CLINICAL OUTCOMES IN GYN SURGERY Summary Slide Deck_… · CLINICAL OUTCOMES IN GYN SURGERY ......

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CLINICAL OUTCOMES IN GYN SURGERY WITH THE DA VINCI® SURGICAL SYSTEM

SACROCOLPOPEXY

MYOMECTOMY ENDOMETRIOSIS RESECTION OTHER

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SELECT PROCEDURE TO BEGIN >

HYSTERECTOMY – CANCER HYSTERECTOMY – BENIGN

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DA VINCI® HYSTERECTOMY – CANCER HC

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INDEX – Hysterectomy Cancer STUDY MAIN

AUTHOR(S) YEAR

Comparative Safety And Effectiveness Of Robot-assisted Laparoscopic Hysterectomy Versus Conventional Laparoscopy And Laparotomy For Endometrial Cancer: A Systematic Review And Meta-analysis

Park, Kim 2016

Incorporating Robotic-assisted Surgery For Endometrial Cancer Staging: Analysis Of Morbidity And Costs

Bogani 2016

Robotically Assisted Para-aortic Lymphadenectomy: Surgical Results Hudry 2015

Cost-effectiveness Of Conventional Vs Robotic-assisted Laparoscopy In Gynecologic Oncologic Indications

Marino 2015

Robot-assisted Radical Hysterectomy In Cervical Carcinoma Segaert 2015

Cost-effectiveness Analysis Of Robotically Assisted Laparoscopy For Newly Diagnosed Uterine Cancers

Leitao 2014

Laparoscopy Vs Robotics In Surgical Management Of Endometrial Cancer: Comparison Of Intraoperative And Postoperative Complications

Seror, Lecuru 2014

Introducing Robotics Reduces The Number Of Laparotomies And Saves Money In A Tertiary Referral Endometrial Cancer Service (SERGS)

Ind 2014

Outcomes And Cost Comparisons After Introducing A Robotics Program For Endometrial Cancer Surgery

Lau 2012

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INDEX – Hysterectomy Cancer (Cont.) STUDY MAIN

AUTHOR(S) YEAR

Introduction Of A Computer-based Surgical Platform In The Surgical Case Of Patients With Newly Diagnosed Uterine Cancer: Outcomes And Impact On Approach

Leitao 2012

Surgical Outcomes In Gynecologic Oncology In The Era Robotics: Analysis Of First 1000 Cases

Paley 2011

Robot-assisted Radical Hysterectomy- Perioperative And Survival Outcomes In Patients For Cervical Cancer Compared To Laparoscopic And Open Radical Surgery

Gortchev 2011

Learning Curve And Surgical Outcome For Robotic Assisted Hysterectomy With Lymphadenectomy: Case-matched Controlled Comparison With Laparoscopy And Laparotomy For Treatment Of Endometrial Cancer

Lim 2010

Comprehensive Surgical Staging For Endometrial Cancer In Obese Patients Seamon 2009

A comparative study of 3 surgical methods for hysterectomy with staging for endometrial cancer: robotic assistance, laparoscopy, laparotomy

Boggess 2008

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Comparative safety and effectiveness of robot-assisted laparoscopic hysterectomy versus conventional laparoscopy and laparotomy for endometrial cancer

D.A. Park, D.H. Lee, S.W. Kim, S.H. Lee, Comparative safety and effectiveness of robot-assisted laparoscopic hysterectomy versus conventional laparoscopy and laparotomy for endometrial cancer: A systematic review and meta-analysis, EJSO (2016), doi: 10.1016/j.ejso.2016.06.400

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Overview • This publication evaluates the surgical safety and clinical effectiveness of robot-assisted

hysterectomy (RH) compared to open hysterectomy (OH) and to laparoscopic hysterectomy (LH) for endometrial cancer.

• This publication reports the results of a systematic review of 37 studies, which included the largest number of cases compared to those reported in previous studies. − 24 studies compared RH to OH, 24 studies compared RH to LH, and

9 studies compared all 3 groups.

• The studies included in this publication feature the most recent comparative surgical results as of September 2016. Databases used were Ovid-Medline, Ovid-EMBASE, and Cochrane Library through May 2015; along with 5 Korean databases (KoreaMed, Kmbase, KISS, RISS, and KisTi) without restriction of publication year or language.

• The selection of articles, data analysis and results reporting are based on Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines.



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RH versus OH RH versus LH

No. of Studies 24 Year of Publication

2008-2015

Countries Represented

USA (14), Canada (2), Sweden (2), India (1), Korea (1), Singapore(1),

Spain(1), Taiwan (1), Turkey (1)

Study Design Nonconcurrent (14), Retrospective(8), Prospective (1), NRCT (1)

Setting Single Center (23), Multi-Center (1) Total No. of Patients 3,511

Characteristic RH OH Age Range (Years) 51-78 50-77

Mean BMI Range (kg/m2) 23-51 25-54

Characteristic RH LH Age Range (Years) 54-67 51-69 Mean BMI Range (kg/m2) 23-51 25-48

No. of Studies 24 Year of Publication

2008-2015

Countries Represented

USA (18), France(2), Finland (1), Korea (1), Spain(1), Taiwan (1)

Study Design Nonconcurrent (12), Retrospective(10),

Prospective (2)

Setting Single Center (23), Multi-Center (1)

Total No. of Patients

3,755*

*Reported as 3,511 in the study


Characteristics of Included Studies

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Outcomes OH RR/WMD * LH RR/WMD Overall complications + RR 0.37 RR 0.76 Intra-operative complications + RR 0.43 + RR 0.23 Post-operative complications + RR 0.48 RR 0.76 Readmission + RR 0.48 Not reported Not reported Vaginal cuff dehiscence – RR 3.11 Not reported Not reported Transfusion + RR 0.28 RR 0.66 Estimated blood loss + WMD -171.22 + WMD -93.09 Length of stay + WMD -2.87 + WMD -0.51 Conversion to laparotomy NA NA + RR 0.36 Operating time – WMD 30.43 WMD 11.56 Total lymph nodes count WMD 1.51 WMD 0.21 Death within 30 days RR 0.60 ** Not reported

* RR: Risk ratio | WMD: Weighted mean difference | NA: Not applicable ** Only one study reported no death

Results of RH in Comparison to OH and LH

+ Favorable for RH – Unfavorable for RH Comparable


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Conclusion • RH may be a generally safer and better option than OH and LH for patients with

endometrial cancer. • RH may have advantages in reducing overall complications, length of stay (LOS),

estimated blood loss (EBL), transfusion, and readmissions compared to OH and in reducing LOS, EBL, and intraoperative complications compared to those of LH in surgery for endometrial cancer.

Limitations • Reviewed studies were non-randomized and non-concurrent, with a high risk of

selection bias. • Most studies were researched in a single center and in the U.S.


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Overview • Evaluation of how the introduction of robotic-assisted surgery affects treatment-related morbidity and

cost of endometrial cancer (EC) staging. • Retrospective review of consecutive patients with stage I-III endometrial cancer who underwent

surgical staging between 2007 and 2012 at the Mayo Clinic (Rochester, MN). • Analysis looked at the 251 endometrial cancer patients who had robotic-assisted surgery and the 384

who had open staging. • Costs (from surgery to 30 days after surgery) were set based on the Medicare cost-to-charge ratio for

each year, inflated to 2014 values. Timeframe was expanded to include the 30-day readmission period due to hospitals’ increased focus on readmission rates and associated costs.

• Inverse probability weighting (IPW) was used to decrease the allocation bias when comparing outcomes between surgical groups.

Incorporating Robotic-Assisted Surgery for Endometrial Cancer Staging: Analysis of Morbidity and Costs

Giorgio Bogani, Francesco Multinu, Sean C. Dowdy, William A. Cliby, Timothy O. Wilson, Bobbie S. Gostout, Amy L. Weaver, Bijan J. Borah, Jill M. Killian, Akash Bijlani, Stefano Angioni, Andrea Mariani, Incorporating robotic-assisted surgery for endometrial cancer staging: Analysis of morbidity and costs, Gynecologic Oncology (2016), doi: 10.1016/j.ygyno.2016.02.016

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† Values are weighted percentage or weighted median (weighted interquartile range); a Postoperative complications were within 30 days of the surgery and were graded per the Accordion classification as part of the data collection;b Room and board costs included costs of regular room and any intensive care unit stay; c Only patients with costs after hospital discharge


IPW COHORT† Open (n = 383.1) Robotic-Assisted (n = 247.8) P-Value

Intraoperative Complication 1.2% 0.4% 0.27 Postoperative Complication Grade ≥2a 29.3% 8.1% <.001 Postoperative Complication Grade ≥3a 9.6% 3.0% 0.002 Blood Transfusion 21.6% 4.8% <.001 Operating Time (hours) 2.8 (2.2–3.5) 4.5 (3.8–5.5) <.001 Length of Stay (days) 4 (3-5) 1 (1-2) <.001 Readmission within 30 days 12.8% 3.2% <.001 Overall, surgery to 30 days post surgery $19,895 ($16,860–$25,303) $19,504 ($17,346–$23,619) 0.49 Initial hospitalization, surgery to discharge $19,295 ($16,239–$22,690) $19,147 ($17,191–$22,841) 0.76 Anesthesia $700 ($604–$785) $893 ($782–$997) <.001 Operating Room Costs $4,444 ($4,052-$4,937) $7,264 ($6,666-$8,459) <.001 Room & Board Costsb $4,180 ($3,393-$5,789) $1,251 ($1,131-$2,411) <.001 Discharge to 30 days post surgeryc $1580 ($191–$6905) (n = 152) $626 ($214–$1972) (n = 102) 0.10

Inverse Probability Weighted (IPW) patients were matched 1:1 between robotic and open approaches on several factors: 1) the logit of the propensity score within 0.2 of the SD, 2) surgery date within 180 days in the same calendar year, and 3) tumor histology. For each robotic case, a patient with open staging was randomly selected from the patient pool based on the matching criteria.


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Results • The implementation of robotic-assisted technology decreased the rate of open abdominal staging for endometrial

cancer (P<.001). • Patients undergoing robotic-assisted staging had a significantly lower postoperative complication rate, lower blood

transfusion rate, longer median operating time, shorter median length of stay and lower readmission rate than patients undergoing open staging (all P<.001).

• Overall 30-day costs were similar between the two groups, with robotic-assisted surgery having significantly higher median operating room costs ($2,820 difference; P<.001) but lower median room and board costs than open surgery ($2,929 difference; P<.001).

• When PS & IPW methods were used to account for the differences between the cohorts, perioperative clinical outcomes were still significantly better in the robotic-assisted population, but with similar total costs.

• Conversion from robotic-assisted to open surgery increases morbidity and costs. • Increased experience with robotic-assisted staging was associated with a decrease in median operating time

(P=.002) and length of stay (P=.003).

Conclusion • The implementation of robotic-assisted surgery for endometrial cancer staging improved patient outcomes. It

provides women the benefit of minimally invasive surgery without increasing costs and potentially improves patient turnover.

Limitations • Single-institution, retrospective, nonrandomized study design. • Amortization cost not included.



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Overview • Retrospective multicentric study: 11 European centers and 1 US center participated in this study, which

was done in collaboration with the Society of European Robotic Gynecological Surgery (SERGS). • The study analyzed clinical outcomes data on 487 patients who underwent robotically assisted PAL

between November 2004 and March 2012. • PAL was performed as either an isolated procedure, or as a procedure combined with a hysterectomy,

pelvic lymphadenectomy, or omentectomy. – Extraperitoneal approach in 58 cases (12%) and transperitoneal in 429 cases (88%).

• The primary aim: To evaluate the safety and feasibility of robotic-assisted laparoscopic PAL and to compare these results with reported peer-reviewed literature.

• The secondary aim: To compare extraperitoneal and transperitoneal approaches, and the results of isolated PAL versus PAL combined with another gynecological surgical procedure.

Robotically Assisted Para-aortic Lymphadenectomy: Surgical Results

Hudry D, Ahmad S, Zanagnolo V, et al. Robotically assisted para-aortic lymphadenectomy: surgical results. Int J Gynecol Cancer. 2015;25:504-511.

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Robotically Assisted Para-aortic Lymphadenectomy: Surgical Results

OT, min EBL, ml LOS, d Lymph Nodes Retrieved

Total population (N=487) 217.6 (85.1) 105.4 (109.9) 2.8 (3.2) 12.6 (8.1)

Transperitoneal PAL (n = 429)

Combined procedures (n = 357)

225.6 (89.2) 100.2 (104.1) 2.6 (3.3) 10.9 (6.9)

Isolated procedures (n = 72)

200.4 (66) 149.8 (118.8) 3.5 (1.9) 16.6 (8.9)

p value 0.007 0.053 0.0007 1.5 X 10-06

Isolated PAL (n = 121)

Transperitoneal access (n = 72)

200.4 (66) 149.8 (118.8) 3.5 (1.9) 16.6 (8.9)

Extraperitoneal access (n = 49)

177.1 (62.7) 113.5 (132.8) 2.7 (0.8) 18.3 (9.4)

p value 0.054 0.28 0.001 0.32

Data are presented as mean (SD). d, days; EBL, estimated blood loss; OT, operative time; LOS, hospital length of stay; PAL, para-aortic lymphadenectomy

Table 1: Surgical outcomes of 487 patients who underwent robotic-assisted laparoscopic PAL


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Robotically-Assisted Para-aortic Lymphadenectomy: Surgical Results

Conversions or Complications Results for Total Population (N=487) Conversion to open 4 (0.8%)

Conversion to laparoscopy 2 (0.4%)

Intraoperative complications 21 (4.3%)

Postoperative complications 108 (22.2%)

Grade I Data not collected

Grade II 66 (13.6%)

DVT 3 (0.6%)

Grade III 42 (8.6%)

Lymphocyst 32 (6.6%)

Grade IIIA 35 (7.2%)

Grade IIIB 7 (1.4%)

Table 2: Conversions and complications for 487 patients who underwent robotic-assisted laparoscopic PAL


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Results • The mean and median numbers of lymph nodes retrieved are comparable to published results for

conventional laparoscopic PAL. The OT, EBL, and LOS are also equivalent with published results.

• The number of retrieved lymph nodes was higher in isolated PAL than in combined procedures regardless of the patients’ age, BMI, and indication.

• The hospital LOS was longer in the isolated PAL cases.

• Transperitoneal isolated PAL had a longer hospital LOS than extraperitoneal isolated PAL, regardless of the patients’ age and/or BMI.

• The postoperative complication rate (22.2%) and intraoperative rate(4.4%) are comparable to other published gynecological robotic-surgery studies.

• Few intraoperative complications required conversion to laparotomy (0.8%), and grade IIIB postoperative complications (1.4%) requiring a second operative intervention were infrequent.

