New Surgical Advances in the Treatment of Fecal Incontinence Steven D Wexner, M.D., FACS, FRCS, FRCS (Ed) Chairman, Department of Colorectal Surgery Cleveland.
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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
Injectable siliconeInjectable silicone Injectable submucosal beads (ACYSTInjectable submucosal beads (ACYSTTMTM)) Radiofrequency (SECCARadiofrequency (SECCATMTM)) Artificial Bowel SphincterArtificial Bowel Sphincter Unstimulated Bilateral GluteoplastyUnstimulated Bilateral Gluteoplasty Stimulated GraciloplastyStimulated Graciloplasty Sacral Nerve StimulationSacral Nerve Stimulation
New Surgical Treatments for New Surgical Treatments for Fecal IncontinenceFecal Incontinence
OVERLAPPING SPHINCTER OVERLAPPING SPHINCTER REPAIR: SHORT TERMREPAIR: SHORT TERM
AuthorAuthor YearYear nn Obstetric/Obstetric/ Results Results Operative trauma Excellent Fair Operative trauma Excellent Fair
PoorPoor
Fleshman 1991 55 100 72 22 6
Wexner 1991 16 100 76 19 5
Fleshman 1991 28 100 75 21 4
Engel 1994 55 100 76 24
Engel 1994 28 53 75 25
Simmang 1994 14 79 93 7
OVERLAPPING SPHINCTER OVERLAPPING SPHINCTER REPAIR: SHORT TERMREPAIR: SHORT TERM
AuthorAuthor YearYear nn Obstetric/Obstetric/ Results (%)Results (%)Operative trauma Operative trauma
Excellent PoorExcellent Poor
Londono-Londono- 19941994 128128 6464 5050 50 50
OliveiraOliveira 19961996 5555 8484 7171 2929
Felt-BersmaFelt-Bersma 19961996 1818 3939 7272 2828
NikiteasNikiteas 19961996 4242 2626 6767 3333
SitzlerSitzler 19961996 3131 6464 7474 2626
TernentTernent 19971997 1616 100100 6262 3838
Barisic 2006 65 86 74 26Barisic 2006 65 86 74 26
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
3 month:3 month: - 55.5% excellent- 55.5% excellent - 18.5% good- 18.5% good - 16.9% fair - 16.9% fair - 9.2% poor- 9.2% poor
Barisic, Int J Colorectal Dis, 2006
80 month:80 month: - 26.8% excellent- 26.8% excellent - 21.4% good- 21.4% good - 12.5% fair- 12.5% fair - 39.3% poor- 39.3% poor
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
NeuropathyNeuropathy NeuropathyNeuropathy
Laurberg, 88Laurberg, 88 1919 80%80% 11%11% <0.05 <0.05
Simmans, 94Simmans, 94 1414 100%100% 67%67% ------
Londono, 94Londono, 94 9494 55%55% 30%30% <0.001 <0.001
Stitzler, 96Stitzler, 96 3131 67%67% 63%63% ------
Sangwan, 96Sangwan, 96 1515 100%100% 14%14% <0.005<0.005
GillilandGilliland , 98, 98 7777 62%62% 17%17% <0.01<0.01
OVERLAPPING OVERLAPPING SPHINCTEROPLASTYSPHINCTEROPLASTY
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
latencylatency EndosonographyEndosonography
OVERLAPPING OVERLAPPING SPHINCTEROPLASTYSPHINCTEROPLASTY
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?
0
5
10
15
20
1 2 3 4 5
PreoperativePreoperative PostoperativePostoperative
Inco
ntin
ence
sc o
reIn
cont
ine n
ce s
core
PatientsPatients
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?
