracervical -k [2425] and orally administered analgesics [26] have

-En documented Even careful patient selection criteria do obviate vasovagal reactions and moderate surgical pain

IIExpansion of operative hysteroscopy in an OBS setting hlle providing safety and comfort to patients is clearly feashyIe but requires a paradigm shift in thinking about 2 critical middotUes instrumentation and sedation and analgesia The exclusive reliance on small-diameter instruments in

] patients must be questioned Instruments smaller than u6 mm in diameter though well suited for management ~mall polyps leiomyomas and intrauterine synechiae comparatively inefficient for excision of lesionsgt 3 cm tocchi et al [28] observed that the internal cervical orifice ~erally varies from 4 to 5 mm in nulliparous women and

7 to 8 mm in mUltiparous women Given this wide anatomic variation it seems reasonable to conclude that larger instrushyments may be appropriate at least in some circumstances It is worth noting that 2 commonly used endometrial ablation devices the HydroThermAblator System (Boston Scientific Corp Marlborough MA) and the NovaSure (Hologic Inc) use an 8-mm and a 72-mm outside diameter appliance respectively [29] Given that both devices enjoy widespread use in the OBS setting it seems reasonable that hysteroshyscopes of similar diameter should be given greater considershyation for office use The present study demonstrates that 26F and 22F resectoscopes are well tolerated in an office setting in particular with preparatory use of laminaria

It may be argued that our specialty has not embraced the expansion of analgesic and sedation regimens nearly as much as it has welcomed new technology Much of what we know about analgesia and sedation for OBS procedures is derived from studies of pain control during first-trimester surgical abortions [30] The sedation and analgesic regimens that have been studied in women undergoing surgical aborshytion have little applicability in women undergoing hysteroshyscopic surgery a group who are generally older and in whom procedures are lengthier However a recent study of womens preferences for pain control during first-trimester surgical abortion [31] confirms what the ACOG guidelines for office-based surgery [32] already suggest that women feel that pain control decisions should be individualized

Advanced hysteroscopic surgery including endomyomeshytrial resection and removal of polyps septae and all grades of submucous and even intramuralleiomyomas is clearly feasishyble in an OBS setting Even myomas as large as 6 cm and specimens weighing up to 77 g can be safely removed with proper instrumentation sonographic guidance and adequate analgesia and sedation However the safety and high rate of patient satisfaction that we observed is the result of a dedicated and experienced operating room team working toshygether and developing collective knowledge and experience Although we can conclude that the use of small incremental dosages of opiates and sedatives is safe in our particular setshyting it is worth noting that the adoption of advanced operative hysteroscopy came only after mastering these techniques in the controlled environment of an ambulatory surgical center and after many thousands of diagnostic hysteroscopies were performed in the OBS setting with adjuvant use of moderate conscious sedation

The complications that we most commonly observed were infections and uterine rupture The infections likely resulted from the combination of laminaria followed by denudation of the entire endomyometrium Uterine rupture is likely the consequence of using high pump pressures while aggresshysively reducing myometrial thickness during the course of endomyometrial resection Ruptures typically occur at the apex of the uterus just after the electrosurgicalloop is swept across the fundus These defects tend to occur between the midline and the cornua Two important predisposing factors seem to be the presence of a fundal leiomyoma and

l

(

62 Journal ofMinimally Invasive Gynecology Vol 20 No 1 JanuoryFebruary 2013 W Oflll1GIl

a muscular layer lt I cm in thickness as distention occurs Pashytients who experience uterine rupture do not seem to note increased pain during or immediately after the procedure

The present study does not include long-term outcomes however it is worth noting that in women who underwent endomyometrial resection without myomectomy the avershyage specimen weight of 119 g compares favorably with our (MW and AD) previous series that was performed with the patients under general anesthesia [33]

The limitations of the present study include its retrospecshytive nature and that telephone surveys are prone to some elshyement of selection bias inasmuch as dissatisfied patients are less likely to respond Surveys performed at varying intershyvals after the original procedure are likely to be less accurate than surveys conducted within a standardized interval such as 24 to 72 hours after completion Another limiting factor of the present study is that women who experience favorable menstrual outcomes are more apt to report greater rates of satisfaction with office-based surgery Additional studies will be necessary to determine whether the rates of repeat operation in women undergoing office-based hysteroscopic surgery are comparable with those that we have reported in a hospital or ambulatory surgical center setting [33]

