New Surgical New Surgical Advances in Advances in the Treatment the Treatment of Fecal of Fecal Incontinence Incontinence Steven D Wexner, M.D., FACS, FRCS, FRCS Steven D Wexner, M.D., FACS, FRCS, FRCS (Ed) (Ed) Chairman, Department of Colorectal Surgery Chairman, Department of Colorectal Surgery Cleveland Clinic Florida Cleveland Clinic Florida 21st Century Chair in Colorectal Surgery 21st Century Chair in Colorectal Surgery Professor of Surgery, Ohio State University Professor of Surgery, Ohio State University Health Sciences Center at the Health Sciences Center at the Cleveland Clinic Foundation Cleveland Clinic Foundation Clinical Professor of Surgery, Clinical Professor of Surgery, University of South Florida College of Medicine University of South Florida College of Medicine Dept of Biomedical Science Florida Atlantic University College of Medicine Dept of Biomedical Science Florida Atlantic University College of Medicine
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New Surgical New Surgical Advances in the Advances in the
Treatment of Fecal Treatment of Fecal IncontinenceIncontinence
Steven D Wexner, M.D., FACS, FRCS, FRCS (Ed)Steven D Wexner, M.D., FACS, FRCS, FRCS (Ed)Chairman, Department of Colorectal SurgeryChairman, Department of Colorectal Surgery
Cleveland Clinic FloridaCleveland Clinic Florida21st Century Chair in Colorectal Surgery21st Century Chair in Colorectal Surgery
Professor of Surgery, Ohio State UniversityProfessor of Surgery, Ohio State UniversityHealth Sciences Center at theHealth Sciences Center at theCleveland Clinic FoundationCleveland Clinic FoundationClinical Professor of Surgery,Clinical Professor of Surgery,
University of South Florida College of MedicineUniversity of South Florida College of MedicineDept of Biomedical Science Florida Atlantic University College of MedicineDept of Biomedical Science Florida Atlantic University College of Medicine
OVERLAPPING SPHINCTER OVERLAPPING SPHINCTER REPAIR: LONG TERMREPAIR: LONG TERM
49 patients49 patients 6 year follow–up after sphincteroplasty6 year follow–up after sphincteroplasty Telephone interviews using Fecal Telephone interviews using Fecal
Incontinence Quality of Life Scale and Incontinence Quality of Life Scale and Fecal Incontinence Severity IndexFecal Incontinence Severity Index– 46% continence 46% continence – 14% complete continence14% complete continence
Halverson, DCR 2002
OVERLAPPING SPHINCTER OVERLAPPING SPHINCTER REPAIR: LONG TERMREPAIR: LONG TERM
191 patients191 patients 10 year follow-up with questionnaire to assess current 10 year follow-up with questionnaire to assess current
bowel function and quality of lifebowel function and quality of life
Continence ratesContinence rates– 40% at 10 years40% at 10 years– 6% complete continence at 10 years6% complete continence at 10 years
Predictors of incontinence at 10 yearsPredictors of incontinence at 10 years– Older patientsOlder patients– Those with incontinence in short termThose with incontinence in short term
Gutierrez, DCR, 2004
OVERLAPPING SPHINCTER OVERLAPPING SPHINCTER REPAIR: SHORT & LONG TERMREPAIR: SHORT & LONG TERM
65 patients65 patients
CCF/FI score and Browning-Parks scale CCF/FI score and Browning-Parks scale calculated preop, 3 month and 80 month postopcalculated preop, 3 month and 80 month postop
Barisic, Int J Colorectal Dis, 2006
OVERLAPPING SPHINCTER OVERLAPPING SPHINCTER REPAIR: SHORT & LONG TERMREPAIR: SHORT & LONG TERM
CCF/FI score:CCF/FI score: - Improved from 17.8 preop to 3.6 three month postop- Improved from 17.8 preop to 3.6 three month postop - Deteriorated to 6.3 after 80 months (- Deteriorated to 6.3 after 80 months (p<0.001p<0.001))
Pudendal NeuropathyPudendal Neuropathy
AuthorAuthor NN Success Success SuccessSuccess p Valuep Valuewithoutwithout with with
Why do we preserve the scar?Why do we preserve the scar?