• Lymphatic complications were the most frequent with 32 patients affected (6.6%). This lymphocyst rate is comparable to other laparoscopic approaches.



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Conclusion • This multicenter study demonstrates the feasibility and the overall safety of robotic-assisted PAL, even in

the early learning curve of robotic surgery programs. • Robotic-assisted PAL seems to have a relatively low incidence of perioperative morbidity. • Hospital LOS was shorter for extraperitoneal isolated PAL cases. The superiority of an extraperitoneal or

transperitoneal approach remains to be demonstrated. • Most combined PAL procedures used a single pelvic docking that allows reaching the inferior

mesenteric artery but not the left renal vein. This suggests that using dual docking for combined PAL procedures would improve the number of lymph nodes retrieved.

Limitations • The study design introduced selection bias, and results may not be representative of all patients who

have undergone robotically assisted PAL. • The anatomical landmarks used in robotic PAL varied. In addition, data collected includes the first

learning-curve procedures of each team. These variables could affect the number of lymph nodes retrieved per case.

• Hospital LOS results could likely be explained by the proportion of patients managed in the U.S. in this cohort (45.8%); typically hospital LOS in the U.S. is significantly shorter than in Europe.



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Overview • The aim of this study was to compare the costs and clinical outcomes of conventional laparoscopy with

robotic-assisted laparoscopy in gynecologic oncologic indications.

− Costs were based on the use of a da Vinci S® Surgical System.

• Between 2007 and 2010, in 16 centers, 306 patients referred for gynecologic oncologic indications (endometrial and cervical cancer) were included prospectively and followed up for 2 years.

− 226 conventional laparoscopy cases

− 80 robotic-assisted laparoscopy cases (4 centers)

• Most of the patients’ demographic and clinical characteristics were similar in both surgical groups.

Cost-Effectiveness of Conventional vs Robotic-Assisted Laparoscopy in Gynecologic Oncologic Indications

Marino P, Houvenaeghel G, Narducci F, Boyer-Chammard A, Ferron G, Uzan C, Bats AS, Mathevet P, Dessogne P, Guyon F, Rouanet P, Jaffre I, Carcopino X, Perez T, Lambaudie E. Cost-Effectiveness of Conventional vs Robotic-Assisted Laparoscopy in Gynecologic Oncologic Indications. Int J Gynecol Cancer. 2015 Jul;25(6):1102-8.

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*Costs include French value-added tax (VAT). VAT rates differ among countries, and depend on tax status and eligibility for VAT recovery. **Based on 165 procedures/year and a 7-year depreciation rate; ***Based on 165 procedures/year; Data are presented as mean (SD); NA = not applicable

Cost Factor Robotic-Assisted Surgery (N=80), Euro

Laparoscopic Surgery (N=226), Euro p-value

PURCHASE PRICE OF ROBOT Cost per procedure** 1346 (NA 0 (NA) NA

MAINTENANCE Cost per procedure*** 867 (NA) 0 (NA) NA

Surgical supplies 957 (566) 1432 (575) 0.001 Hospital costs 2380 (1880) 2841 (6020) <0.001

Conventional unit 1623 (1286) 1609 (1335) Intensive care unit 476 (1234) 1142 (5351)

Operating theater costs 1490 (341) 1311 (392) 0.004 Total Cost 7040 (1376) 5584 (1470) <0.001 EXTRA COST/PATIENT OF USING THE ROBOT Based on 165 procedures/year 1456 NA NA Based on 200 procedures/year 1069 NA NA Based on 250 procedures/year 703 NA NA Based on 300 procedures/year 460 NA NA

Cost estimates of robotic-assisted surgery vs. laparoscopic surgery*


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Results • Based on an average number of 165 surgical cases performed per year with the robot, the total extra cost of using the

robot was €1456 per intervention. • The cost of the surgical supplies specifically required by conventional laparoscopy amounted to €1432, which is

significantly higher than that of the robotic supplies (€957, p=0.001). • Hospital costs were lower for robotically assisted cases (p<0.001) because these patients spent less time in intensive care

(ICU) (0.38 vs 0.85 days). • Patients were transferred to the ICU more often after having a laparoscopic procedure (27% of patients) than after

having a robotic procedure (13% of patients, p=0.0234). • Operating theater costs were higher in the case of the robotic strategy (p=0.004) because the procedure took longer to

perform. • The incremental cost of robotic procedures would decrease significantly with the number of procedures performed per

year: €1456 with 165 procedures, €1069 with 200 procedures, €703 with 250 procedures, and only €460 with 300 procedures.

Conclusion • The large initial investment involved in purchasing a robotic system can be partly offset by using it for more than 200 cases

per year. • Conventional laparoscopic hysterectomy is often too complex to be performed on some patients, such as obese

patients. The robotic system makes minimally invasive surgery an option for more patients. • As robotic surgery develops in fields where no other minimally invasive procedures are yet available, the clinical and

economic benefits as well as the advantages from the patients’ point of view may justify its widespread use. Limitations • This study was not randomized; thus, a center-related effect may have biased the results. • 4 of the 16 centers were accustomed to performing conventional laparoscopy and had just started using the robotic

approach; these surgeons were therefore at the beginning of the learning curve, which could explain the longer times spent in the operating theater.



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Overview • Retrospective analysis of 109 consecutive patients newly diagnosed with cervical cancer undergoing

of robotically-assisted radical hysterectomy (RRH) between July 2007 and January 2014 • 5 Belgian centers participated in the study; at each center, only one surgeon performed the

procedures using either the da Vinci S® or da Vinci Si® Surgical System. • Patient histology included squamous cell carcinoma (N=61), adenocarcinoma (N= 22),

adenosquamous (N= 8, endometrioid carcinoma (N= 2), and other types (N=16). • 21 patients received neoadjuvant chemotherapy (NACT) patients. 24 patients received

adjuvant therapy − 17 patients underwent radiochemotherapy − 7 underwent adjuvant radiation

Robot-Assisted Radical Hysterectomy in Cervical Carcinoma: The Belgian Experience

Segaert A, Traen K, Van Trappen P et al. Robot-Assisted Radical Hysterectomy in Cervical Carcinoma. Int J Gynecol Cancer. 2015;25(9):1690-1696. doi:10.1097/igc.0000000000000536

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FIGO Stage Distribution (N=109)

No. Patients

IA 9

IB1 71

IB2 4

IIA 11

IIB 13

Unknown 1

Operative Outcome (N=109)

Median (Range)

No. pelvic nodes 23 (6-70)

Estimated Blood Loss, mL

150 (15-1500)

Hospital stay, d 4.5 (3-19)

Operative time, min

281 (160-550)

Follow up, mo 27.5 (3-82)

Postoperative Complications

No. Patients

Urinary Retention 7

Urinary tract infection

8

Bleeding 4

Peritonitis 2

Compartment syndrome

1

Vesicovaginal fistula

2

Total postoperative complications

24


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Results • There were no conversions to laparotomy. • Intraoperative complications occurred in 5 patients: 2 instances of bladder lesion, 1 serosal lesion on the bowel,

and 2 instances of bleeding in the right obturator fossa (EBL 500 mL) and left iliac region (EBL 1500 mL). • There were no deaths due to complications. Twenty-four postoperative complications were recorded the first 30

postoperative days. • The median hospital stay was 4.5 days. • There were 3 patients with positive resection margins: 2 patients with stage IIB tumors and who received NACT,

and 1 patient with stage IIA1 tumor and who did not receive NACT. Parametrial invasion was found in 9 patients. • The median follow-up time was 27.5 months (range 3–82 months). • The median time to recurrence was 1.8 years (range 0.3–6.1 years). Recurrence occurred in 18 patients (16.5%): 1

patient with stage IA cancer, 11 with stage IB1, 1 with stage IB2, 2 with stage IIA, and 3 with stage IIB.

Conclusion • This study confirms the feasibility and safety of RRH in not only cervical cancer stages IA to IB1, but also after NACT

in stages IB2 to IIB.

Limitations • The oncological outcomes may not be an accurate representation of all surgeons’ experiences with RRH in

cervical cancer cases. • Survival statistics from RRH for cervical cancer are scarce, with small patient cohorts and limited follow-up time. • One of the five study centers recorded only three cases, which may not provide an accurate representation of

that center’s experience.



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Overview • Study to assess the direct costs for three surgical approaches in uterine cancer and the

cost-effectiveness of incorporating robotic-assisted surgery

• Direct cost for 436 procedures (132 laparoscopic, 262 robotic, 42 laparotomy) done for newly diagnosed uterine cancer at Memorial Sloan-Kettering from January 2009 through December 2010 was analyzed for all aspects of surgical care up to 6 months after discharge

• Performed cost modeling to estimate the mean cost of surgical care for patients presenting from 2007-2010 at Memorial Sloan-Kettering as well as a theoretical distribution based on planned laparoscopy, robotic, and laparotomy in this time period

Cost-Effectiveness Analysis of Robotically-Assisted Laparoscopy for Newly Diagnosed Uterine Cancers

Leitao, M. M., Jr., et al. (2014). "Cost-Effectiveness Analysis of Robotically Assisted Laparoscopy for Newly Diagnosed Uterine Cancers." Obstetrics and Gynecology 123(5): 1031-1037.

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Results • The mean amortized cost total was $3,157 more for robotic compared with laparoscopic cases; $996 less for robotic cases

compared with laparotomy cases

• The mean nonamortized cost total was $178 more for robotic compared with laparoscopic cases; $3,966 less for robotic compared with laparotomy cases.

2009-2010 PLANNED SURGICAL APPROACH

Robotic vs. Laparoscopic Difference P-Value

Robotic vs. Laparotomy Difference

P-Value

Amortized Total Cost +$3,157 0.05 -$996 0.6

Nonamortized Total Cost +$178 0.9 -$3,966 .03

Methods • Amortized costs include total costs and equipment costs:

– Robotic - 3 dual-console da Vinci Si® platforms and 5 years of service contracts, based on total of 751 cases in 2009 and 886 in 2010

– Laparoscopic - Standard laparoscopic capital and instrumentation costs

• Nonamortized costs include total costs (perioperative costs, postoperative stay and postoperative costs 6 months following surgery) minus equipment costs


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020406080

100

2007 2008 2009 2010

%

Memorial Sloan Kettering 2007-2010

020406080

100

2007 2008 2009 2010

%

Modeled United States 2007-2010

Surgical Approach

From 2007 to 2010, the amortized total cost per patient at Memorial Sloan

Kettering increased by $940. Excluding capital equipment costs, the

mean nonamortized total cost per patient decreased by $725.

In the theoretical scenario for the United States, the amortized total cost per

patient decreased by $418. Excluding capital equipment costs, the

mean nonamortized total cost per patient decreased by $1,666.


Cost-Effectiveness Analysis of Robotically-Assisted Laparoscopy for Newly Diagnosed Uterine Cancers HC

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Conclusion • Cost of robotics must take into account how it affects the rate of laparotomy

• The enhancement of laparoscopic programs with the introduction of a robotic platform and a concomitant decrease in laparotomy rates leads to a cost neutralization of the robotic platform and potentially a cost savings overall.

• Laparoscopy is least expensive when including capital acquisition costs. Laparoscopy and robotic surgery are comparable if upfront costs are excluded.

Limitations • Non-randomized, retrospective data review from a single institution

• No risk-adjusted analysis as a result of a small number of planned laparotomies



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Overview • 146 patients treated at a single institution using robotic-assisted and laparoscopic approaches

(40 vs 146 patients), from Jan 2002 to Dec 2011. • This study compared the rates of intraoperative and postoperative complications of robotic surgery

and laparoscopy in the surgical treatment of endometrial cancer. • The same gynecologic oncology team, consisting of senior experienced surgeons, performed

all procedures.

Laparoscopy vs Robotics in Surgical Management of Endometrial Cancer: Comparison of Intraoperative and Postoperative Complications

PN1009695 Rev A

, 06/14

Seror, J. et al. (2014). "Laparoscopy vs Robotics in Surgical Management of Endometrial Cancer: Comparison of Intraoperative and Postoperative Complications." J Minim Invasive Gynecol 21(1):120-5.

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The above data on learning curve, provided directly by the lead author to ISI, suggest to him that the learning curve for robotic surgery had a positive impact on time spent in the OR.

*Average robotic time defined as time in the OR, from induction through suturing. Learning curve data provided directly to ISI by the lead author.

Conventional Laparoscopy (n=106)

dV Cohort (n= 40) p-value

Adhesiolysis 22 (20.7%) 13 (32.5%) .14 Hysterectomy with BSO 106 (100%) 40 (100%) - Pelvic lymphadenectomy 88 (83%) 32 (80%) 0.67 Para-aortic lymphadenectomy 11 (10.4%) 5 (12.5%) 0.77 Transfusion 0 0 - Hospitalization data mean (SD)

Time in operating room, min 268.07 (253.4-282.7) 313.59 (284.4-342.8) .003

Operative time, min 201.28 (195.4-225.1) 247.82 (220.8-274.8) .01 Hospital stay, days 7.15 (6.1-8.2) 6.9 (6.2-7.5) .78


1st-10th Cases 11th-20th Cases 21st-30th Cases 31st-40th Cases Average robotic time* across the learning curve 276.5 226.6 232 212.11


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PN1009695 Rev A

, 06/14

Complications Conventional Laparoscopy

(n=106) dV Cohort p-Value

Intraoperative 10 (9,4%) 0 .06

Early postoperative 12 (11.3%) 4 (10%) 1.00

Late postoperative 12 (11.3%) 6 (15%) .58

Intraoperative 10 (9,4%) 0 .06



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Results • No intraoperative complications occurred in the robotic group • Patients were comparable insofar as surgical history • Surgical procedures performed were similar in both groups • These results therefore led the authors to believe that conversions to laparotomy were related to the surgical

technique the patient received (conventional lap vs robotic)

Conclusion • This study presented the first 40 robotic cases performed in the institution. • The two groups were comparable for intraoperative and postoperative complication rates. • However, the authors stated their belief that conversions to laparotomy were related to the surgical

technique. (lap v robotic)

Limitations • No randomization • Retrospective study • Robotic procedures were limited by technical platform (S system) • No study of intraoperative blood loss • No specific data analysis of the obese population • Lap group larger than robotic group (106 vs 40 patients)


PN1009695 Rev A

, 06/14


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Overview • 192 patients were seen from June 2010 until December 2013

• This study aimed to assess the impact of robotics on the proportion of open laparotomies performed for endometrial cancer and to evaluate the impact of those rates on clinical and financial outcomes.

Introducing Robotics Reduces the Number of Laparotomies and Saves Money in a Tertiary Referral Endometrial Cancer Service

A Poster Session Presented at SERGS 2014 (This photograph is of the actual poster shown at SERGS in 2014.)