Gynecologists considering incorporation of operative hysteroscopy into an OBS setting must carefully consider the costs of initiating such a program Expenses will vary with local regulatory and state medical board requirements equipment that is already available to the practitioner and whether used or new instruments are purchased Many offices may already own much of the necessary paraphernashylia such as an office-appropriate operating room table an electrosurgical generator a video camera with monitor an ultrasound machine and an emergency cart Fluid manageshyment systems and resectoscopes can often be purchased from companies specializing in used medical equipment at a fraction of the cost of their newer models The importance of redundant equipment in particular a second resectoscope cannot be overstated In the final analysis one must consider the expected patient volume and start-up costs before investshying substantial time and resources

Finally one must consider that the benefits to the physishycian are maximized when OBS blends well into the daily pashytient flow of ones practice We find it most useful to schedule operative hysteroscopic procedures as the first case in either the morning or afternoon session Although we have accommodated as many as 6 operative hysteroshyscopic procedures in a week we believe that 1 or 2 proceshydures per week is sufficient for the physician to derive the benefits of OBS while enabling the operating room crew to develop and maintain the necessary skills required for pashytient safety

Conclusions

The advantages of office-based hysteroscopic surgery are 4-fold First it often enables the gynecologist to combine the

diagnostic and treatment phases of patient management obshyviating the need for multiple interventions and anesthetics Second this approach produces substantial cost savings to the insurer and the patient Third many women prefer the fashymiliar environment of the office setting Fourth the physishycian benefits from the ease of scheduling more efficient use of time and improved reimbursement compared with hospital- or ambulatory surgical center-based procedures

There are 2 advantages of a large-diameter resectoscope its efficiency and adaptability to a variety of concomitant procedures It is particularly efficient in removing large quantities of tissue that is not possible with smaller instrushyments Bettocchi et al [15] who have considerable experishyence in removal of leiomyomas and polyps in an OBS setting note that the use of the SF Versapoint electrodes to treat these larger myomas (greater than 2 cm) is time conshysuming and yields lower quality final results In addition the larger-diameter resectoscope is adaptable to all types of hysteroscopic procedures including endomyometrial reshysection polypectomy myomectomy and repeat operative hysteroscopy in many cases 2 of more of these procedures are required in the same patient The use of a single instrushyment obviates the need for multiple specialized instruments such as a nonresectoscopic endometrial ablation device combined with a resectoscope or tissue morcellation apparashytus for management of menorrhagia in a woman with a modshyerately sized submucous leiomyoma

The limitations on hysteroscopic surgery in an OBS setshyting are 3-fold operator skill and experience the existence of intrauterine disease beyond what can be managed with a small-diameter hysteroscope and the capacity to provide patient comfort Patient comfort is critical in performing adshyvanced office-based procedures

We have demonstrated that a large-diameter resectoscope can be safely used in a properly equipped and accredited ofshyfice by a physician working with a dedicated and motivated operating room team However patient satisfaction requires careful consideration of her need for analgesia and sedation

The influx of numerous technologic innovations in the past 2 decades has increased the range of what is possible in an office setting The continued advancement of officeshybased surgery however will depend not only on new technolshyogy but on development of safe effective and proven protocols for administration of adequate sedatives and analgesics in the OBS setting Residency and fellowship proshygrams are encouraged to provide the necessary and extensive training indispensible for managing the challenges of providshying appropriate analgesia and sedation in the office setting

Physicians must consult their state medical boards to meet any formal accreditation requirements Failure to comshyply with regulatory requirements may be grounds for license revocation It is worth noting that as of this writing only 9 states required accreditation once various thresholds have been crossed 25 states have no requirements for officeshybased surgery or office-based anesthesia [3435] In the absence of state regulations for OBS compliance with

both sta IS Impe the gui( particip Practic( most st OBS tf nizatior the pub surance standan

Refere

1 Lind in th

2 Porn in th 3(4 S

3 Se ti uial 2000

4 Bette esthe mell t

S Pract Anc Ane Ane

6 http menl

7 W Ori

a ne 1994

8 http1 htm

9 Pow menl

10 Wort

dorn~

Arne 1994

11 Lo~ guid line

12 Wort rt ec

13 Aldn 1970

14 Kun form LapG

IS Bem term hi po

63 2013 1I1T(1II101l el al Office-based Hysleroscopic Surgery

xIth state and federal Drug Enforcement Agency regulations 16 Emanuel MH Wamsteke r K The intrauterine morcellator a new hys shyteroscopic operating technique to remove intrauterine polyps and myoshy