0
5
10
15
20
1 2 3 4 5 6 7
PreoperativePreoperative PostoperativePostoperative
Inco
ntin
ence
sc o
reIn
cont
ine n
ce s
core
PatientsPatients
Incontinence score pre and post operative overlapping scar-scarIncontinence score pre and post operative overlapping scar-scar
POSTANAL REPAIRPOSTANAL REPAIR
Results (%)Results (%)InstitutionInstitution YearYear Number Number Excellent/Excellent/ FairFair
PoorPoor patients patients GoodGoodKeighleyKeighley 19821982 114 114 32 32 ---- 9 9
HenryHenry 19831983 204 204 58 58 1212 30 30
BrowningBrowning 19831983 42 42 81 81 1919 17 17
FergusonFerguson 19841984 9 9 67 67 2222 11 11
POSTANAL REPAIRPOSTANAL REPAIR
Results (%)Results (%)InstitutionInstitution YearYear Number Number Excellent/Excellent/ FairFair
PoorPoor patients patients GoodGood
VroonhavenVroonhaven 19841984 16 16 7070 ---- 2525
WomackWomack 19881988 16 16 8787 00 1313
ScheuerScheuer 19891989 39 39 4343 2626 3131
OrromOrrom 19911991 17 17 5959 1717 2424
POSTANAL REPAIRPOSTANAL REPAIR
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
monthsmonths 35% success35% success
– Preoperative incontinence score - 16.7Preoperative incontinence score - 16.7– Postoperative incontinence score - 2.6Postoperative incontinence score - 2.6
Matsuoka, DCR 2000
INJECTION OF INJECTION OF AUTOLOGOUS FATAUTOLOGOUS FAT
14 patients (9 F, 5 M; age range 38-62 years)14 patients (9 F, 5 M; age range 38-62 years) Causes of incontinenceCauses of incontinence
– IdiopathicIdiopathic 66– HemorrhoidectomyHemorrhoidectomy 33– Internal sphincterotomyInternal sphincterotomy 44– Perianal tearPerianal tear 11
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)
Malouf et al. DCR 2001
6 weeks 6 weeks – Complete resolution: 3Complete resolution: 3
– Improved: 3Improved: 3
– 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
Radiofrequency (SECCARadiofrequency (SECCATMTM))
Temperature-controlled radiofrequency deliveryTemperature-controlled radiofrequency delivery
Temperature Ramp-up during RF delivery
RadiofrequencyRadiofrequency
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)
- Lifestyle- Lifestyle - Coping- Coping
- Depression- Depression - Embarrassment- Embarrassment
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
Radiofrequency: 2 year-results Radiofrequency: 2 year-results
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
– 9.18% Sphincter repair9.18% Sphincter repair– 2.4% Artificial bowel sphincter2.4% Artificial bowel sphincter
6 months follow-up6 months follow-up Mean treatment time: 37 Mean treatment time: 37 ++ 9 minutes 9 minutes
Efron et al, DCR 2003Efron et al, DCR 2003
Radiofrequency:Radiofrequency:6 month follow-up 6 month follow-up
Efron et al, DCR 2003Efron et al, DCR 2003
RadiofrequencyRadiofrequencyFecal Incontinence Fecal Incontinence
6 months6 months14.5
11.1
0
2
4
6
8
10
12
14
16
Before After
CCF Incontinence Score (0-20) ; p <0.0001
Efron et al, DCR 2003Efron et al, DCR 2003
RadiofrequencyRadiofrequencyFecal Incontinence Quality of LifeFecal Incontinence Quality of Life
6 months6 months
Lifestyle
FIQOL (1 – 4/4.4) ; p <0.0001
2.5
1.9 1.9
3.1
2.4 2.5
2.8
3.3
0
0.5
1
1.5
2
2.5
3
3.5
Before
After