Female patients with fecal incontinence who underwent Female patients with fecal incontinence who underwent overlapping anterior sphincter repair between June overlapping anterior sphincter repair between June 1998 and May 1999 were preoperatively evaluated 1998 and May 1999 were preoperatively evaluated with:with:
Anal manometryAnal manometry Electromyography and pudendal nerve terminal motor Electromyography and pudendal nerve terminal motor
Why do we preserve the scar?Why do we preserve the scar? Continence was assessed by standardized scoring Continence was assessed by standardized scoring
from 0 to 20 both before and after surgeryfrom 0 to 20 both before and after surgery The intraoperative ultrasound was performed at The intraoperative ultrasound was performed at
the end of the operation with a 120the end of the operation with a 120 0 0 intrarectal intrarectal transducertransducer
Overlapping SphincteroplastyOverlapping SphincteroplastyWhy do we preserve the scar?Why do we preserve the scar?
Incontinence score pre and post operative in muscle-muscle Incontinence score pre and post operative in muscle-muscle or muscle-scar (type 1-2 overlapping)or muscle-scar (type 1-2 overlapping)
Overlapping SphincteroplastyOverlapping SphincteroplastyWhy do we preserve the scar?Why do we preserve the scar?
1991-19971991-1997 21 patients (67 (40-80) years of age)21 patients (67 (40-80) years of age) 6.8 (0.5-22) years incontinence6.8 (0.5-22) years incontinence 10 prior sphincteroplasties10 prior sphincteroplasties 5% morbidity, 0% mortality at 22.35% morbidity, 0% mortality at 22.3++19 19
Operative procedureOperative procedure– Fat harvesting (50ml), 3-5cm below umbilicusFat harvesting (50ml), 3-5cm below umbilicus– Fat “washing” with salineFat “washing” with saline– Injection submucosally into the rectal neck at the 3 o’clock and Injection submucosally into the rectal neck at the 3 o’clock and
9 o’clock position9 o’clock position
(Shafik, DCR 1997)(Shafik, DCR 1997)
INJECTION OF INJECTION OF AUTOLOGOUS FATAUTOLOGOUS FAT
Follow upFollow up– 9-24 months9-24 months
ResultsResults– 3 patients continent3 patients continent– 9 patients continent after a second injection (6 months 9 patients continent after a second injection (6 months
later)later)– 2 patients partially continent after multiple injections2 patients partially continent after multiple injections
(Shafik, DCR 1997)(Shafik, DCR 1997)
INJECTION OF INJECTION OF AUTOLOGOUS FATAUTOLOGOUS FAT
34 year old female34 year old female Failure of previous anterior sphincteroplastyFailure of previous anterior sphincteroplasty Operative techniqueOperative technique
– Liposuction from the buttockLiposuction from the buttock– Fat injection (70ml) beneath anal mucosa in Fat injection (70ml) beneath anal mucosa in
correspondence with sphincter defectcorrespondence with sphincter defect ResultsResults
– No postoperative complicationsNo postoperative complications– Reinjection of 60ml of fat 4 months laterReinjection of 60ml of fat 4 months later– Fully continent 8 months after 2nd injectionFully continent 8 months after 2nd injection
(Bernardi, Plastic and Reconstruct Surg 1998) (Bernardi, Plastic and Reconstruct Surg 1998)
INJECTABLE SILICONEINJECTABLE SILICONESHORT AND MEDIUM TERM RESULTSSHORT AND MEDIUM TERM RESULTS
Internal anal sphincter augmentation using Internal anal sphincter augmentation using injectable siliconeinjectable silicone
10 patients (6 females)10 patients (6 females) 64 (41-80) years old64 (41-80) years old Weak (6) or disrupted (4) internal sphincterWeak (6) or disrupted (4) internal sphincter Injection – single site (4) or circumferential (6)Injection – single site (4) or circumferential (6)
– 1 improved after 21 improved after 2ndnd injection injection
– 70% success70% success
6 months6 months– Improved: 2Improved: 2
– Minor improvement: 1Minor improvement: 1
– 30% success30% success