Ii imperative In addition physicians are urged to adhere to mas J Minim Invasive Gynecol 2005 1262-66

savings to h~ guidelines set forth by the ACOG [32] and to consider 17 Papalampros P Gambadauro P Papadopoulos N et al The minishy

r icipation in the ACOG Safety Certification in Outpatientprefer the fashy resectoscope a new instrument for office hysteroscopic surgery Acta

the physishy IlJctice Excellence (SCOPE) for Women [36] Although Obslet Gynecol Scand 200988227-230

more efficient most states do not demand formal accreditation [35] for 18 Indman PD Office hysteroscopy In Cohen SM editor Operative Lapshyaroscopy and Hysteroscopy New York Churchill Livingstone 1996 wilh 08S the imprimatur of one of the major accreditation orgashyp239-250malions along with the ACOG SCOPE program provides

19 Connor VF Essure a review six years later J Minim II1(yive Gynecol thepublic and the professional staff with a measure of reasshy 200916282-290 urance and confidence that the facility has adhered to a high 20 Cicinelli E Hysteroscopy without anesthesia review of recent literashy

IJndard of clinical care ture J Minim In vasive Gynecology 2010 17703-708 21 Lau WC Lo WK Tam WH Yuen PM Paracervical anesthesia in outshy

References patient hysteroscopy a randomized double-blind placebo-controlledexperishy trial Br J Obstet Gynecol 1999 106356-359

ps in an OBS Lindheim SR Kavic S Shulman SV Sauer MY Operative hysteroscopy 22 Lopes P Giobon E Linet T Phillipe HJ Hysteroscopic tubal sterilizashy

nt electrodes in the office setti ng JAm Assoc Gynecol Laparosc 2000765- 69 tion with Essure intratubal devices a case-control prospective with inert Porreca MR Pansini N Bettocchi S et al Hysteroscopic polypectomy local anesthesia or without anesthesia Eur J Obstet Gynecol Reprod

in the office without anesthesia JAm Assoc Gynecol Laparosc 1996 Bioi 2008 138 199-203 )(4 Suppl)S40 23 Vercellini P Colombo A Mauro F et al Paracervical anesthesia for

Sesti F Marl iali N Santomarco N Hysteroscopic surgery for endomeshy outpatient hystcroscopy Fertil Sleril 199462 1083- 1085 tria l polyps using a bipolar microelectrode Int J Gynaecol Obstet 24 Munro MG Brooks PG Use of loca l anesthesia for office diagnostic ~OOO7 1283- 284 and operative hysteroscopy J Minim Invasi ve Gynecol 201017

- Bettocchi S Ceci 0 Nappi L et al Operative hysteroscopy without anshy 709- 718 elhesia analysis of 4863 cases performed with mechanical instrushy 25 Nagele F OConnor H Davies A et ai 2500 Outpatient diagnostic hysshyment JAm Assoc Gynecol 2004 II 59-61 teroscopies Obstet Gynecol 1996 8887-92

Prac tice Guidelines for Sedation and Analgesia by Nonshy 26 Mercorio F DeSimone R Landi P et al Oral dexketoprofen for pain Anesthesiologists an updated report by the American Society of treatment during diagnostic hysteroscopy in postmenopausal women nestheSiologists Task Force on Sedation and Analgesia by Nonshy Mawritas 2002 10277-28 1 nesthesiologist s Aneslhesiology 200296 1004-1017 27 Raffaele R Lanzone A Tagliaferri V et al Using a 16-French resecto shyRllplwwwnsahqorgFor-MemhersS tandards-Guidel ines-and-S tate scope as an alternative dev ice in the treatment of uterine lesions a ranshyl_ntsaspx Accessed August 12 20 I 2 domized controlled trial Obstet Gynecnl 2012 120 160-165 lIortman M Daggett A Hysteroscopic endomyometrial resection 28 Bettocchi S Nappi L Ccei 0 Selvaggi L What does diagnostic

the existence ~ nell technique for the treatment of menorrhagia Obstet Gynecol hysteroscopy mean today the role of the new techniques Curr