Coping Depression Embarrassment
Efron et al, DCR 2003Efron et al, DCR 2003
RadiofrequencyRadiofrequencySF 36 Quality of LifeSF 36 Quality of Life
6 months6 months
Before After
p <0.003
0
10
20
30
40
50
60
70
80
Social Function
60
62
64
66
68
70
72
74
Mental Health
Before After
p <0.02
Results: ComplicationsResults: Complications
Adverse EventAdverse Event nn %%Mucosal UlcerationsMucosal Ulcerations 22 4 %4 %Bleeding Requiring Intervention Bleeding Requiring Intervention 11 2 %2 %
Minor BleedingMinor Bleeding 55 10 %10 %Antibiotic Induced DiarrheaAntibiotic Induced Diarrhea 77 14 %14 %FeverFever 22 4 %4 %VomitingVomiting 11 2 %2 %ConstipationConstipation 11 2 %2 %Groin swellingGroin swelling 11 2 %2 %Hot flashesHot flashes 11 2 %2 %
Efron et al, DCR 2003Efron et al, DCR 2003
Results: Anorectal ManometryResults: Anorectal Manometry
245
20
110
15
0
50
100
150
200
250
300
Maximum TolerableVolume
Threshold Volume
Vol
ume
(cc)
Baseline6 months
p=0.0009p=0.05
Efron et al, DCR 2003Efron et al, DCR 2003
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
Complications Complications – Bleeding (3 spontaneous resolution, 1 suture Bleeding (3 spontaneous resolution, 1 suture
ligation) ligation) 6 months FU6 months FU
– 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)
- Lifestyle- Lifestyle - Coping- Coping
- Depression- Depression - Embarrassment- Embarrassment
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
Radiofrequency: Radiofrequency: 2 year-results 2 year-results
Takahashi et al, DCR, 2003Takahashi et al, DCR, 2003
Results: 2 year follow-upResults: 2 year follow-upCleveland Clinic Florida-Incontinence ScoreCleveland Clinic Florida-Incontinence Score
*p<0.05 versus baseline
Fecal Incontinence Quality of LifeFecal Incontinence Quality of Life
2.3
1.7
2.4
1.5
3.3
2.7
3.4
2.4
0.0
1.0
2.0
3.0
4.0
Lifestyle Coping Depression Embarrassment
Baseline 2 Years
Results: 2 year follow-upResults: 2 year follow-up
All p<0.01
SF-36 General Quality of LifeSF-36 General Quality of Life
50
38.8
82.5
48.1
20
40
60
80
100
Social Function Mental Component Summary
Baseline 2 Years
Results: 2 year follow-upResults: 2 year follow-up
p=0.004
p=0.11
RadiofrequencyRadiofrequency
Currently, prospective, randomized, sham-Currently, prospective, randomized, sham-controlled trial is underwaycontrolled trial is underway
Safe, effective, minimally invasiveSafe, effective, minimally invasive
Artificial Bowel Sphincter (ABS)Artificial Bowel Sphincter (ABS)
Cuff
Ballon
Pump
FDA approved in 1999
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
years; 3 females)years; 3 females) 6 Functioning6 Functioning 4 Explanted4 Explanted
Group II: 1997-2001Group II: 1997-2001 n=35n=35 Mean age: 47 (18-72 Mean age: 47 (18-72
years; 25 females)years; 25 females) 17 (49%) Functioning17 (49%) Functioning
Parker et al, DCR 2003
45 patients45 patients
14/35 explanted14/35 explanted– 12 (34%) infection 12 (34%) infection – 2 (6%) pain2 (6%) pain
21 revisions (7 complete replacement)21 revisions (7 complete replacement) 19% infection after revision19% infection after revision 4 explanted after revision4 explanted after revision 18 total failures (9 stomas)18 total failures (9 stomas)