INJECTABLE SILICONEINJECTABLE SILICONESHORT AND MEDIUM TERM RESULTSSHORT AND MEDIUM TERM RESULTS
Malouf et al. DCR 2001
INJECTABLE SILICONEINJECTABLE SILICONEMEDIUM TERM RESULTSMEDIUM TERM RESULTS
82 patients82 patients Internal anal sphincter dysfunctionInternal anal sphincter dysfunction 2 groups: Injection of the Bioplastique in the 2 groups: Injection of the Bioplastique in the
intersphincteric spaceintersphincteric space– With guidance of ultrasound (n = 42)With guidance of ultrasound (n = 42)– Without guidance of ultrasound (n= 40)Without guidance of ultrasound (n= 40)
No complicationsNo complications At 1 month, ultrasound confirmed retention of the At 1 month, ultrasound confirmed retention of the
silicone in all patientssilicone in all patients
Tjandra, DCR 2004
Significant improvement:Significant improvement:– In all, at one monthIn all, at one month– In all, at 6 monthsIn all, at 6 months– In group A only, at 12 months (p<0.001)In group A only, at 12 months (p<0.001)
At 6 months, all domains of FI QOL scale At 6 months, all domains of FI QOL scale improved significantly in both groupsimproved significantly in both groups
Prolonged pudendal nerve terminal motor latency Prolonged pudendal nerve terminal motor latency had no effect on outcome in either group.had no effect on outcome in either group.
INJECTABLE SILICONEINJECTABLE SILICONEMEDIUM TERM RESULTSMEDIUM TERM RESULTS
Tjandra, DCR 2004
ACYSTACYSTTMTM or DURASPHERE FI™ or DURASPHERE FI™
1cc Syringe
Carbon Beads
ACYST™ or DURASPHERE FI™ACYST™ or DURASPHERE FI™
Microscopic picture of Microscopic picture of pyrolitic carbon beads pyrolitic carbon beads
Each carbon bead is Each carbon bead is 212-500212-500µmµm
Suspension of carbon Suspension of carbon bead in a gel bead in a gel consisting of water consisting of water and beta-D glucan.and beta-D glucan.
ACYST™ or DURASPHERE FI™ACYST™ or DURASPHERE FI™
-Outpatient, open-label trial-Outpatient, open-label trial-10 patients followed for 12 months-10 patients followed for 12 months-Ambulatory injection of ACYST-Ambulatory injection of ACYSTTM TM carbon carbon
coated beadscoated beads-No changes in the results of anorectal -No changes in the results of anorectal
physiology testing during 12 monthsphysiology testing during 12 months-1 complication consisting of extravasation of -1 complication consisting of extravasation of
beads causing painbeads causing pain
Conclusions - ACYST ™ or Conclusions - ACYST ™ or DURASPHERE FI™DURASPHERE FI™
80% of patients improve following ACYST™ 80% of patients improve following ACYST™ injectionsinjections
23% improvement in incontinence scores from a 23% improvement in incontinence scores from a mean of 13 preprocedure to 10 at 3mosmean of 13 preprocedure to 10 at 3mos
30% improvement in incontinence scores at 30% improvement in incontinence scores at 6mos(6pts) ICS 9.3 6mos(6pts) ICS 9.3
Improvement in FIQL scores in all 4 scales at 3 Improvement in FIQL scores in all 4 scales at 3 monthsmonths
Conclusions: Injectable Silicone Conclusions: Injectable Silicone and ACYSTand ACYST
SimpleSimple Office BasedOffice Based AmbulatoryAmbulatory Moderate to severe incontinenceModerate to severe incontinence Good short term outcomeGood short term outcome Minimal complications Minimal complications
CCF FI score improved from 13.8 to 7.3 (p<0.002)CCF FI score improved from 13.8 to 7.3 (p<0.002) All FIQOL parameters improved (p<0.01)All FIQOL parameters improved (p<0.01)
Social function SF 36 improved (p=0.04)Social function SF 36 improved (p=0.04) Use of pads eliminated in 4 of 7 patientsUse of pads eliminated in 4 of 7 patients No significant changes between 12 and 24 monthsNo significant changes between 12 and 24 months No long term complicationsNo long term complications
Takahashi et al, DCR, 2003Takahashi et al, DCR, 2003