managed with 199482295-298 Opin Obslet Gynecol 2003 15303-308 bllpllwlVwhealthnygovprofessionalsoffice-based_surgerylaw230-d 29 Glasser MH Practical tips for office hysteroscopy and secondshyto provide him Acce~sed Jul y 5 2012 generation global endometrial ablation J Minim Invasive Gynecol perf rming adshy~Oiel SM Hill RK My copilot is a nurse using crew resource manageshy 2009 16384-399 ment in the OR AORN J 200683 179-180 30 Renner RM Jensen JT Nichol MD Edelman AB Pain control in firstshyWortman M Daggett Serum sodium changes during hysteroscopic enshy trimester surgical abortion a systematic rcvicw of randomized conshyilnt)ornetrial resection Paper presented at 23rd Annual Meeting of the trolled trial s Contraception 2010 8 1 372-388 merican Association of Gynecologic Laparoscopists October 18-24 31 Allen R Fortin J Bartz 0 et al Womens preferences for pain control 199 New York NY during first-trimester surgical abortion a qualitative study ContracepshyLoffer FD Bradley LP Brill AI et al Hysteroscopic fluid monitoring liol 20 1285413-418 roidd ines from the Ad Hoc Committee on Hysteroscopic Fluid Guideshy 32 Erickson TB Kirkpatrick DH DeFrancesco MS Executive Summary lines of the AAGL JAm Assoc Gynecol Laparosc 20007 I 67-168 of the American College of Obstetricians and Gynecologists Presidenshynman M Sonographically-guided hysteroscopic endomyometrial tial Task Force on Patient Safety in the Office Setting reinvigorating Ttlion Surg Tech IIlII 201221163-169 safety in office-based gynecologic surgery Obstet Gynecol 20 10

Aldrcte JA Kroulik D A post anesthetic recovery score Anesth Analg 115147-151 19i049924--933 33 Wortman M Daggett A Hysteroscopic endomyometrial resection

and proven unpound Re Vilos GA Thomas B et al A new bipolar system for pershy JSLS 20004 197-207 sedatives and lllmng operative hysteroscopy in normal saline JAm Assoc Gynecol 34 Wortman M Instituting an office-based surgery program in the gyneshy

fellowship proshy UJflllrosC 19993331 -336 cologists office J Minim In vllsive Gynecol 201017673-683 gelloccbi S Ceci 0 DiVenere R et al Advanced operative office hysshy 35 httpwww fsm b orgpd fIgrpo l_regulation_office_based_surgery pdf and extensive tregscopy without anesthesia analysis of 50 I cases treated with a 5 Fr Accessed August 12 20J 2lenges of providshy

rolar electrode Hum Reprod 2002 172435-2438 36 httpwwwscopeforwomenshealthorg Accessed August 152012 office setting ical boards to

ments for officeshya [3435] In the compliance with

Page 7: lVorrml1 OF...Patients: Women undergoing operative hysteroscopy in an office setting, Interventions: Three hundred eighty-seven women underwent a total of 414 operative hysteroscopic

l

(

62 Journal ofMinimally Invasive Gynecology Vol 20 No 1 JanuoryFebruary 2013 W Oflll1GIl

a muscular layer lt I cm in thickness as distention occurs Pashytients who experience uterine rupture do not seem to note increased pain during or immediately after the procedure

The present study does not include long-term outcomes however it is worth noting that in women who underwent endomyometrial resection without myomectomy the avershyage specimen weight of 119 g compares favorably with our (MW and AD) previous series that was performed with the patients under general anesthesia [33]

The limitations of the present study include its retrospecshytive nature and that telephone surveys are prone to some elshyement of selection bias inasmuch as dissatisfied patients are less likely to respond Surveys performed at varying intershyvals after the original procedure are likely to be less accurate than surveys conducted within a standardized interval such as 24 to 72 hours after completion Another limiting factor of the present study is that women who experience favorable menstrual outcomes are more apt to report greater rates of satisfaction with office-based surgery Additional studies will be necessary to determine whether the rates of repeat operation in women undergoing office-based hysteroscopic surgery are comparable with those that we have reported in a hospital or ambulatory surgical center setting [33]

Gynecologists considering incorporation of operative hysteroscopy into an OBS setting must carefully consider the costs of initiating such a program Expenses will vary with local regulatory and state medical board requirements equipment that is already available to the practitioner and whether used or new instruments are purchased Many offices may already own much of the necessary paraphernashylia such as an office-appropriate operating room table an electrosurgical generator a video camera with monitor an ultrasound machine and an emergency cart Fluid manageshyment systems and resectoscopes can often be purchased from companies specializing in used medical equipment at a fraction of the cost of their newer models The importance of redundant equipment in particular a second resectoscope cannot be overstated In the final analysis one must consider the expected patient volume and start-up costs before investshying substantial time and resources