Thomas Ind, Marielle Nobbenhuis, “Introducing robotics reduces the number of laparotomies and saves money in a tertiary referral endometrial cancer service" Poster, SERGS 2014

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Open (Op) Straight Sticks (SS) Robot(Ro) Comparison P Value*

Ward/Clinic Costs (£) 3,739 1,889 1,428 Ro vs Op: <0.0001 Ro vs SS: 0.0009

Medical Staffing Costs(£) 2,185 2,272 1,998 Ro vs Op: 0.053 Ro vs SS: 0.04

Theatre Costs (£) 2,282 2,565 2,280 Ro vs Op: NS Ro vs SS: NS

Drugs/Pharmacy Costs (£) 201 101 119 Ro vs Op: <0.0001 Ro vs SS: NS

Blood Products Costs (£) 0 0 0 Ro vs Op: NS Ro vs SS: NS

Imaging Costs (£) 102 7 0 Ro vs Op: 0.0075 Ro vs SS: NS

Pathology Costs (£) 692 544 141 Ro vs Op: <0.0001 Ro vs SS: NS

Rehab Therapy Costs (£) 287 31 0 Ro vs Op: <0.0001 Ro vs SS: 0.0242

High Dependency Care Costs (£) 2,830 2,561 2,213 Ro vs Op: 0.0327 Ro vs SS: NS

Total Cost (£) 12,462 9,953 7,883 Ro vs Op: <0.0001 Ro vs SS: 0.0021

Cost Including Depreciation (£) 12,462 9,979 8,481 Ro vs Op: <0.0001 Ro vs SS: 0.0284

«The cost savings came from ward and rehabilitation» Data and conclusions shown are taken from the poster session accepted for presentation at the SERGS 2014 conference.

Costs of Primary Surgery for Endometrial Cancer by Surgical Route


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Open (Op) Straight Sticks (SS) Robot (Ro) Comparison P Value*

Operative Time (min) – Median (Range) 180 (75-430) 230 (78-585) 192 (130-306) Ro vs Op: NS

Ro vs SS: NS High Dependency Post Op Care - n/N 90/95 (94.7%) 62/77 (80.5%) 17/24 (70.8%) Ro vs Op: 0.0024

Ro vs SS: NS Estimated Blood Loss (ml) – Median (Range) 400 (50 - 3,700) 200 (50-850) 100 (0 - 250) Ro vs Op: <0.0001

Ro vs SS: 0.0158

Drop in Hb - (g/l) 23 (-8 - 58) 19 (-10 - 41) 17 (0 - 33) Ro vs Op: 0.0045 Ro vs SS:NS

Days Stay – Median (Range) 6 (3 - 26) 3 (1 - 11) 2 (1 - 4) Ro vs Op: <0.0001 Ro vs SS: 0.0031

Conversion to Laparotomy NA 14/77 (18.2%) 0/24 (0%) Ro vs SS: 0.0164

Any Complications 59/95 (62.1%) 23/77 (29.9%) 1/24 (4.2%) Ro vs Op: <0.0001

Ro vs SS: 0.0061 Urinary Tract Infections 30/95 (31.6%) 14/77 (18.2%) 0/24 (0%) Ro vs Op: 0.0004

Ro vs SS: 0.0164

Wound Infection 15/95 (15.8%) 4/77 (5.2%) 0/24 (0%) Ro vs Op: 0.0267

Ro vs SS: NS Blood Transfusion 36/95 (37.9%) 0/77 (0%) 1/24 (4.2%) Ro vs Op: 0.0006

Ro vs SS: NS Other Complications: 18/95 (18.9%) 11/77 (14.3%) 0/24 (0%) Ro vs Op: 0.012

Ro vs SS: 0.042

Introducing Robotics Reduces the Number of Laparotomies and Saves Money in a Tertiary Referral Endometrial Cancer Service Outcomes Following Primary Surgery for Endometrial Cancer by Surgical Route


Data and conclusions shown are taken from the poster session accepted for presentation at the SERGS 2014 conference.

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Conclusion • The data suggest a total cost savings for the trust after the introduction of robotics for

endometrial cancer surgery. • The savings came from costs during hospitalization and rehabilitation. • There was a reduction in laparotomies but no impact on straight stick surgery rate. • Length of stay was halved.

Limitations • Data and conclusions shown are taken from a poster session accepted for presentation at

SERGS 2014 based on an abstract submitted to the conference for consideration. • The results are from a retrospective study.



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Overview • Evaluates the effect on cost and patient outcomes of introducing a robotic surgery

program in gynecologic oncology

• Primary end points were to evaluate both the clinical and cost effectiveness of introducing a robotics program for the treatment of endometrial cancer

• 143 patients in the da Vinci cohort (2007-2010) are retrospectively compared to a historical cohort of 160 non-da Vinci patients (2003-2007; 133 via laparotomy and 27 via laparoscopy)

Outcomes and Cost Comparisons After Introducing a Robotics Program for Endometrial Cancer Surgery

Lau S, Vaknin Z, Ramana-Kumar AV, Halliday D, Franco EL, Gotlieb WH. Outcomes and cost comparisons after introducing a robotics program for endometrial cancer surgery. Obstet Gynecol. 2012 Apr;119(4):717-24.

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*Historic cohort includes consecutive patients who underwent both open and laparoscopic surgery. Consecutive patients before robotics program (2003-2007), consecutive da Vinci patients (2007-2010).

Historic Cohort* (n=160)

dV Cohort (n= 143) p-value

Median operation time (min) 206 233 <.001

Complications (%) 42 13 <.001

Median blood loss (mL) 200 50 <.001

Hospital stay (days) 5 1 <.001



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Historic Cohort dV Cohort p-value

Hospital accommodations $6,623 $2,658 <.001

OR Costs $237 $2,977 <.001 Overall Costs* Without amortization $10,368 $7,644 <.001

With amortization $10,368

$8,370

.002

Average perioperative costs before and after introduction of a robotics program:

Data are mean Canadian dollars

*The costs included surgery supplies, central supplies (outside the OR), surgery procedure (time-based and physician cost), radiology, pharmacy, laboratory, anesthesia costs, and room and board

*The amortization cost of the da Vinci Surgical System was calculated on the basis of the sum of the cost of the robotic system and the service cost of 10% per year for 10 years divided by the total number of cases expected to be performed during that period ( i.e., 5,200 patients, $726 Can. per patient) based on the current case load of two cases per day.



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Conclusion • The introduction of a da Vinci® program increased the rate of minimally invasive surgery for

endometrial cancer patients from 17% to 98% in 2 years • Patients undergoing da Vinci procedures had longer operating times, but fewer adverse

events, lower estimated median blood loss, and shorter median hospital stay • The overall hospital costs were significantly lower for robotics compared with the historical

group—even when acquisition and maintenance cost were included

Limitations • Retrospective data review


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Introduction of a Computer-Based Surgical Platform in the Surgical Case of Patients with Newly Diagnosed Uterine Cancer: Outcomes and Impact on Approach

Overview • Assessed the efficiency and effectiveness of introducing robotic surgery in the treatment of uterine

cancer in terms of operative time, patient outcomes, and the reduction of laparotomy • 752 patients identified from May 2007 to December 2010, the planned approach was:

– 103 laparotomy (14%) – 302 laparoscopic surgery (40%) – 347 robotic surgery (46%)

Mario M. Leitao, Jr et al. Introduction of a computer-based surgical platform in the surgical care of patients with newly diagnosed uterine cancer: outcomes and impact on approach. Gynecol Oncol. 2012 May; 125(2): 394–399. Published online 2012 February 1. doi: 10.1016/j.ygyno.2012.01.046

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Planned approach 2007 2008 2009 2010 p-Value

(2007 vs. 2010) N 108 198 234 212

Lap 68% 46% 33% 26% <0.001

dV 8% 36% 56% 64%

Open 24% 16% 11% 9%

Final approach* MIS 61% 72% 81% 82% <0.001

Open 39% 28% 19% 18%

*For this analysis, MIS cases are lap or dV cases not requiring conversion to open and open cases include both the planned open and MIS cases converted to open.

Rates of laparotomy over time:


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Conclusion • Both MIS approaches offer excellent patient outcomes (low rates of conversion to open, low

complications) • Length of postoperative hospital stay was significantly shorter in the da Vinci® cohort (p<0.001) • In cases in which a comprehensive pelvic and aortic LND was performed, the operative

times were the same between da Vinci and lap cases after excluding the first 20 cases

Limitations • Retrospective, non-randomized study

Financial Disclosure Dr. Leitao has received compensation from Intuitive Surgical for consulting and/or educational services.



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Overview • Examines outcomes from the first 1,000 women who underwent da Vinci (dV)

hysterectomy at a tertiary care center in Seattle, WA

• 377 women who underwent dV hysterectomy for endometrial cancer staging (ECS) were compared with a historical data set of 131 who underwent ECS via laparotomy

• Data collected included age, BMI, number of previous abdominal surgeries, EBL, operative times (OT), pathologic findings such as lymph node count (LN), major and minor surgical complications, and length of stay (LOS)

• Resident and fellow involvement in cases was examined

Surgical Outcomes in Gynecologic Oncology in the Era Robotics: Analysis of First 1000 Cases

Paley PJ, Veljovich DS, Shah CA, Everett EN, Bondurant AE, Drescher CW, Peters WA 3rd. Surgical outcomes in gynecologic oncology in the era of robotics: analysis of first 1000 cases. Am J Obstet Gynecol. 2011. Jun;204(6):551.e1-9. Epub 2011 Mar 16.

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BMI, complications, conversions and cuff dehiscence by year:

2006-2007 (T1) n=149

2007-2008 (T2) n=323

2008-2009 (T3) n=528

BMI (range) 26.5a

(17.4-49.4) 29.5b

(14.6-69.2) 30.1c

(15.9-70.1)

Major Complications (%) 8.7 (n=13) 4.3 (n=14) 5.7 (n=30)

Conversions (%) 4.0 (n=6) 2.5 (n=8) 2.8 (n=15)

Cuff Dehiscence (%) 2.6 0.72 0.22

a T1 vs. T2; p=0.01 b T2 vs. T3; p=0.037 c T1 vs. T3; p=0.0001 p values not provided for Major Complications, Conversions or Cuff Dehiscence



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a Includes infection, wound dehiscence, anemia requiring transfusion, pulmonary, cystostomy, myocardial infarction, atrial fibrillation, acute renal failure and ureteral injury. aIncludes infection, wound dehiscence, anemia requiring transfusion, pulmonary, cystostomy, myocardial infarction, atrial fibrillation, acute renal failure and ureteral injury.

da Vinci (n=377)

Laparotomy (n=131) p-value

Age (yrs) 62.1 63 0.08

BMI (kg/m2) 31.3 32.2 0.47

Surgical Time (mins) 184 139 <0.0001

EBL (mL) 46.9 197.6 <0.0001

Node Counts (n) 15.4 13.1 0.007

LOS (days) 1.4 5.3 <0.0001

Major Complications (%) 6.4 (n=24) 20.6 (n=27) <0.0001

Major complicationsa, Obese subset (n=5/136) 3.7% (n=15/47) 31%

<0.0001



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Conclusion • Despite a steady rise in BMI, the authors found no concomitant rise in major complications or conversions,

and a steady decline in the rate of vaginal cuff dehiscence • There were no significant differences in total complications or conversions to laparotomy when residents and

fellows participated • Compared to the historical open cohort, women who underwent robotic surgery experienced:

– Lower blood loss – Shorter hospitalization – Fewer major complications – Higher lymph node counts

Limitations • Retrospective • Nonrandomized

Financial Disclosure Dr. Paley has received compensation from Intuitive Surgical for consulting and/or educational services.



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Overview • From January 2006 to May 2010, 294 patients with cervical cancer were studied after

radical hysterectomy procedures – 73 (24.8%) robot-assisted – 46 (15.6%) laparoscopic-assisted vaginal – 175 (59.5%) abdominal

• Analyzes perioperative outcomes and survival data

Robot-Assisted Radical Hysterectomy – Perioperative and Survival Outcomes in Patients for Cervical Cancer Compared to Laparoscopic and Open Radical Surgery

Gortchev G, Tomov S, Tantchev L, Velkova A, Radionva Z. Robot-assisted radical hysterectomy – perioperative and survival outcomes in patients with cervical cancer compared to laparoscopic and open radical surgery. Gynecol Sug, June 2011

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dV (n=73) Lap-Assisted Vaginal (n=46)

Abdominal (n=175) P Value

Mean Age (years) 46.0 ± 11.2 42.5 ± 9.9 49.0 ± 11.0 0.001**

Mean Operative Time (min) 152.2 ± 26.5 232.1 ± 61.7 168.2 ± 31.1 0.001**

Mean Hospital Stay (days) 4.1 ± 0.7 4.8 ± 0.5 9.6 ± 1.0 0.001*

Complication Rates 4.1% 2.2% 5.1% NS

Follow-up period (days) 316.3 ± 192.0 808.3 ± 385.3 1,531.6 ± 612.2 0.001+

*Compared to ARH **Compared to LARVH and ARH + Compared to LARVH



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Conclusion • Robotic-assisted radical hysterectomy is a reliable procedure with proven advantages

compared to lap-assisted radical vaginal hysterectomy and abdominal radical hysterectomy: – Shorter operative time – Shorter hospital stay

Limitations • Non-randomized • Retrospective • Single-institution study



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Overview • Single-center study comparing the learning curve and clinical outcomes for three surgical

methods of endometrial cancer management: – 36 total abdominal hysterectomy with lymphadenectomy (TAH) – 56 total laparoscopic hysterectomy with lymphadenectomy (TLH) – 56 robotic-assisted hysterectomy with lymphadenectomy (dVH)

• Surgical outcomes for the 3 procedure approaches were analyzed

Learning Curve and Surgical Outcome for Robotic-Assisted Hysterectomy with Lymphadenectomy: Case-Matched Controlled Comparison with Laparoscopy and Laparotomy for Treatment of Endometrial Cancer

Peter C. Lim, Elizabeth Kang, Do Hwan Park. Learning curve and surgical outcome for robotic-assisted hysterectomy with lymphadenectomy: case-matched controlled comparison with laparoscopy and laparotomy for treatment of endometrial cancer. J Minim Invasive Gynecol. 2010 Nov-Dec; 17(6): 739–748. doi: 10.1016/j.jmig.2010.07.008

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Open (TAH) (n=36)

Laparoscopy (TLH)

(n=56)

dV (dVH) (n=56)

Significance (dVH vs. TLH)

Mean age (years) 62.7 61.4 62.5 NS

Mean BMI (kg/m2) 28.9 28.2 30.4 NS

Mean EBL (mL) 266.0 209.1 89.3 Significant*

Mean operative (skin-to-skin) time (min) 136.9 192.3 162.5 Significant*

Mean LOS (days) 4.9 2.6 1.6 Significant*

Intraoperative complications (%) 0 12.5 0 Significant

Conversions to laparotomy (%) NA 7.1 1.7 NS

Mean total lymph nodes (n)1 55.8 45.1 26.7 Significant*

Pelvic nodes (n) 30.8 24.1 19.2 Significant*

Para-aortic nodes (n) 25.0 20.9 12.9 Significant**

Surgical outcomes during the learning curve for each respective procedures:

1 Authors’ reasons for lymph node count difference – (1) aortic lymphadenectomy performed for TAH and TLH to level of renal veins; for dVH, level dictated by intraoperative pathologic findings. (2) dVH lymph nodes removed in packets vs. piecemeal in TLH.