5 centers, open label, prospective trial5 centers, open label, prospective trial 43 Females, 7 males43 Females, 7 males Mean age: 61.1 (30-80) yearsMean age: 61.1 (30-80) years Mean length of fecal incontinence: 14.9 yearsMean length of fecal incontinence: 14.9 years 11 (22%) patients had previous surgery for fecal incontinence11 (22%) patients had previous surgery for fecal incontinence
ResultsResultsEffect on Anorectal PhysiologyEffect on Anorectal PhysiologyAnal manometryAnal manometry Significant reduction in both threshold and maximal Significant reduction in both threshold and maximal
rectal volumesrectal volumes No changes in anal resting or squeeze pressuresNo changes in anal resting or squeeze pressures
Endoanal UltrasoundEndoanal Ultrasound No changeNo change
Pudendal Nerve Terminal Motor LatencyPudendal Nerve Terminal Motor Latency No changeNo change
Efron et al, DCR 2003Efron et al, DCR 2003
RadiofrequencyRadiofrequency1 year results1 year results
10 female patients10 female patients– FI for at least 3 months, 1x/weekFI for at least 3 months, 1x/week– Failed biofeedback and conservative RxFailed biofeedback and conservative Rx
Age: 55.9 (range 44-74) yearsAge: 55.9 (range 44-74) years Sedation and local anesthesiaSedation and local anesthesia Procedure time: 65.4 minutesProcedure time: 65.4 minutes RF energy delivery time: 27.7 minutesRF energy delivery time: 27.7 minutes
Takahashi et al, DCR, 2002Takahashi et al, DCR, 2002
Radiofrequency:Radiofrequency:1 year results1 year results
– Anoscopy: normal Anoscopy: normal – Manometry:Manometry: in initial and max tolerable volumes in initial and max tolerable volumes– EAUS: no new defects or scar tissue EAUS: no new defects or scar tissue
Takahashi et al, DCR, 2002Takahashi et al, DCR, 2002
Radiofrequency: Radiofrequency: 1 year follow-up1 year follow-up
One year follow-upOne year follow-up CCF Incontinence score improved (13.5 to 5; p<0.001)CCF Incontinence score improved (13.5 to 5; p<0.001) All FIQOL parameters improved (p<0.05)All FIQOL parameters improved (p<0.05)
- - Life styleLife style - Coping - Coping
- Depression - Depression - Embarrassment- Embarrassment Use of pads eliminated in 5 of 7 patientsUse of pads eliminated in 5 of 7 patients
Takahashi et al, DCR, 2002Takahashi et al, DCR, 2002
10 females10 females CCF FI score improved from 13.8 to 7.3 (p<0.002)CCF FI score improved from 13.8 to 7.3 (p<0.002) All FIQOL parameters improved (p<0.01)All FIQOL parameters improved (p<0.01)
Social function SF 36 improved (p=0.04)Social function SF 36 improved (p=0.04) Use of pads eliminated in 4 of 7 patientsUse of pads eliminated in 4 of 7 patients No significant changes between 12 and 24 monthsNo significant changes between 12 and 24 months No long term complicationsNo long term complications
ABS: Safety and efficacy ABS: Safety and efficacy Multicenter, prospective, non-randomizedMulticenter, prospective, non-randomized 112 patients were implanted112 patients were implanted Mean age 49 (range 18-81) yearsMean age 49 (range 18-81) years 384 device related adverse events in 99 patients384 device related adverse events in 99 patients 246 required either no or non-invasive intervention246 required either no or non-invasive intervention 73 revisional operations in 51(46%) patients73 revisional operations in 51(46%) patients Infection requiring surgical revision was 25%Infection requiring surgical revision was 25% 41(37%) patients had devices completely explanted41(37%) patients had devices completely explanted
– 7 had successful reimplantations7 had successful reimplantations
Wong et al, DCR, 2002Wong et al, DCR, 2002
Functioning sphincter: improved QOL and anal Functioning sphincter: improved QOL and anal continencecontinence