Finally one must consider that the benefits to the physishycian are maximized when OBS blends well into the daily pashytient flow of ones practice We find it most useful to schedule operative hysteroscopic procedures as the first case in either the morning or afternoon session Although we have accommodated as many as 6 operative hysteroshyscopic procedures in a week we believe that 1 or 2 proceshydures per week is sufficient for the physician to derive the benefits of OBS while enabling the operating room crew to develop and maintain the necessary skills required for pashytient safety

Conclusions

The advantages of office-based hysteroscopic surgery are 4-fold First it often enables the gynecologist to combine the

diagnostic and treatment phases of patient management obshyviating the need for multiple interventions and anesthetics Second this approach produces substantial cost savings to the insurer and the patient Third many women prefer the fashymiliar environment of the office setting Fourth the physishycian benefits from the ease of scheduling more efficient use of time and improved reimbursement compared with hospital- or ambulatory surgical center-based procedures

There are 2 advantages of a large-diameter resectoscope its efficiency and adaptability to a variety of concomitant procedures It is particularly efficient in removing large quantities of tissue that is not possible with smaller instrushyments Bettocchi et al [15] who have considerable experishyence in removal of leiomyomas and polyps in an OBS setting note that the use of the SF Versapoint electrodes to treat these larger myomas (greater than 2 cm) is time conshysuming and yields lower quality final results In addition the larger-diameter resectoscope is adaptable to all types of hysteroscopic procedures including endomyometrial reshysection polypectomy myomectomy and repeat operative hysteroscopy in many cases 2 of more of these procedures are required in the same patient The use of a single instrushyment obviates the need for multiple specialized instruments such as a nonresectoscopic endometrial ablation device combined with a resectoscope or tissue morcellation apparashytus for management of menorrhagia in a woman with a modshyerately sized submucous leiomyoma

The limitations on hysteroscopic surgery in an OBS setshyting are 3-fold operator skill and experience the existence of intrauterine disease beyond what can be managed with a small-diameter hysteroscope and the capacity to provide patient comfort Patient comfort is critical in performing adshyvanced office-based procedures

We have demonstrated that a large-diameter resectoscope can be safely used in a properly equipped and accredited ofshyfice by a physician working with a dedicated and motivated operating room team However patient satisfaction requires careful consideration of her need for analgesia and sedation

The influx of numerous technologic innovations in the past 2 decades has increased the range of what is possible in an office setting The continued advancement of officeshybased surgery however will depend not only on new technolshyogy but on development of safe effective and proven protocols for administration of adequate sedatives and analgesics in the OBS setting Residency and fellowship proshygrams are encouraged to provide the necessary and extensive training indispensible for managing the challenges of providshying appropriate analgesia and sedation in the office setting

Physicians must consult their state medical boards to meet any formal accreditation requirements Failure to comshyply with regulatory requirements may be grounds for license revocation It is worth noting that as of this writing only 9 states required accreditation once various thresholds have been crossed 25 states have no requirements for officeshybased surgery or office-based anesthesia [3435] In the absence of state regulations for OBS compliance with

both sta IS Impe the gui( particip Practic( most st OBS tf nizatior the pub surance standan

Refere

1 Lind in th

2 Porn in th 3(4 S

3 Se ti uial 2000

4 Bette esthe mell t

S Pract Anc Ane Ane

6 http menl

7 W Ori

a ne 1994

8 http1 htm

9 Pow menl

10 Wort

dorn~

Arne 1994

11 Lo~ guid line

12 Wort rt ec

13 Aldn 1970

14 Kun form LapG

IS Bem term hi po

63 2013 1I1T(1II101l el al Office-based Hysleroscopic Surgery

xIth state and federal Drug Enforcement Agency regulations 16 Emanuel MH Wamsteke r K The intrauterine morcellator a new hys shyteroscopic operating technique to remove intrauterine polyps and myoshy

Ii imperative In addition physicians are urged to adhere to mas J Minim Invasive Gynecol 2005 1262-66

savings to h~ guidelines set forth by the ACOG [32] and to consider 17 Papalampros P Gambadauro P Papadopoulos N et al The minishy

r icipation in the ACOG Safety Certification in Outpatientprefer the fashy resectoscope a new instrument for office hysteroscopic surgery Acta

the physishy IlJctice Excellence (SCOPE) for Women [36] Although Obslet Gynecol Scand 200988227-230

more efficient most states do not demand formal accreditation [35] for 18 Indman PD Office hysteroscopy In Cohen SM editor Operative Lapshyaroscopy and Hysteroscopy New York Churchill Livingstone 1996 wilh 08S the imprimatur of one of the major accreditation orgashyp239-250malions along with the ACOG SCOPE program provides