* dVH vs. open significant. TLH vs. open also significant. ** dVH vs. open significant. TLH vs. open NOT significant.



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dVH Operating Time TLH Operating Time TAH Operating Time

Operating time over time for each respective procedure:



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Conclusion • The learning curve for robotic-assisted hysterectomy with lymph node dissection seems to be easier

compared with that for laparoscopic hysterectomy with lymph node dissection for surgical management of endometrial cancer

• dVH patients experienced significantly better clinical outcomes compared to the TLH and TAH patients, in the following respects: – Shorter average length of stay – Lower average estimated blood loss – Low intraoperative complications rate (0%) – Conversion rate for dVH patients (1.7%) was lower than the conversion rate for TLH patients (7.1%, NS)

Limitations • Single institution study • Retrospective

Financial Disclosure: Dr. Lim has received compensation from Intuitive Surgical for consulting and/or educational services.



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Overview • Study to compare the adequacy and outcomes of surgical staging

for endometrial cancer in obese women (mean BMI of 40) by robotics or laparotomy

• 109 patients underwent surgery with the intent of robotic staging and were matched to 191 laparotomy patients

• Patient characteristics, operative times, blood transfusion rates, length of stay, complications and pathologic factors were collected and compared between robotic and laparotomy procedures

Comprehensive Surgical Staging for Endometrial Cancer in Obese Patients

Leigh G. Seamon, Shannon A. Bryant, Patrick S. Rheaume, Kristopher J. Kimball, Warner K. Huh, Jeffrey M. Fowler, Gary S. Phillips, David E. Cohn. Comprehensive surgical staging for endometrial cancer in obese patients: comparing robotics and laparotomy. Obstet Gynecol. 2009 July; 114(1): 16–21. doi: 10.1097/AOG.0b013e3181aa96c7

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dV (N=92)

Laparotomy (N=162) P value

Ave Age (yr) 58 62 0.003 Ave BMI 39.6 39.9 Matched Comorbidities >3 (%) 42.9 26.3 0.05 Previous Surgery (%) 50.5 62.6 0.04 EBL (ml) 109 394 <0.001 Total Lymph Node Count 24.7 23.9 - LOS (day) 1 3 <0.001 Wound Problems (%) 2 17 0.002 Complications (%) 11 27 0.003

Comprehensive Surgical Staging for Endometrial Cancer in Obese Patients


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Comprehensive Surgical Staging for Endometrial Cancer in Obese Patients Conclusion • Robotic surgery is feasible in obese women with endometrial cancer and may result in

comparable rates of surgical staging compared with laparotomy • Blood transfusion rate, length of stay, complications, and wound complications were

lower for robotic surgery compared to laparotomy • Lymph node harvest robotically was comparable with laparotomy even in an obese

patient population

Limitations • Limited sample size • Retrospective • Possible underrepresentation of complications • Unknown potential confounders • Study was not powered to detect lymph node count differences

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Overview • Compares Robotic-Assisted hysterectomy with staging to both traditional laparoscopy and

laparotomy in women with endometrial cancer

• First consecutive Total Robotic Assisted Hysterectomies (TRH) (June 2005 to December 2007) compared to historical cohorts for Total Abdominal Hysterectomies (TAH) and Total Laparoscopic Hysterectomies (TLH) from prior to implementing a robotics program (April 2000 to September 2004) – 103 Total Robotic-Assisted Hysterectomies – 138 Total Abdominal Hysterectomies – 81 Total Laparoscopic Hysterectomies

Hysterectomy with Staging for Endometrial Cancer: Robotic, Laparoscopy, Laparotomy

Boggess JF, Gehrig PA, Cantrell L, et al. A comparative study of 3 surgical methods for hysterectomy with staging for endometrial cancer: robotic assistance, laparoscopy, laparotomy. Am J Obstet Gynecol 2008;199:360.e1-360.e9.

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Open “TAH” (n=138)

Laparoscopy “TLH”

(n=81)

dV “TRH” (n=103)

p Value (lap vs. dV)

Mean age (years) 64.0 62.0 61.9 .95

Mean BMI (kg/m2) 34.7 29.0 32.9 .0008

Mean EBL (ml) 266.0 145.8 74.5 <.0001

Mean operative (skin-to-skin) time (min) 146.5 213.4 191.2 <.0001

Mean hospital stay (days) 4.4 1.2 1.0 .001

Mean total lymph nodes (n) 14.9 23.1 32.9 <.0001

Pelvic nodes (n) 11.5 17.4 20.5 .06

Para-aortic nodes (n) 3.0 6.3 12.0 <.0001

Complications (%) 29.7% 13.6% 5.8% <.0001

Conversions to laparotomy (%) N/A 4.9% 2.9% .7

Hysterectomy with Staging for Endometrial Cancer: Robotic, Laparoscopy, Laparotomy


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Hysterectomy with Staging for Endometrial Cancer: Robotic, Laparoscopy, Laparotomy Conclusion • The mean EBL, LOS and % overall complications were significantly lower in the da Vinci® cohort

compared to both the lap and open cohorts • The da Vinci cohort had significantly higher mean total lymph nodes collected than the other

two cohorts • The mean operative time was significantly lower in the da Vinci® cohort compared to the lap cohort • da Vinci total hysterectomy with staging appears to be a safe and effective surgical alternative for

patients with early-stage endometrial cancer

Limitations • Not randomized • Inability to examine long-term oncologic results due to recent incorporation of robotic technology

Financial Disclosure: Dr. Boggess has received compensation from Intuitive Surgical for consulting and/or educational services.


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Hysterectomy (Malignant): urinary tract injury, vaginal cuff problem (separation, adhesions, granulation tissue, infection, cellulitis, hematoma), bladder injury, bowel injury, vaginal tear or laceration, vaginal shortening, voiding dysfunction, fistula formation: vesicovaginal, rectovaginal.

Surgical Risks HC

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Serious complications may occur in any surgery, including da Vinci® Surgery, up to and including death. Examples of serious or life-threatening complications, which may require prolonged and/or unexpected hospitalization and/or reoperation, include but are not limited to one or more of the following: injury to tissues/organs, bleeding, infection and internal scarring that can cause long-lasting dysfunction/pain. Individual surgical results may vary. Risks specific to minimally invasive surgery, including da Vinci® Surgery, include but are not limited to, one or more of the following: temporary pain/nerve injury associated with positioning; a longer operative time, the need to convert to an open approach, or the need for additional or larger incision sites. Converting the procedure could result in a longer operative time, a longer time under anesthesia, and could lead to increased complications. Contraindications applicable to the use of conventional endoscopic instruments also apply to the use of all da Vinci instruments. You should discuss your surgical experience and review these and all risks with your patients, including the potential for human error and equipment failure. Physicians should review all available information. Clinical studies are available through the National Library of Medicine at www.ncbi.nlm.nih.gov/pubmed. Be sure to read and understand all information in the applicable user manuals, including full cautions and warnings, before using da Vinci products. Failure to properly follow all instructions may lead to injury and result in improper functioning of the device. Training provided by Intuitive Surgical is limited to the use of its products and does not replace the necessary medical training and experience required to perform surgery. Procedure descriptions are developed with, reviewed and approved by independent surgeons. Other surgical techniques may be documented in publications available at the National Library of Medicine. For Important Safety Information, indications for use, risks, full cautions and warnings, please also refer to www.davincisurgery.com/safety and www.intuitivesurgical.com/safety. Unless otherwise noted, products featured are available for commercial distribution in the U.S. For availability outside the U.S., please check with your local representative or distributor.

Important Safety Information HC

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DA VINCI® HYSTERECTOMY – BENIGN HB

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INDEX – Hysterectomy Benign STUDY MAIN

AUTHOR(S) YEAR

Multicenter Analysis Comparing Robotic-assisted, Open, Laparoscopic, And Vaginal Hysterectomies Performed By High-volume Surgeons For Benign Indications

Lim 2016

The Impact Of Robotics On The Mode Of Benign Hysterectomy And Clinical Outcomes Luciano 2015

Robotic Hysterectomy Using The Vessel Sealer For Myomatous Uteri: Technique And Clinical Outcome

Hoste, Van Trappen

2015

The Impact Of Different Surgical Modalities For Hysterectomy On Satisfaction And Patient Reported Outcomes

Pitter 2014

A Comparison Of Quality Outcome Measures In Patients Having A Hysterectomy For Benign Hysterectomy: Robotic Vs. Non-robotic Approaches

Martino 2014

Discharge Less Than 6 Hours After Robot-assisted Total Laparoscopic Hysterectomy – Is It Feasible?

Dinesen, Petersen 2014

Robot-assisted Laparoscopic Hysterectomy Vs Tradtional Laparoscopic Hysterectomy: Five Metaanalyses

Scandola 2011

Increasing Minimally Invasive Hysterectomy: Effect On Cost And Complications Jonsdottir 2011

Robotically Assisted Hysterectomy In Patients With Large Uteri- Outcomes In Five Community Practices

Payne 2010

Perioperative Outcomes Of Robotically Assisted Hysterectomy For Benign Cases With Complex Pathology

Boggess 2009

A Comparison Of Total Laparoscopic Hysterectomy To Robotically Assisted Hysterectomy: Surgical Outcomes In A Community Practice

Payne 2008

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Overview • A retrospective cohort study of a Michigan multicenter prospective database . Data was abstracted and analyzed from January

1, 2013, through July 2, 2014. • Includes data from an all-payer quality and safety database maintained by the Michigan Surgical Quality Collaborative (a large

sample of hysterectomies from a statewide database that includes all payer groups, academic, and community hospitals) • The primary objective of the study was to evaluate the incidence and risk factors for conversion to laparotomy for both traditional

laparoscopic and robotic hysterectomy performed for benign indications using a statewide multicenter prospective database • The secondary objective was to determine differences in 30-day outcomes of women who had conversion to laparotomy. This

information will enhance risk stratification and improve preoperative planning and patient selection for hysterectomy • Women with a preoperative indication of cancer or obstetric indications were excluded. • A logistic regression model was used to calculate odds of conversion using patient preoperative and intraoperative attributes.

− Covariates were included in the multivariable model with accounting for clustering by site using robust standard errors − Covariates: surgeon volume, surgical approach (lap vs. robotic-assisted), patient age, BMI, alternative treatment before

hysterectomy, indication for hysterectomy, presence of adhesions, presence of endometriosis, cancer on final pathology, and specimen weight

• During the study period, 6,992 cases were eligible to be included in the analysis of women underwent an attempted laparoscopic hysterectomy (2,464 traditional laparoscopic, 4,528 robotic-assisted)

Risk Factors and Outcomes for Conversion to Laparotomy of Laparoscopic Hysterectomy in Benign Gynecology

Lim CS, et al, Risk Factors and Outcomes for Conversion to Laparotomy of Laparoscopic Hysterectomy in Benign Gynecology, Obstetrics & Gynecology (2016) DOI: 10.1097/AOG.0000000000001743

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Adjusted OR (95% CI) P

Age <40 40 to <60 60+

Referent

1.55 (1.03–2.31) 1.83 (1.00–3.35)

.034

.050

Nonwhite vs. white 1.07 (0.76–1.52) .694 Surgeon Volume

Lower two tertiles Top tertile

Referent

0.66 (0.47–0.92)

.015 Robotics vs. traditional laparoscopy 0.14 (0.07–0.25) <.001 BMI

Less than 30 30 or greater

Referent

1.62 (1.24–2.13)

<.001 Indications for hysterectomy (no)

Pelvic mass Yes

Pelvic organ prolapse Yes

Referent

1.64 (1.00–2.69)

0.40 (0.19–0.83)

.050

.015 Adhesions

None or mild Moderate Severe

Referent

2.49 (1.58–3.92) 8.07 (5.60–11.62)

<.001 <.001

Specimen Weight (g) <250 250-499 500-999 1,000+

Referent

2.97 (2.12–4.16) 4.88 (2.78–8.58)

5.15 (2.15–12.36)

<.001 <.001 <.001

Multivariable Logistic Regression of Risk Factors for Conversion of Laparoscopic Hysterectomy to Laparotomy

OR, odds ratio; CI, confidence interval; BMI, body mass index.

The significant risk factors for conversion with multivariate logistic regression modeling were: • Age older than 40 years and

60 years or younger • BMI greater than or equal to 30 • Preoperative indications of

pelvic mass • Presence of moderate or severe

adhesions • Specimen weight greater than 250 g.

The factors most strongly associated with decreased odds of conversion in the multivariate model were: • Having a robotic-assisted procedure • Having a high-volume surgeon.


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Results • 6,992 women underwent an attempted laparoscopic hysterectomy with 3.93% (n=275) converted to laparotomy. • After adjusting for socioeconomic differences, hysterectomy indication, and intraoperative factors, there were decreased odds of conversion to

laparotomy with use of robotic-assisted laparoscopy compared with traditional laparoscopy, with a predicted risk of conversion of 0.8% compared with 5.4% (P<.001).

• Compared with those who underwent traditional laparoscopy, the group of patients undergoing robotic-assisted laparoscopic hysterectomy had characteristics associated with higher surgical complexity, with statistically significantly higher BMIs and more frequent removal of the cervix and presence of endometriosis.

• High-volume surgeons were less likely to convert to laparotomy compared with low and medium volume surgeons, with a predicted risk of conversion of 1.4% compared with 2.25% (P=.015).

• Study identified a significant correlation between use of robotic-assisted surgery and surgical volume with a significantly greater proportion of high-volume surgeons using the robotic platform (72.02%) compared with the low-volume surgeons (49.09%, P<.001).

• Even among high-volume surgeons, the odds of conversion was lower with the robotic procedure (7.54% compared with 1.46%, P<.001; adjusted OR 0.13, 95% CI 0.06–0.27), even when controlling for other factors including uterine weight and adhesive disease.

• Conversion was associated with moderate or severe adhesive disease and increasing specimen weight. Conversion was associated with increased rates of surgical site infection, blood transfusion, severe sepsis, and reoperation.

Conclusion • This analysis demonstrates that conversion to laparotomy is associated with increased odds of postoperative morbidity, and robotic assistance and

surgeon volume are strongly associated with decreased odds of conversion.