FI (scale, 1-120) scores improved FI (scale, 1-120) scores improved from 105 to 51 (63 patients at 6 months)from 105 to 51 (63 patients at 6 months) from 105 to 48 (55 patients at 12 months)from 105 to 48 (55 patients at 12 months) Successful outcome in 85% with functioning deviceSuccessful outcome in 85% with functioning device Intention to treat success rate of 53%Intention to treat success rate of 53% Conclusion:Conclusion: High morbidity and need for revisional surgeryHigh morbidity and need for revisional surgery Improve FI and QOL in patients with severe FIImprove FI and QOL in patients with severe FI
Wong et al, DCR, 2002Wong et al, DCR, 2002
ABS: Safety and efficacy ABS: Safety and efficacy
ABS: Long –Term ResultsABS: Long –Term Results
Group I: 1989 – 1986Group I: 1989 – 1986 n=10n=10 Mean age 35 (15-52 Mean age 35 (15-52
Success not improved with timeSuccess not improved with time Infection remains major challengeInfection remains major challenge Once implanted remains stable Once implanted remains stable
ABS: Long-Term Results ABS: Long-Term Results
Parker et al, DCR 2003
ABS: Other seriesABS: Other series
Author/yrAuthor/yr n F-U Morbidity Device n F-U Morbidity Device SuccessSuccess (mos) (%) (mos) (%) expl/impl (n) (%) expl/impl (n) (%)
Devesa and Fernandez, Semin in CRS 1997Devesa and Fernandez, Semin in CRS 1997
Dynamic graciloplastyDynamic graciloplasty
Dynamic Graciloplasty: Dynamic Graciloplasty: safety and efficacysafety and efficacy
Prospective multicenter trialProspective multicenter trial 20 institutions20 institutions 123 patients123 patients 14 day diaries14 day diaries 189 adverse events in 91 patients (74%)189 adverse events in 91 patients (74%) 49 patients required 1 or more operations (40%)49 patients required 1 or more operations (40%) 170 (90%) events were resolved170 (90%) events were resolved
Baeten et al, DCR, 2000Baeten et al, DCR, 2000
Success: 50% or > decrease in incontinent events Success: 50% or > decrease in incontinent events No pre-existing stomaNo pre-existing stoma
63% at 12 months63% at 12 monthsAdditional 11% lesser degree of improvementAdditional 11% lesser degree of improvement
Pre-existing stomasPre-existing stomas33% at 12 months33% at 12 months60% at 18 months60% at 18 months
Conclusion:Conclusion: Objective improvement in majority of patients Objective improvement in majority of patients Adverse events are frequently encountered, but Adverse events are frequently encountered, but
most resolve with treatmentmost resolve with treatmentBaeten et al, DCR, 2000Baeten et al, DCR, 2000
Dynamic Graciloplasty: Dynamic Graciloplasty: safety and efficacysafety and efficacy
129 patients 129 patients
– Europe: 67Europe: 67
– USA 45USA 45
– Canada:17Canada:17
20 investigative sites20 investigative sites
27 pre-existing stoma27 pre-existing stoma
88 no stoma at enrollment88 no stoma at enrollment
Wexner et al, DCR, 2002Wexner et al, DCR, 2002
Dynamic Graciloplasty: Dynamic Graciloplasty: Long term efficacyLong term efficacy
Success: >50% decrease in FI episodesSuccess: >50% decrease in FI episodesIn non-stoma patients In stoma patientsIn non-stoma patients In stoma patients 62% - 12 months62% - 12 months 37.5% -12 months37.5% -12 months55% - 18 months55% - 18 months 62% -18 months62% -18 months56% - 24 months56% - 24 months 43% -24 months43% -24 months
QOL: SF 36, significant improvement QOL: SF 36, significant improvement
Conclusion:Conclusion: Dynamic graciloplasty successful in majority of patients with end Dynamic graciloplasty successful in majority of patients with end
stage FIstage FI Persisted at 2 years follow upPersisted at 2 years follow up
Wexner et al, DCR, 2002Wexner et al, DCR, 2002
Dynamic Graciloplasty: Dynamic Graciloplasty: Long term efficacyLong term efficacy
200 consecutive patients (153 females)200 consecutive patients (153 females) 48 (15-77) years48 (15-77) years 261 weeks median follow-up261 weeks median follow-up
72% overall success72% overall success 16% disordered evacuation16% disordered evacuation 405 weeks median battery life405 weeks median battery life
Rongen et al, DCR 2003Rongen et al, DCR 2003