19 Connor VF Essure a review six years later J Minim II1(yive Gynecol thepublic and the professional staff with a measure of reasshy 200916282-290 urance and confidence that the facility has adhered to a high 20 Cicinelli E Hysteroscopy without anesthesia review of recent literashy

IJndard of clinical care ture J Minim In vasive Gynecology 2010 17703-708 21 Lau WC Lo WK Tam WH Yuen PM Paracervical anesthesia in outshy

References patient hysteroscopy a randomized double-blind placebo-controlledexperishy trial Br J Obstet Gynecol 1999 106356-359

ps in an OBS Lindheim SR Kavic S Shulman SV Sauer MY Operative hysteroscopy 22 Lopes P Giobon E Linet T Phillipe HJ Hysteroscopic tubal sterilizashy

nt electrodes in the office setti ng JAm Assoc Gynecol Laparosc 2000765- 69 tion with Essure intratubal devices a case-control prospective with inert Porreca MR Pansini N Bettocchi S et al Hysteroscopic polypectomy local anesthesia or without anesthesia Eur J Obstet Gynecol Reprod

in the office without anesthesia JAm Assoc Gynecol Laparosc 1996 Bioi 2008 138 199-203 )(4 Suppl)S40 23 Vercellini P Colombo A Mauro F et al Paracervical anesthesia for

Sesti F Marl iali N Santomarco N Hysteroscopic surgery for endomeshy outpatient hystcroscopy Fertil Sleril 199462 1083- 1085 tria l polyps using a bipolar microelectrode Int J Gynaecol Obstet 24 Munro MG Brooks PG Use of loca l anesthesia for office diagnostic ~OOO7 1283- 284 and operative hysteroscopy J Minim Invasi ve Gynecol 201017

- Bettocchi S Ceci 0 Nappi L et al Operative hysteroscopy without anshy 709- 718 elhesia analysis of 4863 cases performed with mechanical instrushy 25 Nagele F OConnor H Davies A et ai 2500 Outpatient diagnostic hysshyment JAm Assoc Gynecol 2004 II 59-61 teroscopies Obstet Gynecol 1996 8887-92

Prac tice Guidelines for Sedation and Analgesia by Nonshy 26 Mercorio F DeSimone R Landi P et al Oral dexketoprofen for pain Anesthesiologists an updated report by the American Society of treatment during diagnostic hysteroscopy in postmenopausal women nestheSiologists Task Force on Sedation and Analgesia by Nonshy Mawritas 2002 10277-28 1 nesthesiologist s Aneslhesiology 200296 1004-1017 27 Raffaele R Lanzone A Tagliaferri V et al Using a 16-French resecto shyRllplwwwnsahqorgFor-MemhersS tandards-Guidel ines-and-S tate scope as an alternative dev ice in the treatment of uterine lesions a ranshyl_ntsaspx Accessed August 12 20 I 2 domized controlled trial Obstet Gynecnl 2012 120 160-165 lIortman M Daggett A Hysteroscopic endomyometrial resection 28 Bettocchi S Nappi L Ccei 0 Selvaggi L What does diagnostic

the existence ~ nell technique for the treatment of menorrhagia Obstet Gynecol hysteroscopy mean today the role of the new techniques Curr

managed with 199482295-298 Opin Obslet Gynecol 2003 15303-308 bllpllwlVwhealthnygovprofessionalsoffice-based_surgerylaw230-d 29 Glasser MH Practical tips for office hysteroscopy and secondshyto provide him Acce~sed Jul y 5 2012 generation global endometrial ablation J Minim Invasive Gynecol perf rming adshy~Oiel SM Hill RK My copilot is a nurse using crew resource manageshy 2009 16384-399 ment in the OR AORN J 200683 179-180 30 Renner RM Jensen JT Nichol MD Edelman AB Pain control in firstshyWortman M Daggett Serum sodium changes during hysteroscopic enshy trimester surgical abortion a systematic rcvicw of randomized conshyilnt)ornetrial resection Paper presented at 23rd Annual Meeting of the trolled trial s Contraception 2010 8 1 372-388 merican Association of Gynecologic Laparoscopists October 18-24 31 Allen R Fortin J Bartz 0 et al Womens preferences for pain control 199 New York NY during first-trimester surgical abortion a qualitative study ContracepshyLoffer FD Bradley LP Brill AI et al Hysteroscopic fluid monitoring liol 20 1285413-418 roidd ines from the Ad Hoc Committee on Hysteroscopic Fluid Guideshy 32 Erickson TB Kirkpatrick DH DeFrancesco MS Executive Summary lines of the AAGL JAm Assoc Gynecol Laparosc 20007 I 67-168 of the American College of Obstetricians and Gynecologists Presidenshynman M Sonographically-guided hysteroscopic endomyometrial tial Task Force on Patient Safety in the Office Setting reinvigorating Ttlion Surg Tech IIlII 201221163-169 safety in office-based gynecologic surgery Obstet Gynecol 20 10