Limitations • It is difficult to differentiate reasons of conversions in this database (result of an adverse, emergent event and those without complication and related to

surgeon judgment). • Inherent limitation of the sampling methodology, which captures a random sample of patients at each institution and not every patient for each surgeon • Surgeon skill and decision-making cannot be ascertained from a surgical database, and this analysis is limited to the available variables and cases

included in the Michigan Surgical Quality Collaborative database • The population and practice patterns in Michigan may not be applicable to other regions

Financial disclosure • None



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Overview • This analysis compared 30-day outcomes from consecutive, robotic-assisted procedures performed by

high-volume surgeons (≥60 prior procedures) at nine centers with records from the Premier Perspective database for abdominal, vaginal, and laparoscopic procedures performed by high-volume surgeons (≥60 prior procedures ) from January 1, 2012 to September 30, 2013.

• Data from 2300 robotic-assisted, 9745 abdominal, 8121 vaginal, and 11952 laparoscopic hysterectomies were included.

Multicenter Analysis Comparing Robotic, Open, Laparoscopic, and Vaginal Hysterectomies Performed by High-Volume Surgeons for Benign Indications

Lim PC, et al, Multicenter analysis comparing robotic, open, laparoscopic, and vaginal hysterectomies performed by high-volume surgeons for benign indications, Int J Gynecol Obstet (2016), http://dx.doi.org/10.1016/j.ijgo.2015.11.010

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Robotic-Assisted (n = 2300)

Abdominal (n = 9745)

Vaginal (n = 8121)

Laparoscopic (n = 11952)

Age 49.3 ± 11.5 46.7 ± 10.7* 48.7 ± 13.3* 43.9 ± 9.4*

Adhesive disease 431 (18.7%) 2,573 (26.4%)* 106 (1.3%)* 1,427 (11.9%)* Large uterus (>250g) 366 (15.9%) 368 (3.8%)* 589 (7.3%)* 1,671 (14%)* Concomitant Pelvic floor repair/reconstruction 732 (31.8%) 677 (6.9%)* 1785 (22.0%)* 634 (5.3%)*

Intraoperative complications 17 (0.7%) 174 (1.8%)* 142 (1.8%)* 142 (1.2%) Postoperative complications 131 (6.3%) 2,047 (21%)* 1,314 (16.2%)* 1,953 (16.3%)* Conversion to open surgery 2 (0.1%) NA 1 (0.0%) 11 (0.1%) Inpatient length of stay (days) 1.37 ± 1.1 3.0 ± 1.6* 1.9 ± 1.0* 1.7 ± 1.2* Hospital readmission (related to index surgery) 28 (1.3%) 340 (3.5%)* 130 (1.6%) 186 (1.6%)

Reoperation rate 17 (0.8%) 187 (1.9%)* 84 (1.0%) 118 (1.0%)

In this study , two sided p < 0.05 was considered significant *Indicates Statistically significant difference (p<0.05) versus robotic-assisted hysterectomy


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Results • Patients who underwent robotic-assisted hysterectomy were generally more complex; they were older, had higher rates of adhesive

disease, and had higher rates of large uteri than patients in the other cohorts. The robotic surgery patients also had a higher rate of concomitant procedures, including pelvic-floor repair and reconstruction.

• Among the inpatients, the mean length of hospital stay was shorter for the robotic-assisted group than the open, vaginal, and laparoscopic groups.

• The robotic-assisted cohort experienced significantly fewer intraoperative complications than the abdominal and vaginal cohorts, and experienced significantly fewer postoperative complications compared with all other cohorts.

• Significantly lower reoperation rates and hospital readmissions were observed in the robotic cohort compared with the abdominal cohort.

Conclusion • When performed by gynecologic surgeons with relevant high-volume experience, robotic-assisted benign hysterectomy provided

improved outcomes compared with abdominal, vaginal, and laparoscopic hysterectomies.

Limitations • Retrospective data review—missing data is a common, inherent limitation of retrospective data collection • The Premier database relies on ICD-9-CM diagnostic and procedure codes; there is a potential for miscoding. • If patients were readmitted to non-Premier hospitals, patient readmission data could have been lost, which raises the potential for

under-reporting. • The length of stay for outpatients was not available in the Premier database.

Financial disclosure • This study was funded by Intuitive Surgical for independent research and editorial support • Dr. Lim, Dr. Crane, Dr. English, Dr. Farnam, Dr. Garza, Dr. Winter, and Dr. Rozeboom have received compensation from Intuitive Surgical for consulting

and/or educational services.



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Overview • Clinical outcomes and incidence of complications were compared for benign

hysterectomies done via vaginal, abdominal, laparoscopy and robotic-assisted approaches

• In the Premier Perspective Database, 156 institutions that offered all four hysterectomy approaches from January 1, 2005 - December 31, 2010 were included in the analysis. 289,875 benign hysterectomies were identified

• All hysterectomies for gynecologic malignancies were excluded

The Impact of Robotics on the Mode of Benign Hysterectomy and Clinical Outcomes

Anthony A. Luciano, MD; Danielle E. Luciano; Jessica Gabbert, PhD; Usha Seshadri-Kreaden, MSc

Luciano AA, Luciano DE, JG, USK. The Impact of Robotics on the Mode of Benign Hysterectomy and Clinical Outcomes. Int J Med Robotics Comput Assist Surg. (2015) E-Publication DOI: 10.1002/rcs.1648

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Total Benign Hysterectomy (n = 289,875)

Robotic (n = 20,781)

Laparoscopic (n = 78,148)

Vaginal (n = 52,635)

Abdominal (n = 138,311)

Comorbidities 21.6% 15.2% 11.0% 16.9%

Uteri >250g 7.4% 5.5% 2.1% 1.6%

Morbid Obesity 4.9% 2.4% 1.5% 5.1%

Outpatient Hysterectomy 36.2% 33.4% 15.0% 0%

Complication Rate 14.8% 18.6% 16.2% 28.9%

Conversion Rate 2.5% 7.2% 0.04% -


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Total Benign Hysterectomy (n = 289,875)

Robotic (n = 20,781)

Laparoscopic (n = 78,148)

Vaginal (n = 52,635)

Abdominal (n = 138,311)

Average Surgery Time (Hours) 3.39 2.74 2.17 2.46

0123456789

10

Surgery Time(Hours)

Large Uterus(% of Patients)

Conversion Rate(%)

1-25 26-50 51-75 76-100 101-125 126-150Robotic Case


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Conclusion • During the study period, abdominal cases decreased (60-33%) and minimally invasive approaches

increased (40-67%) • Robotic surgery had the lowest complication rate across all modalities, however had the longest

operative time • Robotic surgery times and conversion and complication rates improved with experience, even with

increasing case complexity • Robotics was successfully incorporated without jeopardizing patient outcomes and increased the

overall use of minimally invasive approaches

Limitations • Restricting the analysis to hospitals with a robotic system may have selected hospitals that promote high

technology and minimally invasive surgery, which could result in different perioperative outcomes from hospitals that do not promote or specialize in these approaches

Financial Disclosure Dr. Luciano has received compensation from Intuitive Surgical® for consulting and/or educational services.



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Overview • The aim of this study was to report the clinical experience with the EndoWrist® One Vessel

Sealer during robotic hysterectomy in patients with uterine myomas.

• The study focused on a retrospective cohort series of the first 50 consecutive patients with myomatous uteri undergoing da Vinci Hysterectomy between September 2012 and May 2015 at AZ Saint-Jan Hospital Bruges (Belgium).

• The console and total (skin-to-skin) operative times, as well as a variety of pre-operative surgical outcomes, were prospectively recorded.

• In addition, the learning curve was evaluated.

Robotic Hysterectomy Using The Vessel Sealer For Myomatous Uteri: Technique and Clinical Outcome

Hoste G, Van Trappen, P. Robotic hysterectomy using the Vessel Sealer for myomatous uteri: technique and clinical outcome. European Journal of Obstetrics & Gynecology and Reproductive Biology 2015;194:241-244. http://dx.doi.org/10.1016/j.ejogrb.2015.09.030

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Robotic Hysterectomy Using The Vessel Sealer For Myomatous Uteri: Technique and Clinical Outcome The effect of learning, body mass index, uterine weight and size on the total operative time of robotic surgery, using the EndoWrist® One Vessel Sealer, for benign hysterectomy

Total Operative Time (skin to skin) <= 100 min (N=19)

Total Operative Time (skin to skin) > 100 min (N=31) p Value

Learning Curve

Cases 1-10 0 10 0.008

Cases 11-50 19 21 0.008

Body Mass Index

<= 30 16 26 1

>30 3 5 1

Uterine Weight

<=250 gr 9 9 0.37

>250 gr 10 22 0.37

Uterine Size

<= 12 weeks 14 15 0.14

>12 weeks 5 16 0.14


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Results • After an initial learning curve of the first 10 cases, the median total (skin-to-skin) operative time dropped significantly from 158

to 105 minutes (p=0.008). • Outliers in operative time were due to extensive adhesions, difficult location of a fibroid (such as in the broad ligament), or

fibroid diameter >10 cm. • Body mass index, uterine weight, and uterine size had no statistically significant effect on the median total operative time. • There were 3 intra-operative minor complications consisting of small bladder lesions (2–3 mm) in cases of bladder adherence

to the uterus because of large anterior fibroids and/or a history of repetitive caesarean sections. In addition, there were 2 postoperative complications - one urinary tract infection and one vaginal cuff hematoma.

• Median blood loss during surgery was 63 mL in all 50 cases (range: 0–400 mL). Conclusion Using the EndoWrist® One Vessel Sealer in da Vinci Hysterectomy for myomatous or large uteri did not affect: • Operative time for this procedure

− The median total operative time (108 min) was comparable to or less than those published in earlier reports • The learning curve

− The learning curve of 10 cases was similar to those published in previous reports • Median blood loss.

− Median blood loss was low in this study (63 ml) Limitations • Single surgeon at a single center • Small sample size • Previous experience in laparoscopic surgery in gynecology may have had an impact on the (short) learning curve observed • Furthermore, the synergy of one single primary surgeon with a dedicated surgical team could have contributed to increased

efficacy

Robotic Hysterectomy Using The Vessel Sealer For Myomatous Uteri: Technique and Clinical Outcome


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Overview • The objective of this study was to identify differences in patient satisfaction and recommendations,

stratified by approach to a hysterectomy

• 6,262 women met the study criteria – all were members of an online hysterectomy support community and had undergone a benign hysterectomy

• The approach to hysterectomy varied in the study population:

The Impact of Different Surgical Modalities for Hysterectomy on Satisfaction and Patient Reported Outcomes


Michael C Pitter, MD; Christopher Simmonds; Usha Seshadri-Kreaden, MS; Helen B Hubert, MPH, PhD

― 41.74% abdominal (2,614/6,262) ― 10.64% vaginal (666/6,262)

― 27.42% laparoscopic (1,717/6,262) ― 1.26% single-incision laparoscopic (79/6,262)

― 18.94% robotic (1,186/6,262)

Pitter MC, Simmonds C, Seshadri-Kreaden U, Hubert HBThe Impact of Different Surgical Modalities for Hysterectomy on Satisfaction and Patient Reported OutcomesInteract J Med Res 2014;3(3):e11URL: http://www.i-jmr.org/2014/3/e11DOI: 10.2196/ijmr.3160PMID: 25048103PMCID: 4129130

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Percent of Hysterectomy Patients “Extremely Satisfied” with Surgical Experience

2008-2013

Percent of Hysterectomy Patients “Extremely Satisfied” with Pain & Discomfort After Surgery

2008-2013

Findings indicated that there was less overall satisfaction in the abdominal group

The survey measured women’s satisfaction with their procedure, the level of pain and discomfort they experienced, and the reported time it took respondents to return to normal activities, such

as walking, driving and going back to work.

41% 48% 50%

56%

17%

28% 26%

35%


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64% less likely

Abdominal

64% more likely

Robotic

Patients who had an abdominal hysterectomy were significantly less likely to recommend that approach or choose it again than patients who had one of the minimally invasive procedures.

Likelihood of Patient Choosing the Same Surgery Again

Likelihood of Patient Recommending Same Surgery to Someone Else


71% less likely

Abdominal

2X more likely

Robotic

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“Results from our survey reinforce the importance of patient satisfaction and time to return to normal activities when evaluating the cost-benefit of different surgical approaches.”

- Michael Pitter, MD

Significant Independent Predictors of Patient Experience after Hysterectomy



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Conclusion • Women who had robotic-assisted surgery:

― Reported significantly higher overall satisfaction

― Would recommend the technique to others

― Said they would choose robotic-assisted surgery again

• Women who had open hysterectomy:

― Were less likely or unlikely to recommend the same approach

― Reported they would not choose the same technique again

• Results also showed that between 2001 and 2013, rates of open surgery for hysterectomy went from 68.2% to 24.4%

Limitations • Retrospective, web-based study

• Answers were self-reported by patients and may have been years after surgery

Financial Disclosure • Dr. Pitter has received compensation from Intuitive Surgical for consulting and/or educational services.



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Overview • 2,554 patients treated at a single institution for benign disease, using robotic-assisted and

non-robotic approaches, from Jan 2008 to Dec 2012

• This retrospective study assesses procedure-related readmissions within 30 days after discharge for patients who had a hysterectomy for benign disease

• Secondary outcome quality measures were cost, estimated blood loss, length of stay, and sum of costs due to readmission

A Comparison of Quality Outcome Measures in Patients Having a Hysterectomy for Benign Hysterectomy: Robotic vs. Non-Robotic Approaches

Martino, Martin A. et al. A Comparison of Quality Outcome Measures in Patients Having a Hysterectomy for Benign Disease: Robotic vs. Non-robotic Approaches. Journal of Minimally Invasive Gynecology, 2014, Volume 21 , Issue 3 , 389 - 393

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Robotic-assisted (n = 601)

Laparoscopic (n = 427)

Abdominal (Open)

(n = 1,194)

Vaginal (n = 332)

Total Readmissions < 30 days (Total No.) 1.00% (6)

2.58% (11)*

3.52% (42)*

2.41% (8)*

Mean Estimated Blood Loss (mL) 108.2 315.08* 318.8*

340.8*

Mean Length of Stay (min) 1570.3 3038.5* 3440.5* 3789.2*

Total Readmission Cost (adjusted for inflation to 2012) $32,946 $50,290 $328,230 $51,264

*p < 0.05 versus robotic-assisted, achieving statistical significance


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Conclusion • Women undergoing robotic-assisted hysterectomy have a significantly lower chance of readmission at

<30 days compared with the other three cohorts • Robotic-assisted surgeries resulted in significantly lower estimated blood loss and length of stay • A significant cost savings related to readmissions was identified in the robotic group when compared to non-

robotic approaches • Center for Medicare/Medicaid Services has identified “readmissions at <30 days” as a major source of

health care expenditures

Limitations • Retrospective data review • Single institution experience • Inability to account for patients who were readmitted to outside hospitals (though the authors state that this

finding was expected to be similar for all 4 cohorts)

Financial Disclosure Dr. Martino has received compensation from Intuitive Surgical® for consulting and/or educational services.