ABS: Long-Term Results ABS: Long-Term Results
Parker et al, DCR 2003
Improved quality of life scalesImproved quality of life scales– 6 months and 1 year (p<0.01)6 months and 1 year (p<0.01)
Improved fecal incontinenceImproved fecal incontinence– Severity scores (p<0.001)Severity scores (p<0.001)
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) (%)
Wong, 96Wong, 96 12 12 58 58 3333 -- 75 75Lehur, 98Lehur, 98 13 13 30 30 1818 4/24/2 67 67Vaizey, 98Vaizey, 98 6 6 10 10 3030 1/0 1/0 83 83Christiansen, 99 17Christiansen, 99 17 84 84 3333 7/07/0 47 47O’Brien, 00O’Brien, 00 13 13 -- -- 6161 3/03/0 69 69Lehur, 00Lehur, 00 24 24 20 20 2929 7/37/3 75 75Altomare, 01 28Altomare, 01 28 19 19 3232 7/27/2 66 66Devesa, 02Devesa, 02 53 -- 53 -- 6969 -- -- 65 65Michot, 03Michot, 03 37 -- 37 -- 3737 11/211/2 78.9 78.9Casal, 04 Casal, 04 10 29 60 3/2 90 10 29 60 3/2 90
Unstimulated Bilateral GluteoplastyUnstimulated Bilateral Gluteoplasty
Unstimulated Bilateral Unstimulated Bilateral Gluteoplasty: Early ResultsGluteoplasty: Early Results
PatientsPatients Good Good ResultsResults
Fair Fair ResultsResults
Poor Poor ResultsResults
ChetwoodChetwood 19021902 11 11 ---- ----
ShoemakerShoemaker 19091909 66 66 ---- ----
BistromBistrom 19441944 33 22 11 ----
BruiningBruining 19811981 11 11 ---- ----
ProchiantzProchiantz 19821982 1515 99 11 55
HertzHertz 19821982 55 11 ---- 11
SkefSkef 19831983 11 44 ---- ----
Devesa and Fernandez, Semin in CRS 1997Devesa and Fernandez, Semin in CRS 1997
Unstimulated Bilateral Unstimulated Bilateral Gluteoplasty: Recent ResultsGluteoplasty: Recent Results
PatientsPatients Good Good ResultsResults
Fair Fair ResultsResults
Poor Poor ResultsResults
IwaiIwai 19851985 11 11 ---- ----
Chen Chen 19871987 66 33 11 22
OnishiOnishi 19891989 11 11 ---- ----
PearlPearl 19911991 77 44 22 11
ChristiansChristiansenen
19951995 77 00 33 44
DevesaDevesa 1992, 961992, 96 1717 99 11 77
TOTALTOTAL 7171 42 (59%)42 (59%) 9 (13%)9 (13%) 20(28%)20(28%)
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
CauseCause Patients (n) Patients (n) Success (%) Success (%)
CongenitalCongenital 2828 5252
TraumaTrauma 9898 8282
IdiopathicIdiopathic 5858 7272
NeurologicNeurologic 1616 8080
TotalTotal 200200 7272
Rongen et al, DCR 2003Rongen et al, DCR 2003
Dynamic Graciloplasty: Dynamic Graciloplasty: 2 Year Follow-up2 Year Follow-up
Author, yearAuthor, year nn Follow-up Follow-up (months)(months)
Morbidity Morbidity (%)(%)
Revisional Revisional surgery (%)surgery (%)
Success Success (%)(%)
Christiansen, 98Christiansen, 98 1313 1717 -- -- 8484
Sielezneff, 99 1616 2020 5050 43.743.7 8181
Mavrantonis, 99Mavrantonis, 99 21 IM 21 IM 6 DS6 DS
21 21 12.512.5
-- -- 93 93
10 10
Mander, 99Mander, 99 6464 1010 -- -- 5656
Madoff, 99Madoff, 99 128128 2626 4141 -- 6666
Konsten, 01Konsten, 01 200 IM 200 IM 81 DS81 DS
-- -- 2.7 2.7 26 26
74 74
57 57
Bresler, 02Bresler, 02 2424 ---- 4242 4646 7979
Wexner, 02Wexner, 02 129129 2424 ---- ---- 6262
Rongen, 03Rongen, 03 200200 7272 ---- 6969 7272
Penninckx, 04Penninckx, 04 6060 5353 7777 7777 6161
Dynamic Graciloplasty: Other seriesDynamic Graciloplasty: Other series
IM – Intramuscular, DS – Direct stimulation