Aldrcte JA Kroulik D A post anesthetic recovery score Anesth Analg 115147-151 19i049924--933 33 Wortman M Daggett A Hysteroscopic endomyometrial resection

and proven unpound Re Vilos GA Thomas B et al A new bipolar system for pershy JSLS 20004 197-207 sedatives and lllmng operative hysteroscopy in normal saline JAm Assoc Gynecol 34 Wortman M Instituting an office-based surgery program in the gyneshy

fellowship proshy UJflllrosC 19993331 -336 cologists office J Minim In vllsive Gynecol 201017673-683 gelloccbi S Ceci 0 DiVenere R et al Advanced operative office hysshy 35 httpwww fsm b orgpd fIgrpo l_regulation_office_based_surgery pdf and extensive tregscopy without anesthesia analysis of 50 I cases treated with a 5 Fr Accessed August 12 20J 2lenges of providshy

rolar electrode Hum Reprod 2002 172435-2438 36 httpwwwscopeforwomenshealthorg Accessed August 152012 office setting ical boards to

ments for officeshya [3435] In the compliance with

Page 8: lVorrml1 OF...Patients: Women undergoing operative hysteroscopy in an office setting, Interventions: Three hundred eighty-seven women underwent a total of 414 operative hysteroscopic

63 2013 1I1T(1II101l el al Office-based Hysleroscopic Surgery

xIth state and federal Drug Enforcement Agency regulations 16 Emanuel MH Wamsteke r K The intrauterine morcellator a new hys shyteroscopic operating technique to remove intrauterine polyps and myoshy

Ii imperative In addition physicians are urged to adhere to mas J Minim Invasive Gynecol 2005 1262-66

savings to h~ guidelines set forth by the ACOG [32] and to consider 17 Papalampros P Gambadauro P Papadopoulos N et al The minishy

r icipation in the ACOG Safety Certification in Outpatientprefer the fashy resectoscope a new instrument for office hysteroscopic surgery Acta

the physishy IlJctice Excellence (SCOPE) for Women [36] Although Obslet Gynecol Scand 200988227-230

more efficient most states do not demand formal accreditation [35] for 18 Indman PD Office hysteroscopy In Cohen SM editor Operative Lapshyaroscopy and Hysteroscopy New York Churchill Livingstone 1996 wilh 08S the imprimatur of one of the major accreditation orgashyp239-250malions along with the ACOG SCOPE program provides

19 Connor VF Essure a review six years later J Minim II1(yive Gynecol thepublic and the professional staff with a measure of reasshy 200916282-290 urance and confidence that the facility has adhered to a high 20 Cicinelli E Hysteroscopy without anesthesia review of recent literashy

IJndard of clinical care ture J Minim In vasive Gynecology 2010 17703-708 21 Lau WC Lo WK Tam WH Yuen PM Paracervical anesthesia in outshy

References patient hysteroscopy a randomized double-blind placebo-controlledexperishy trial Br J Obstet Gynecol 1999 106356-359

ps in an OBS Lindheim SR Kavic S Shulman SV Sauer MY Operative hysteroscopy 22 Lopes P Giobon E Linet T Phillipe HJ Hysteroscopic tubal sterilizashy

nt electrodes in the office setti ng JAm Assoc Gynecol Laparosc 2000765- 69 tion with Essure intratubal devices a case-control prospective with inert Porreca MR Pansini N Bettocchi S et al Hysteroscopic polypectomy local anesthesia or without anesthesia Eur J Obstet Gynecol Reprod

in the office without anesthesia JAm Assoc Gynecol Laparosc 1996 Bioi 2008 138 199-203 )(4 Suppl)S40 23 Vercellini P Colombo A Mauro F et al Paracervical anesthesia for

Sesti F Marl iali N Santomarco N Hysteroscopic surgery for endomeshy outpatient hystcroscopy Fertil Sleril 199462 1083- 1085 tria l polyps using a bipolar microelectrode Int J Gynaecol Obstet 24 Munro MG Brooks PG Use of loca l anesthesia for office diagnostic ~OOO7 1283- 284 and operative hysteroscopy J Minim Invasi ve Gynecol 201017