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Overview • This study tested the feasibility of a fast-track program in which patients were discharged from a Danish day

care unit within six hours after robotically-assisted total laparoscopic hysterectomy (RTLH).

• All patients who were scheduled for a total laparoscopic hysterectomy (TLH) were candidates for the RTLH fast-track program. Exclusion criteria were an ASA status of III and higher, and patient age greater than 80 years. All surgeons were fellowship-trained gynecologic oncologists.

• 22 patients were enrolled. The RTLH was combined with bilateral removal of the adnexa in all patients except one.

Discharge Less Than 6 Hours After Robot-Assisted Total Laparoscopic Hysterectomy – Is It Feasible?

Dinesen J, Hessellund B, Petersen L. Discharge less than 6 hours after robot-assisted total laparoscopic hysterectomy—is it feasible? Gynecol Surg. 2014;12(1):77-80. doi:10.1007/s10397-014-0874-0.

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Discharge Less Than 6 Hours After Robotic-Assisted Total Laparoscopic Hysterectomy – Is It Feasible?

Perioperative Outcomes Median (Range) Age (years) 53 (34-73) BMI 25 (19-42) Operating time “skin-to-skin” (minutes) 82 (35-170) Estimated blood loss (ml) 30 (10-100) Conversion to open surgery (cases) 0 Length of hospital stay after the operation (minutes) 225 (150-270) Readmissions 0 Opioid after discharge (patients) 3


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Results • All patients except two could be discharged before the day unit closed due to dizziness and a general feeling of

anxiety. The patients stayed at the hospital for observation until the next morning without further examinations or treatment.

• All patients completed the recommended pain regime, and only three patients needed opioids after discharge. One patient had to continue this treatment for more than 24 hours after the operation.

• Postoperative nausea and vomiting after discharge was reported by six patients, but only four patients needed antiemetic medicine during the first 24 hours after discharge.

• One patient was seen in the out-patient clinic within the first week. An infection over the vaginal vault was diagnosed and treated with antibiotics.

• There were no conversions to laparotomy. • No readmission occurred within the first 30 days after the operation.

Conclusion • This study suggests that robotic surgery is feasible in fast-track programs for TLH. • After RTLH, discharge within 6 hours is feasible. 91% of the patients could be discharged as planned in less than

6 hours after the operation, without any readmissions. • Successful assignment of laparoscopic surgical procedures to day units requires careful selection of patients.

Limitations • Single surgical center • Small sample size • Whether hysterectomy in day units can be generally undertaken in elderly patients remains to be shown.

In this study, two patients older than 70 years of age were discharged within the time limits along with the younger patients.

Discharge Less Than 6 Hours After Robotic-Assisted Total Laparoscopic Hysterectomy – Is It Feasible?


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Overview • Meta-analysis performed to consider whether robot-assisted laparoscopic hysterectomy has any

advantages over traditional laparoscopic hysterectomy • Assessed 5 key indices associated with societal and hospital costs, patient safety and intervention quality

– Included EBL, operative time, number of conversions to laparotomy, LOS and number of postoperative complications

– Patient age, BMI, uterine weight and number of nodes retrieved were also considered for inclusion • There were a total of 1,280 robotic and 1,386 laparoscopic hysterectomies included in the analyses,

covering both malignant and benign conditions

Robot-Assisted Laparoscopic Hysterectomy vs Traditional Laparoscopic Hysterectomy: Five Metaanalyses

Michele Scandola, Lorenzo Grespan, Marco Vicentini, Paolo Fiorini. Robot-assisted laparoscopic hysterectomy vs traditional laparoscopic hysterectomy: five metaanalyses. J Minim Invasive Gynecol. 2011 Nov-Dec; 18(6): 705-715. doi: 10.1016/j.jmig.2011.08.008

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# of Studies Odds Ratio 95% Confidence Interval

p value

Estimated Blood Loss 14 -0.61 (-47.42; 46.20) NS

Operative Time 20 0.66 (-15.72; 17.04) NS

Length of Stay 17 -0.43 (-0.68; -0.17) 0.05*

Conversion to Laparotomy 15 0.49 (0.31; 0.77) 0.05*

Postoperative Complications 14 0.68 (0.49; 0.94) 0.05*

*Favorable to da Vinci


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Conclusion • When compared with traditional laparoscopic hysterectomy, robot-assisted

laparoscopic hysterectomy was associated with shorter LOS, and fewer postoperative complications and fewer conversions to laparotomy

• Evidence indicated that both EBL and operative time were less in the robotic cohort, however the differences were not statistically significant

• Compared with traditional laparoscopic hysterectomy, robotic-assisted hysterectomy might have an overall smaller effect on hospital, societal, and psychophysiologic stress factors

Limitations • Considered hysterectomies performed to treat both benign and malignant diseases

together • Inclusion of cases in which lymphadenectomy was performed, a surgical procedure

that might affect some of the indices such as EBL and operative time



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Overview • Assesses the effect on cost of care and perioperative outcomes of adoption minimally

invasive surgical techniques for hysterectomy at Brigham and Women’s Hospital (Boston, MA)

• Between 2006 and 2009, the primary modality for hysterectomy at the institution shifted from open surgery to minimally invasive surgery

Increasing Minimally Invasive Hysterectomy: Effect on Cost and Complications

Gudrun Maria Jonsdottir, Selena Jorgensen, Sarah L. Cohen, Kelly N. Wright, Neel T. Shah, Niraj Chavan, Jon Ivar Einarsson. Increasing minimally invasive hysterectomy: effect on cost and complications. Obstet Gynecol. 2011 May; 117(5): 1142–1149. doi: 10.1097/AOG.0b013e3182166055

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Abdominal (n=1,070)

Vaginal (n=300)

Laparoscopic (n=678)

dV (n=85)*

Estimated Blood Loss (mL) 363±388 143±189 110±144 75±162

Conversion (%) - 2 (1.5) 22 (4.4) 0 (0) Major Intraoperative Complications** (%) 30 (7.8) 3 (2.3) 8 (1.6) 1 (1.6)

Major Postoperative Complications ***(%) 35 (9.1) 6 (4.5) 17 (3.4) 1 (1.6)

Minor Postoperative Complications# (%) 24 (6.2) 12 (9.0) 24 (4.8) 1 (1.6)

*Majority of robotic cases were oncology cases, often radical hysterectomies **Major intraoperative complications include: Organ injury, estimated blood loss greater than or equal to 1,000 mL or both ***Major postoperative complications include: Readmission, reoperation, ileus, or pulmonary embolia #Minor postoperative complication include: infection (urinary, wound, or chest infection or a low-grade fever), deep vein thrombosis, or other non-specified (majority; urinary retention) The data table provides a summary of outcomes and complications by surgical modality in 2009. However, statistical analysis was not performed across study groups.

Perioperative Outcomes and Complications for 2009


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Total Mean Cost 2006 2009 % Difference P-value

Composite Cost 11,812 ±8,510 12,296 ±6,606 4.1 0.142

Abdominal Hysterectomy 13,347 ±9,855 12,678 ±7,471 -5.0 <0.147

Laparoscopic Hysterectomy 9,288 ±4,050 12,329 ±6,317 32.7 <0.001

Vaginal Hysterectomy 7,693 ±2,378 11,820 ±6,000 53.7 <0.001

Robotic-Assisted Hysterectomy 16,004 ±2,397 11,004 ±4,208 -31.2 <0.001


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Conclusion • Robotic-Assisted surgery was associated with a lower estimated blood loss as well as fewer

conversions, major intraoperative complications, major postoperative complications, and minor postoperative complications

• Robotic-Assisted surgery represented the least expensive modality to perform a hysterectomy in 2009

• From 2006 to 2009, total mean cost increased significantly for vaginal and laparoscopic hysterectomy (p<0.001) but decreased for robotic-assisted hysterectomy (p<0.001)

Limitations • Retrospective study • Inherent selection bias • Data collection subject to measurement bias as a result of inaccurate coding of procedures

or errors in data gathering



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Overview • Examines the outcomes of robotically-assisted laparoscopic hysterectomy in 256 patients

with benign conditions involving high uterine weight (>250 g) and complex pathology • Mutlicenter study including patients from 5 community practices operated on from March

2006 through July 2009 • Reviews outcomes including operative time, conversion to exploratory laparotomy, blood

loss, complications and length of stay

Robotically-Assisted Hysterectomy in Patients with Large Uteri

Thomas N. Payne, Francis R. Dauterive, Michael C. Pitter, Hoang N. Giep, Bang N. Giep, Terry W. Grogg, K. Anthony Shanbour, Darren W. Goff, Helen B. Hubert. Robotically assisted hysterectomy in patients with large uteri: outcomes in five community practices. Obstet Gynecol. 2010 March; 115(3): 535–542. doi: 10.1097/AOG.0b013e3181cf45ad

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Practice 1 (n=80)

Practice 2 (n=79)

Practice 3 (n=55)

Practice 4 (n=25)

Practice 5 (n=17)

Total (N=256) Range

Ave BMI 31.1 30.6 30.5 34.7 29.9 31.1 18-61.6

Mean Uterine Weight (g) 596.1 660.0 484.8 484.7 498.5 574.5 250-3,020

Previous Surgery (%) 56.3 55.7 69.1 48.0 17.7 55.5 NA

Conversion (%) 2.5 0.0 3.6 0.0 0.0 1.62 NA

Complications (%) 1.3 7.6 1.8 4.0 0.0 3.5 NA

LOS (day) 1.1 1.2 1.0 1.0 1.4 1.1 1-11

EBL (ml) 81.4 112.3 91.9 105.0 132.4 98.9 10-800

Mean skin-to-skin operative time (min) 123.7 193.41 148.6 138.7 125.5 151.4 40-340

1 Practice 2’s operative time affected by high percentage of additional procedures, where all patients received a modified McCall’s culdoplasty during surgery. 2 3 of the 4 conversions due to lack of intraabdominal space because of the large size and shape of uteri.


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Conclusion • Despite the longer operative time often required, the results show that robotically assisted

hysterectomy in women with large uteri can be accomplished with few conversions to abdominal hysterectomy, minimal blood loss, short hospital stay, and a low rate of major and minor complications

• Results were reproducible among general gynecologists from geographically diverse community settings

Limitations • Retrospective study • Observational nature of the data • Ascertainment of complications did not include minor conditions after hospital discharge • Underpowered for tests of differences across practices

Financial Disclosure: Dr. Payne has received compensation from Intuitive Surgical® for consulting and/or educational services.



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Overview • Reports the perioperative outcomes after robotically-assisted total hysterectomy for

benign indications with complex pathology in 152 patients who underwent surgery from May 2005 to May 2008

• A systematic chart review of consecutive robotic cases was conducted based on preoperative and perioperative characteristics

• Each case was evaluated for complexity based on preoperative diagnosis, prior pelvic or abdominal surgery, patient’s BMI and uterine weight

Perioperative Outcomes of Robotically Assisted Hysterectomy for Benign Cases with Complex Pathology

Boggess JF, Gehrig PA, Cantrell L, Shafer A, Mendivil A, Rossi E, Hanna R. Perioperative outcomes of robotically assisted hysterectomy for benign cases with complex pathology. Obstet Gynecol. 2009 Sep;114(3):585-93.

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dV (N=152) Subgroup of uterine weight ≥ 500 g (N=29)

Subgroup of BMI ≥ 30 (N=98)

Range for All Patients

Ave Age (yr) 46.9 Not reported NR 23 – 88

Ave BMI 30.7 NR NR 17.0 – 63.3

Ave Uterine Weight (g) 347.0 NR NR 44 – 2,140

Previous Pelvic or Abdominal Surgery (%) 61.8 NR NR NA

Operating Time (min) 122.91 155.82 130.8 43 – 325

EBL (mL) 79.0 135.3 103.3 10 – 1,2003

LOS (day) 1.05 1.0 1.0 0 – 3

Conversions (%) 0 0 0 NA

Intraoperative Complications (%) 2.1%4 1.3% 2.6% NA

Postoperative Complications (%) 3.5%5 1.3% 2.6% NA

1 44.7% of cases were teaching cases, leading to slightly longer operative times (125.5 mins vs 119.5 mins, p=0.4) 2 Increased operative time primarily due to longer morcellation time (ave morcellation time of 41.6 mins) 3 Three patients with over 500 mL EBL had uterine weight above 1,000 g. 4 Intraoperative complications include: left ureteral injury, small bowel enterotomy, and vaginal laceration. 5 Postoperative complications include: recurrent and postoperative UTI, transient femoral nerve palsy, vaginal cuff abscess, and vaginal hematoma


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Conclusion • Most patients had complex pathology and demonstrated a lack of perioperative blood transfusions,

a short hospital stay, low blood loss, low morbidity rates, and short operative times • All cases were successfully completed robotically without the need for conversion • Robotically-assisted total hysterectomy for benign indications in patients with complex pathology is feasible • This study suggests the increased precision and dexterity afforded by the use of robotic assistance allows for

a safe and efficient surgery even for patients with complex pathology

Limitations • No data reported for concurrent lap or abdominal cohorts for comparison • The generalizability of the results may be limited due to the level of experience of the primary surgeon • Residents assisted mainly on the less complex cases

Financial Disclosure Dr. Boggess has received compensation from Intuitive Surgical® for consulting and/or educational services.



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Overview • Compares gynecologic practice and perioperative outcomes of patients

intended to undergo total laparoscopic hysterectomy and robotic-assisted hysterectomy before and after implementation of a robotics program

• Retrospective chart review of 200 consecutive hysterectomy cases for benign indications between November 2004 and January 2007

A Comparison of Total Laparoscopic Hysterectomy to Robotically Assisted Hysterectomy

Payne, T. N. and F. R. Dauterive. A comparison of total laparoscopic hysterectomy to robotically assisted hysterectomy: surgical outcomes in a community practice. J Minim Invasive Gynecol, 2008;15(3):286-291.

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Pre-robotic (n=100)

dV (n=100) Last 25 dV p value

Age (years) 43.5 43.2 -

BMI 28.8 28.8 -

Estimated blood loss (ml) 113 61 <.0001

Hospital stay (days) 1.6 1.1 <.007

TAH rate 20% 4% 0% .0008

Conversions (subset of TAH) 9% 4% 0% .0003

Avg. uterine weight of conversions 359.5 1387.5 .008

TAH due to adhesions 8% 0% Not stated

Operative times (skin-to-skin) 92.4 119 78.7 <.0001


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Conclusions • Compared to the pre-robotic cohort, the robotic cohort experienced the following:

– Reduced operative times once through the learning curve – Reduced blood loss – Reduced length of stay

• Overall laparotomy (TAH) rate was reduced 5x from 20% in the pre-robotic group, down to 4% in the robotic group, then down to 0 in the last 25 robotic procedures

• Conversions (a subset of the TAH rate) decreased from 9% in the pre-robotic group to 4% in the robotic group • Robotics may facilitate the minimally invasive treatment of patients while potentially reducing the rate of

abdominal hysterectomies.