Dynamic Graciloplasty: Dynamic Graciloplasty: 2 Year Follow-up2 Year Follow-up
SACRAL NERVE STIMULATION SACRAL NERVE STIMULATION SINGLE CENTER SERIESSINGLE CENTER SERIES
15 patients: temporary then permanent SNS15 patients: temporary then permanent SNS Median age 60 (range 37-71) yearsMedian age 60 (range 37-71) years Median FU: 24 (3-60) monthsMedian FU: 24 (3-60) months 11 fully continent11 fully continent episodes of FI after stimulation episodes of FI after stimulation (median, 11-0, (median, 11-0,
p<0.001)p<0.001)
Kenefick et al, Br J Surg, 2002Kenefick et al, Br J Surg, 2002
SACRAL NERVE STIMULATIONSACRAL NERVE STIMULATION SINGLE CENTER SERIESSINGLE CENTER SERIES
Urgency improved in all patients Urgency improved in all patients (median,1-8, p=0.01)(median,1-8, p=0.01)
Improvement in mean resting pressure Improvement in mean resting pressure (p<0.05)(p<0.05)
Mean squeeze pressure increment 43 vs 69 Mean squeeze pressure increment 43 vs 69 (p<0.01)(p<0.01)
SF 36: significant improvementSF 36: significant improvement No major complications No major complications
Conclusion:Conclusion:
Safe,effective, minimal morbidity,benefit maintained medium Safe,effective, minimal morbidity,benefit maintained medium
termterm
Kenefick et al, Br J Surg, 2002Kenefick et al, Br J Surg, 2002
2 women (65 and 61)2 women (65 and 61) Both received permanent stimulatorBoth received permanent stimulator Each was turned on for 2 weeks and off for Each was turned on for 2 weeks and off for
2 weeks, and visa versa2 weeks, and visa versa Patients and investigators were blindedPatients and investigators were blinded Statistically significant decrease in number Statistically significant decrease in number
of incontinent episodes when the stimulator of incontinent episodes when the stimulator was onwas on
Vaizey, DCR 2000
SACRAL NERVE STIMULATIONSACRAL NERVE STIMULATIONLARGEST SINGLE CENTER SERIESLARGEST SINGLE CENTER SERIES
Patients - 75Patients - 75 Mean age - 52Mean age - 52 Median duration of FI – 5 years (1-66) Median duration of FI – 5 years (1-66) Temporary electrodes Temporary electrodes
– not placed in 2 patientsnot placed in 2 patients– Improved continence in 62%Improved continence in 62%
After placement of permanent electrodes – improvement After placement of permanent electrodes – improvement sustainedsustained
At 1 year, success rate of 76% for improved continenceAt 1 year, success rate of 76% for improved continence
37 patients, permanent stimulator in 3437 patients, permanent stimulator in 34 Followed 24 monthsFollowed 24 months Improved:Improved:
– Incontinent episodes per week (p<0.0001)Incontinent episodes per week (p<0.0001)– Staining (p<0.0001)Staining (p<0.0001)– Pad use (p<0.0001)Pad use (p<0.0001)– Ability to postpone defecation (p<0.0001)Ability to postpone defecation (p<0.0001)– Ability to completely empty the bowel (p<0.0001)Ability to completely empty the bowel (p<0.0001)
Quality of life improvedQuality of life improved– 4/4 ASCRS scales (p<0.0001)4/4 ASCRS scales (p<0.0001)– 7/8 SF-36 scales though only social functioning was significantly 7/8 SF-36 scales though only social functioning was significantly
Most patients experienced improvement by 75%Most patients experienced improvement by 75% Effects were consistent up to 99 monthsEffects were consistent up to 99 months Improvements in:Improvements in:
– IncontinenceIncontinence– Ability to postpone defecationAbility to postpone defecation– Ability to empty rectumAbility to empty rectum
Complication rate 0-50%Complication rate 0-50%– Pain at site of generator, electrode dislodgement, Pain at site of generator, electrode dislodgement,
infection, loss of effect, deterioration of functioninfection, loss of effect, deterioration of function
SNS is effective SNS is effective Consistent over timeConsistent over time FIQOL significantly improved in single and FIQOL significantly improved in single and