- Bettocchi S Ceci 0 Nappi L et al Operative hysteroscopy without anshy 709- 718 elhesia analysis of 4863 cases performed with mechanical instrushy 25 Nagele F OConnor H Davies A et ai 2500 Outpatient diagnostic hysshyment JAm Assoc Gynecol 2004 II 59-61 teroscopies Obstet Gynecol 1996 8887-92

Prac tice Guidelines for Sedation and Analgesia by Nonshy 26 Mercorio F DeSimone R Landi P et al Oral dexketoprofen for pain Anesthesiologists an updated report by the American Society of treatment during diagnostic hysteroscopy in postmenopausal women nestheSiologists Task Force on Sedation and Analgesia by Nonshy Mawritas 2002 10277-28 1 nesthesiologist s Aneslhesiology 200296 1004-1017 27 Raffaele R Lanzone A Tagliaferri V et al Using a 16-French resecto shyRllplwwwnsahqorgFor-MemhersS tandards-Guidel ines-and-S tate scope as an alternative dev ice in the treatment of uterine lesions a ranshyl_ntsaspx Accessed August 12 20 I 2 domized controlled trial Obstet Gynecnl 2012 120 160-165 lIortman M Daggett A Hysteroscopic endomyometrial resection 28 Bettocchi S Nappi L Ccei 0 Selvaggi L What does diagnostic

the existence ~ nell technique for the treatment of menorrhagia Obstet Gynecol hysteroscopy mean today the role of the new techniques Curr

managed with 199482295-298 Opin Obslet Gynecol 2003 15303-308 bllpllwlVwhealthnygovprofessionalsoffice-based_surgerylaw230-d 29 Glasser MH Practical tips for office hysteroscopy and secondshyto provide him Acce~sed Jul y 5 2012 generation global endometrial ablation J Minim Invasive Gynecol perf rming adshy~Oiel SM Hill RK My copilot is a nurse using crew resource manageshy 2009 16384-399 ment in the OR AORN J 200683 179-180 30 Renner RM Jensen JT Nichol MD Edelman AB Pain control in firstshyWortman M Daggett Serum sodium changes during hysteroscopic enshy trimester surgical abortion a systematic rcvicw of randomized conshyilnt)ornetrial resection Paper presented at 23rd Annual Meeting of the trolled trial s Contraception 2010 8 1 372-388 merican Association of Gynecologic Laparoscopists October 18-24 31 Allen R Fortin J Bartz 0 et al Womens preferences for pain control 199 New York NY during first-trimester surgical abortion a qualitative study ContracepshyLoffer FD Bradley LP Brill AI et al Hysteroscopic fluid monitoring liol 20 1285413-418 roidd ines from the Ad Hoc Committee on Hysteroscopic Fluid Guideshy 32 Erickson TB Kirkpatrick DH DeFrancesco MS Executive Summary lines of the AAGL JAm Assoc Gynecol Laparosc 20007 I 67-168 of the American College of Obstetricians and Gynecologists Presidenshynman M Sonographically-guided hysteroscopic endomyometrial tial Task Force on Patient Safety in the Office Setting reinvigorating Ttlion Surg Tech IIlII 201221163-169 safety in office-based gynecologic surgery Obstet Gynecol 20 10

Aldrcte JA Kroulik D A post anesthetic recovery score Anesth Analg 115147-151 19i049924--933 33 Wortman M Daggett A Hysteroscopic endomyometrial resection

and proven unpound Re Vilos GA Thomas B et al A new bipolar system for pershy JSLS 20004 197-207 sedatives and lllmng operative hysteroscopy in normal saline JAm Assoc Gynecol 34 Wortman M Instituting an office-based surgery program in the gyneshy

fellowship proshy UJflllrosC 19993331 -336 cologists office J Minim In vllsive Gynecol 201017673-683 gelloccbi S Ceci 0 DiVenere R et al Advanced operative office hysshy 35 httpwww fsm b orgpd fIgrpo l_regulation_office_based_surgery pdf and extensive tregscopy without anesthesia analysis of 50 I cases treated with a 5 Fr Accessed August 12 20J 2lenges of providshy

rolar electrode Hum Reprod 2002 172435-2438 36 httpwwwscopeforwomenshealthorg Accessed August 152012 office setting ical boards to

ments for officeshya [3435] In the compliance with


Recommended