Limitations • Retrospective study • Does not involve a case-matched historical control • Potential selection bias

Financial Disclosure Dr. Payne has received compensation from Intuitive Surgical® for consulting and/or educational services.



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Hysterectomy (Benign): urinary tract injury, vaginal cuff problem (separation, adhesions, granulation tissue, infection, cellulitis, hematoma), bladder injury, bowel injury, vaginal tear or laceration, vaginal shortening, voiding dysfunction, fistula formation: vesicovaginal, rectovaginal. Uterine tissue may contain unsuspected cancer. The cutting or morcellation of uterine tissue during surgery may spread cancer, and decrease the long-term survival of patients.

Surgical Risks

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Important Safety Information

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SC

DA VINCI® SACROCOLPOPEXY

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STUDY MAIN AUTHOR(S) YEAR

Outcomes Of Abdominal And Minimally Invasive Sacrocolpopexy: A Retrospective Cohort Study

Nosti 2014

Cost Analysis Of Open Vs Robotic-assisted Sacrocolpopexy Hoyte 2012

Prospective Comparison Of Short-term Functional Outcomes Obtained After Pure Laparoscopic And Robot-assisted Laparoscopic Sacrocolpopexy

Seror 2012

Robotic Vs Abdominal Sacrocolpopexy: 44-month Pelvic Floor Outcomes Geller 2012

INDEX – Sacrocolpopexy

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Overview • Multi-center retrospective study comparing perioperative and postoperative surgical

outcomes between and among open and minimally invasive sacrocolpopexies (MISC) • 1,124 patients underwent sacrocolpopexy between January 1999 to December 2010,

with 589 abdominal sacrocolpopexies and 535 minimally invasive sacrocolpopexies (273 laparoscopic and 262 robotic)

Outcomes of Abdominal and Minimally Invasive Sacrocolpopexy: A Retrospective Cohort Study

Patrick A. Nosti, Uduak Umoh Andy, Sarah Kane, Dena E. White, Heidi S. Harvie, Lior Lowenstein, Robert E. Gutman. Outcomes of abdominal and minimally invasive sacrocolpopexy: a retrospective cohort study. Female Pelvic Med Reconstr Surg. 2014 Jan-Feb; 20(1): 33-37. doi: 10.1097/SPV.0000000000000036

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Intraoperative & Postoperative Complications

ASC (n=589)

MISC (n=535) P-Value LSC

(n=273) RSC

(n=262) P-Value

All Complications 20% 12.7% <0.01 18% 7% <0.01

Cystotomy 4% 2% <0.01 2.5% 1.5% 0.7

DVT/PE 1.5% 1% 0.3 3% 0.0% <0.01

Ileus/SBO 5% 2% <0.01 1.8% 1.5% 1

Conversion to Open - - - 4% 0.4% <0.01

Anatomical Failure ASC MISC P-Value LSC RSC P-Value

At or beyond hymen 15.1% 7.4% <0.001 6.5% 8.4% 0.49

Stage 2 or higher 25.3% 14.2% <0.001 11.3% 17.2% 0.069

ASC=abdominal sacrocolpopexy, MISC=minimally invasive sacrocolpopexy, LSC=laparoscopic sacrocolpopexy, RSC= robotic sacrocolpopexy


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Conclusion • Abdominal sacrocolpopexy was associated with greater overall complication rate

compared with MISC • The MISC group had shorter hospitalization, less blood loss, but longer operative times

compared with ASC group • LSC was associated with more complications compared with RSC

― Patients who underwent LSC were more likely to have their procedure converted to open and more likely to develop a DVT/PE

― LSC was associated with shorter operative time and shorter length of hospitalization than RSC

Limitations • Retrospective study • Study investigators used a composite complication score which may not account for all

adverse events • Definition of failure did not include subjective data which were inconsistently available



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Overview • Retrospective study compares consecutive open (n=91) and robotic-

assisted sacrocolpopexies (n=73) performed beyond the learning curve • Hospital direct costs, operative times and length of stay were compared

for the two groups including robot cost and maintenance amortized over a 7 year useful life

Cost Analysis of Open vs Robotic-Assisted Sacrocolpopexy

Lennox Hoyte, Roshanak Rabbanifard, Jennifer Mezzich, Renee Bassaly, Katheryne Downes. Cost analysis of open versus robotic-assisted sacrocolpopexy. Female Pelvic Med Reconstr Surg. 2012 Nov-Dec; 18(6): 335–339. doi: 10.1097/SPV.0b013e318270ade3

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dV Sacrocolpopexy

Abdominal Sacrocolpopexy p Value

Operative Time 3:32 (1:59-6:20)

2:46 (1:39-6:34) <0.001

Length of Stay 2 (1-5)

3 (1-25) <0.001

Direct Costs (no robot)

$6,039 ($3,653-$8,958)

$7,804 ($3,828-$16,878)

<0.001

Direct Costs (robot)* $6,667 ($4,280-$9,585) 0.002

*Capital and maintenance costs amortized over 7 years @ 500 procedures per year


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dV Sacrocolpopexy Abdominal Sacrocolpopexy p Value

Operating Room 2050 1320 <0.001

Surgical Supply (including mesh) 1859 3013 0.002

Supply Distribution 367 336 0.248

Pharmacy 238 484 <0.001

Postoperative Pharmacy 46 140 <0.001

Anesthesia 197 187 <0.001

Laboratory 179 165 0.256

Postoperative Laboratory 12 23 <0.001

Radiology 29 52 0.013

Bed Cost 767 1209 <0.001

Postoperative Bed Cost 0 806 <0.001

Breakdown of Direct Hospital Cost Components (in US Dollars) for Open and Robotic-Assisted Sacrocolpopexy


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Conclusion • Median operative time for robotic-assisted sacrocolpopexy was longer than open,

but mean length of stay was shorter and EBL was lower • Even with inclusion of the robotic capital and maintenance costs, total costs per

procedure were significantly less for robotic-assisted than open sacrocolpopexy ($6668 vs. $7804 [P = 0.002])

• 34-minute reduction in robotic operative time was achieved by moving to continuous barbed suture for attaching the mesh leaflets to the vagina

Limitations • Retrospective study • Lack of long-term clinical follow-up • Reflects the experience of a single surgeon at one site and the results may not be

generalizable to other institutions



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Overview • Prospectively compares short-term functional outcomes of women who

underwent either robot-assisted laparoscopic sacrocolpopexy (RALSCP) or laparoscopic sacrocolpopexy (LSCP) for pelvic organ prolapse over a 24 month time period

• Clinical, perioperative and post-operative data were collected

Prospective Comparison of Short-Term Functional Outcomes Obtained After Pure Laparoscopic and Robot-Assisted Laparoscopic Sacrocolpopexy

Julien Seror, David R. Yates, Elise Seringe, Christophe Vaessen, Marc-Olivier Bitker, Emmanuel Chartier-Kastler, Morgan Rouprêt. Prospective comparison of short-term functional outcomes obtained after pure laparoscopic and robot-assisted laparoscopic sacrocolpopexy. World J Urol. 2012 June; 30(3): 393–398. Published online 2011 August 20. doi: 10.1007/s00345-011-0748-2

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dV

Sacrocolpopexy (n=20)

Laparoscopic Sacrocolpopexy

(n=47) p Value

Operative Blood Loss (mL) 55 280 0.03

Strict Operative Time* (min) 128 231 <0.0001

Overall Operative Room Time (min) 217 231 0.4

Duration of Catheter (days) 2.5 3.1 0.03

Overall Anatomic Repair Rate (%)** 98.5 NS

*This study defines strict operative time as time for port insertion plus procedure and excludes the preparation and docking of the robot.

**With a median follow-up of 16 months, the overall anatomic repair rate was 98.5%, and there was an improvement in overall PFDI-20 score before and after surgery (P = 0.001) but with no difference between the two surgical approaches.


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Conclusion • Robot-assisted laparoscopic sacrocolpopexy allows for a safe and effective

repair of pelvic organ prolapse in female patients • Robotic sacrocolpopexy is comparable to laparoscopic in terms of functional

outcome, but is superior in our hands in terms of blood loss and strict operative time

• Postoperative results were comparable for pain, hospital stay, functional outcome and overall complication rate

Limitations • Patients not randomized • Results may be due to surgeon experience and may not be transferable



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Overview • Evaluates long-term clinical outcomes after robotic and abdominal

sacrocolpopexy for the treatment of advanced pelvic organ prolapse • The analysis included 51 subjects (23 robotic, 28 abdominal) who underwent

sacrocolpopexy between March 2006 and October 2007 • With validated questionnaires, measures pelvic floor support (POP-Q),

pelvic floor function (PFDI-20, PFIQ-7), urinary incontinence and sexual function (PISQ-12)

Robotic vs Abdominal Sacrocolpopexy: 44-Month Pelvic Floor Outcomes

Elizabeth J. Geller, Brent A. Parnell, Gena C. Dunivan. Robotic vs abdominal sacrocolpopexy: 44-month pelvic floor outcomes. Urology. 2012 March; 79(3): 532–536. doi: 10.1016/j.urology.2011.11.025

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*For PFDI-20 and PFIQ-7, a higher score indicates more pelvic floor dysfunction or bothersome symptoms, with 300 being the highest possible score. **For PISQ-12, a higher score indicates a better level of sexual function, with 48 being the highest possible score. †This range data point was accidentally omitted from the published journal article.

Pelvic floor function based on quality-of-life questionnaires at 44 months postoperative:

Robotic Sacrocolpopexy (N = 23)

Abdominal Sacrocolpopexy

(N = 28) p Value

Pre-op POP-Q C Point +2 (-1 to +5) -1.5 († to +5) 0.08

Post-op POP-Q C Point -8 (-7 to -9) -7 (-7 to -8) 0.22

Estimated Blood Loss (mL) 151 + 111 219 + 157 0.09

Cure Rate POP-Q C Point 100% 100% -

PFDI-20 61.0 + 55.3 54.9 + 49.2 0.92

PFIQ-7 19.1 + 40.4 15.3 + 24.1 0.38

PISQ-12 35.1 + 7.2 33.6 + 0.3 0.55


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Conclusion • Robotic sacrocolpopexy demonstrated similar short-term vaginal vault support compared

with abdominal sacrocolpopexy, with longer operative time, less blood loss, and shorter length of stay.

• There were more concurrent hysterectomies and anti-incontinence procedures in the robotic group; there were more posterior colporrhaphies in the abdominal group

• Both anatomic support and pelvic floor function for robotic sacrocolpopexy is maintained at 44 months after surgery when compared with both preoperative data and long-term outcomes for abdominal sacrocolpopexy

Limitations • Retrospective study • Single institution study • The POP-Q was administered by investigators



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Sacrocolpopexy: mesh erosion/infection (if mesh used in repair) with need for re-operation, rectal injury, bladder injury, rectocele, cystocele, urinary tract injury, vaginal cuff dehiscence, urinary incontinence, hematoma (retropubic, perineal or other).

Surgical Risks

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DA VINCI® MYOMECTOMY

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INDEX – Myomectomy


Robotic-assisted Laparoscopic Vs Abdominal And Laparoscopic Myomectomy: Systematic Review And Meta-analysis

Pundir 2013

Robotic-assisted, Laparoscopic And Abdominal Myomectomy: A Comparison Of Surgical Outcomes

Barakat 2011

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Overview • Systematic review and meta-analysis of evidence related to operative outcomes

associated with robotic-assisted laparoscopic myomectomy (RLM) compared with abdominal myomectomy (AM) and laparoscopic myomectomy (LM)

― vs. open: 7 studies, n=1,127 (RLM: 435, AM: 692)

― vs. lap: 4 studies, n=602 (RLM: 318, LM: 284)

• Outcome measures included estimated blood loss (EBL), blood transfusion, operating time, complications, length of hospital stay (LOHS), and costs

Robotic-Assisted Laparoscopic vs Abdominal and Laparoscopic Myomectomy: Systematic Review and Meta-Analysis

Jyotsna Pundir, MRCOG, Vishal Pundir, MRCS, Rajalaxmi Walavalkar, MRCOG, Kireki Omanwa, MRCOG, Gillian Lancaster, PhD, and Salma Kayani, MRCOG. “Robotic-Assisted Laparoscopic vs. Abdominal and Laparoscopic Myomectomy: Systematic Review and Meta-Analysis.” JMIG, 2013; 20(3): 335-345

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Surgical Approach RLM vs. AM RLM vs. LM

EBL + (p<.001) (p=.34)

Hemoglobin Drop + (p<.001) Not reported

Blood Transfusion + (p<.02) − (p=.04)

Operative Time − (p<.001) (p=.26)

Major Complications (p<.90) (p=.57)

Minor Complications (p<.68) Not reported

Fever + (p<.001) Not reported

LOS + (p<.001) (p=1.00)

Cost − (p<.001) − (not analyzed)*

+ favorable for RLM, – unfavorable for RLM, comparable with RLM *$56K vs. $34.5K (Reported in only one study, statistical analysis was not performed)



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Conclusion • Robotic-Assisted myomectomy is associated with short-term benefits compared with open surgery and

shows comparable outcomes to laparoscopic surgery • Myomectomy is still primarily performed abdominally due to the limitations of conventional laparoscopic

surgery • Although operating time and cost associated with RLM was significantly higher, the LOHS was significantly

shorter with RLM • Robotic-Assisted myomectomy is evolving and promises to have a role in a specific group of patients to

avert laparotomy by enabling minimal access surgery

Limitations • All studies were retrospective and observational in nature • Comparison limited to small number of papers • Small number of myomectomies studied • Surgeons conducting study are experts so results may not be transferrable to the general surgeon population



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Overview • The objective of the study was to compare operative and immediate

postoperative surgical outcomes of robot-assisted laparoscopic myomectomy (robot-assisted), standard laparoscopic myomectomy (laparoscopic), and open myomectomy (abdominal)

• 575 patients who underwent myomectomy between January 1995 and December 2009 - 89 robot-assisted, 93 laparoscopic, and 393 open

Robotic-Assisted, Laparoscopic and Abdominal Myomectomy: A Comparison of Surgical Outcomes

Ehab E. Barakat, Mohamed A. Bedaiwy, Stephen Zimberg, Benjamin Nutter, Mohsen Nosseir, Tommaso Falcone. Robotic-assisted, laparoscopic, and abdominal myomectomy: a comparison of surgical outcomes. Obstet Gynecol. 2011 February; 117(2 Pt 1): 256–265. doi: 10.1097/AOG.0b013e318207854f

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1 Abdominal compared with laparoscopic, P=.142; abdominal compared with robotic, P=.003; laparoscopic compared with robotic, P=.083. 2 Abdominal compared with laparoscopic, P<.001; abdominal compared with robotic, P=.360; laparoscopic compared with robotic, P=.021. 3 Abdominal compared with laparoscopic, P<.001; abdominal compared with robotic, P<.001; laparoscopic compared with robotic, P=.818. 4 Abdominal compared with laparoscopic, P=.061; abdominal compared with robotic, P<.001; laparoscopic compared with robotic, P=.431. 5 Abdominal compared with laparoscopic, P<.001; abdominal compared with robotic, P<.001; laparoscopic compared with robotic, P=.506.

Abdominal Laparoscopy dV Overall P

Surgical Time (min) 126.00 155.00 181.00 <.0011

Myoma Weight (g) 263.00 96.65 223.00 <.0012

Estimated Blood Loss (mL) 200.00 150.00 100.00 <.0013

Hemoglobin Drop (g/dL) 2.00 1.55 1.30 <.0014

Length of Stay (days) 3.00 1.00 1.00 <.0015



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Conclusion • Robotic-assisted myomectomy is associated with decreased blood loss and length of

hospital stay as well as less drop in postoperative hemoglobin compared with traditional laparoscopy and to open myomectomy

• The weight and number of the removed myomas was comparable between both robotic and open groups while being significantly lower in the laparoscopic group

• Study suggests that robotic technology allowed cases that typically would have been done open to be done minimally-invasively.

Limitations • Retrospective • Lack of long-term outcomes



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Surgical Risks

Myomectomy: uterine perforation, uterine rupture, preterm birth, spontaneous abortion Uterine tissue may contain unsuspected cancer. The cutting or morcellation of uterine or fibroid tissue during surgery may spread cancer, and decrease the long-term survival of patients. M

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DA VINCI® ENDOMETRIOSIS RESECTION

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INDEX – Endometriosis Resection


Robotic-assisted Laparoscopy For Deep Infiltrating Endometriosis: International Multicentric Retrospective Study

Collinet 2014

Restrospective Analysis Of Robotic-assisted Vs Standard Laparoscopy In The Treatment Of Pelvic Pain Indicative Of Endometriosis

Dulemba 2013

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Overview • Designed to assess the interest of RAL for DIE and to investigate the perioperative results: evaluation of the

procedure performed, the duration of the intervention, the complications, the recurrence and the impact on fertility.

• Study includes 164 women with stage 4 endometriosis who underwent robotic-assisted laparoscopy (RAL) from Nov. 2008 to April 2012 in 8 international centers.

• Conducted in collaboration with the French Society CRG (Chirugie Robotique Gynécologique) and SERGS (Society of European Robotic Gynecological Surgery).

Robotic-Assisted Laparoscopy for Deep Infiltrating Endometriosis: International Multicentric Retrospective Study

Collinet P, Leguevaque P, Neme RM, Cela V, Barton-Smith P, Hébert T, Hanssens S, Nishi H, Nisolle M. "Robot-assisted laparoscopy for deep infiltrating endometriosis: international multicentric retrospective study." Surgical Endoscopy 28.8 (2014):2474-2479. Epub.

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Complications Rectum 88

Bladder 23

Ureter + Uterosacral Ligaments

115

Hysterectomy 28

Total 164

Trocars 3.12 3.78 3.16 2.92 3.24

Operative time (min) 188.2 ±75.7 207.2 ± 85.5 183.9 ± 83.6 198.5 ± 94.9 180 ± 77.2

Blood loss (ml) 127.5 ± 293.3 57.6 ± 251.8 118.6 ± 289 88.2 ± 139.7 85.1 ± 241.3

Main complications 1 conversion to

laparotomy 1 Blood transfusion

1 vesicovaginal hematoma

1 case of prolonged self-catherization

2 ureteral fistulas 1 wound dehiscence

after uterovesical reimplantation

None

Hospital stay 4.2 ± 2.7 5.1 ± 2.5 3.7 ± 3.0 4.0 ± 3.1 4.0 ± 2.8

Follow-up (months) 11.4 ± 8.6 9.7 ± 7.5 9.8 ± 8.2 12.7 ± 8.2 10.2 ± 8.5

Recurrence: n (%) 9/88 (10.2) 2/23 (8.7) 11/115 (9.6) 2/115 (7.1) 12/102 (11.8)

Delay (months) 0.5 ± 4.9 19.5 ± 1.5 5.8 ± 5.2 7.7 ± 1.2 6.9 ± 9.3

Subsequent fertility: n (%) 8/88 (10.2) 0 8/75 (10.7) 0 13/97 (13.4)



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Conclusion • According to the author, DIE is one of the best indications for RAL in gynecologic surgery • RAL appears to reduce the rates of conversion to laparotomy and of laparotomy itself • Low morbidity for complex and multiple procedures (1.8% of re- intervention) • Comparative studies for each procedure comparing SL and RAL are needed

Limitations • Retrospective study • No comparative data • Lack of long term follow up • No pre and post operation evaluation of quality of life


PN1009859 Rev A

, 06/14


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Overview • Retrospective study examines the feasibility of treating pelvic pain in patients with suspected

endometriosis using robot-assisted laparoscopic techniques

• Operative characteristics were analyzed for last 100 standard laparoscopic (December 2004–September 2007) and the first 180 robot-assisted (July 2007–January 2010) surgeries to treat suspected endometriosis.

• Perioperative outcomes and postoperative pain were compared by technique including operative time, blood loss and complication rates

Restrospective Analysis of Robotic-Assisted vs Standard Laparoscopy in the Treatment of Pelvic Pain Indicative of Endometriosis

Dulemba, John F., Cyndi Pelzel, and Helen B. Hubert. "Retrospective Analysis of Robot-assisted versus Standard Laparoscopy in the Treatment of Pelvic Pain Indicative of Endometriosis." Journal of Robotic Surgery 7.2 (2013): 163-69. Print.

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Robot-assisted Laparoscopy p Value

Operative time (minutes) 77.4 72.3 0.23

Patients w/ confirmed endometriosis 80.0% 56.8% <0.001

Appendectomy 23.3% 30.0% 0.32

Appendix positive for endometriosis 28.6% 3.3% 0.02



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Conclusion • Demonstrates that robot-assisted laparoscopic surgery for the treatment of pelvic pain indicative of

endometriosis is feasible across all disease stages, with low morbidity and operative time comparable to laparoscopy

• Rates of suspected endometriosis on visual examination were similar in robot-assisted and conventional laparoscopic surgeries, but histological confirmation was significantly higher for the robotic cohort (80.0 vs. 56.8 %, p<0.001)

• Study suggests robot-assisted techniques, compared to standard laparoscopy, may provide more accurate visualization and, thus, excision of existing endometriosis

Limitations • Retrospective • Single surgeon experience • Lack of validated and longer-term outcome measures

Financial Disclosure: Dr. Dulemba has received compensation from Intuitive Surgical® for consulting and/or educational services.


Dulemba, John F., Cyndi Pelzel, and Helen B. Hubert. "Retrospective Analysis of Robot-assisted versus Standard Laparoscopy in the Treatment of Pelvic Pain Indicative of Endometriosis." Journal of Robotic Surgery 7.2 (2013): 163-69. Print.

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Endometriosis resection: bowel injury, bladder injury, urinary tract injury

Surgical Risks

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Important Safety Information HC

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OTHER PUBLICATIONS

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INDEX – Other STUDY MAIN AUTHOR(S) YEAR SUBJECT

A Comparison Of Outcomes Between Robotic-assisted Single-Site Laparoscopy Vs Laparoendoscopic Single Site (LESS) For Benign Hysterectomy

Lopez 2015 Other: Single-site

Robotic Surgery Training In Gynecologic Fellowship Programs In The United States

Fatehchehr 2014 Other: Training

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Overview • The objective was to compare perioperative outcomes including estimated blood loss,

conversion to open laparotomy, length of stay and total operative time of hysterectomies using robotic-assisted Single-Site laparoscopy with Laparoendoscopic Single Site (LESS) for benign indications

• Retrospective analysis comparing (50 consecutive robotic-assisted Single-Site vs. 50 consecutive LESS) patients undergoing a hysterectomy for benign indications

• Multi-Center study conducted in private hospital setting

A Comparison of Outcomes Between Robotic-Assisted Single-Site® Laparoscopy vs Laparoendoscopic Single Site (LESS) for Benign Hysterectomy

Lopez S, Mulla ZD, Hernandez L, Garza DM, Payne TN, Farnam RW, A Comparison of Outcomes between Robotic-Assisted Single-Site Laparoscopy versus Laparoendoscopic Single Site (LESS) for Benign Hysterectomy, The Journal of Minimally Invasive Gynecology (2015), doi: 10.1016/j.jmig.2015.08.883.

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Learning Curve Analysis

Tota

l Ope

rativ

e Tim

e

Procedure Number

Robotic-assisted Single-Site

Linear (Robotic-assisted Single-Site)

Linear (LESS) LESS

0 5 10 15 20 25 30 35 40 45 50 0

20

40 60 80

100 120 140 160 180 200 220 240 260

Lopez S, Mulla ZD, Hernandez L, Garza DM, Payne TN, Farnam RW, A Comparison of Outcomes between Robotic-Assisted Single-Site® Laparoscopy versus Laparoendoscopic Single Site (LESS) for Benign Hysterectomy, The Journal of Minimally Invasive Gynecology (2015), doi: 10.1016/j.jmig.2015.08.883.

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Conclusion • Robotic-assisted Single-Site group had a statistically-significant decrease in length of hospital

stay (8.12 hrs. shorter) but experienced an increase in total operative time (24.9 min. longer). There were no wristed instruments used in this study.

• The learning curve analyzed showed a decrease in total operative time as more cases were performed for each group, however the robotic-assisted Single-Site learning slope was steeper indicating that the robotic-assisted group moved along their learning curve quicker. (P<0.0001)

• There were no conversions to open laparotomies and no relation was detected between what type of approach and the outcome of a major complication.

Limitations • Retrospective cohort study

• Did not control for surgeon experience in regression models

Lopez S, Mulla ZD, Hernandez L, Garza DM, Payne TN, Farnam RW, A Comparison of Outcomes between Robotic-Assisted Single-Site® Laparoscopy versus Laparoendoscopic Single Site (LESS) for Benign Hysterectomy, The Journal of Minimally Invasive Gynecology (2015), doi: 10.1016/j.jmig.2015.08.883.

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Overview • Web-based survey of the 4 ACOG-boarded sub-specialty gynecology fellowship

programs in the United States from November 2010 to March 2011: Minimally Invasive Surgery (MIS), Gynecologic Oncology (Gyn Onc), Female Pelvic Medicine and Reconstructive Surgery (FPMRS), Reproductive Endocrinology and Infertility (REI).

• Survey had 102 respondents (18% response rate) with an almost equal response rate from all four fellowship types.

• Study aimed to clarify the current status of robotic training in gynecologic fellowship programs in the United States.

Robotic Surgery Training in Gynecologic Fellowship Programs in the United States

Fatehchehr S, Rostaminia G, Gardner MO, Ramunno E, Doyle NM. Robotic Surgery Training in Gynecologic Fellowship Programs in the United States.JSLS : Journal of the Society of Laparoendoscopic Surgeons 2014;18(3):e2014.00402. doi:10.4293/JSLS.2014.00402.\

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FPMRS Gyn Onc MIS REI

Robotic curriculum 58% 83% 95% 29%

Didactic >25 hours 27% 30% 33% 6%

>50% hands-on 48% 73% 75% 33%

Simulator training 74% 67% 57% 22%

Graduating with > 50 robotic cases 36% 87% 48% 0%

FPMRS - Female Pelvic Medicine & Reconstructive Surgery; Gyn Onc - Gynecologic Oncology; MIS – Minimally Invasive Surgery; REI - Reproductive Endocrinology & Infertility.



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Conclusion • MIS and Gyn Onc fellowships had the highest rate of robotic training in their fellowship

curriculum – 95% and 83%, respectively • Simulator training was used as a training tool most by the FPMRS fellowship programs (74%)

and least by REI fellowships (22%) • 87% of Gyn Onc fellows graduated with >50 robotic cases, 0% of REI fellows graduated with

>50 robotic cases • 25% of programs dedicated >25 hours per year to robotic training, 19% of programs

dedicated 0 hours • This study showed that the use of a robotic system was built into the fellowship curriculum of

>80% of MIS and Gyn Onc fellowship programs in the study population

Limitations • An Internet survey may create bias towards those who use e-mail and/or who may be more

likely to embrace technological advances such as robotic surgery • The actual number of robotic cases performed is not easily verified and may be under- or

overestimated by responders



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Serious complications may occur in any surgery, including da Vinci® Surgery, up to and including death. Examples of serious or life-threatening complications, which may require prolonged and/or unexpected hospitalization and/or reoperation, include but are not limited to one or more of the following: injury to tissues/organs, bleeding, infection and internal scarring that can cause long-lasting dysfunction/pain. Individual surgical results may vary. Risks specific to minimally invasive surgery, including da Vinci® Surgery, include but are not limited to, one or more of the following: temporary pain/nerve injury associated with positioning; a longer operative time, the need to convert to an open approach, or the need for additional or larger incision sites. Converting the procedure could result in a longer operative time, a longer time under anesthesia, and could lead to increased complications. Contraindications applicable to the use of conventional endoscopic instruments also apply to the use of all da Vinci instruments. You should discuss your surgical experience and review these and all risks with your patients, including the potential for human error and equipment failure. Physicians should review all available information. Clinical studies are available through the National Library of Medicine at www.ncbi.nlm.nih.gov/pubmed. Be sure to read and understand all information in the applicable user manuals, including full cautions and warnings, before using da Vinci products. Failure to properly follow all instructions may lead to injury and result in improper functioning of the device. Training provided by Intuitive Surgical is limited to the use of its products and does not replace the necessary medical training and experience required to perform surgery. Procedure descriptions are developed with, reviewed and approved by independent surgeons. Other surgical techniques may be documented in publications available at the National Library of Medicine. For Important Safety Information, indications for use, risks, full cautions and warnings, please also refer to www.davincisurgery.com/safety and www.intuitivesurgical.com/safety. Unless otherwise noted, products featured are available for commercial distribution in the U.S. For availability outside the U.S., please check with your local representative or distributor. © 2017 Intuitive Surgical, Inc. All rights reserved. Product names are trademarks or registered trademarks of their respective holders. PN 1021164 Rev B 01/17


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