Electrically stimulated gracilis Electrically stimulated gracilis neoanal sphincterneoanal sphincter
AuthorAuthor Method (n) Method (n) Type of Type of Follow-upFollow-upSuccessSuccess Stimulation Stimulation (months)(months)
(%)(%)Altomare, 1997 5 incontinence (9) Altomare, 1997 5 incontinence (9) Direct nerve Direct nerve NR NR 4444
4 after APR4 after APRChristiansen,1998 Christiansen,1998 -monolateral(13)-monolateral(13) Intramuscular Intramuscular 1717 8484
Sielezneff, 1999 Sielezneff, 1999 -monolateral(16)-monolateral(16) Intramuscular Intramuscular 2020 8181
Baeten, 1999 * Baeten, 1999 * -monolateral(109)Intramuscular -monolateral(109)Intramuscular 1212 8080
Mavrantonis, 1999 Mavrantonis, 1999 -monolateral(27) Intramuscular -monolateral(27) Intramuscular 12.5-2112.5-21 9393Direct nerveDirect nerve
1010Mander, 1999 * Mander, 1999 * -monolateral(64)-monolateral(64) Intramuscular, Intramuscular, 1010 5656
Direct nerveDirect nerveMadoff, 1999 * Madoff, 1999 * -monolateral(128)Intramuscular -monolateral(128)Intramuscular 26 26 6666
(*Multicenter trials)(*Multicenter trials) Mavrantonis, DCR 1999
Sacral Nerve Stimulation (SNS)Sacral Nerve Stimulation (SNS)
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
SACRAL NERVE STIMULATIONSACRAL NERVE STIMULATIONDOUBLE BLINDED CROSS-OVER TRIALDOUBLE BLINDED CROSS-OVER TRIAL
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
Uludag, DCR 2004
SACRAL NERVE STIMULATIONSACRAL NERVE STIMULATIONMULTICENTERMULTICENTER
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
improved (P=0.0002)improved (P=0.0002)
Matzel, Lancet 2004
SACRAL NERVE STIMULATIONSACRAL NERVE STIMULATIONREVIEWREVIEW
14 studies reviewed (188 patients) in whom 14 studies reviewed (188 patients) in whom permanentpermanent stimulators placedstimulators placed
Numerous indications:Numerous indications:– Previous anorectal surgeryPrevious anorectal surgery– Cauda equina syndromeCauda equina syndrome– SclerodermaScleroderma– IdiopathicIdiopathic– Obstetric traumaObstetric trauma– TraumaTrauma– Spinal cord lesionSpinal cord lesion– MeningomyeloceleMeningomyelocele– Multpile sclerosisMultpile sclerosis
Matzel, DCR 2004
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
SACRAL NERVE STIMULATIONSACRAL NERVE STIMULATIONREVIEWREVIEW
Matzel, DCR 2004
Double-blind Multicenter 34 patients (31 women) 57 (33-73) years old 27/34 “on” or “off” x 1 month periods
SACRAL NERVE STIMULATIONSACRAL NERVE STIMULATIONCROSSOVER STUDYCROSSOVER STUDY
Leroi et al Ann Surg 2005
SACRAL NERVE STIMULATIONSACRAL NERVE STIMULATIONCROSSOVER STUDYCROSSOVER STUDY
CharacteristicCharacteristicStudy GroupStudy Group
(n = 34)(n = 34)
Duration of incontinenceDuration of incontinence
<1 yr<1 yr
1–5 yr1–5 yr
5–10 yr5–10 yr
>10 yr>10 yr
1212
12 (2)12 (2)
4 (2)4 (2)
6 (1)6 (1)
Type of incontinenceType of incontinence
Urge (inability to defer defecation)Urge (inability to defer defecation)
Passive (no awareness of loss of stool)Passive (no awareness of loss of stool)
MixedMixed
22 (2) 22 (2)
4 (2) 4 (2)
8 (1)8 (1)
Leroi et al Ann Surg 2005
SACRAL NERVE STIMULATIONSACRAL NERVE STIMULATIONCROSSOVER STUDYCROSSOVER STUDY
CharacteristicCharacteristic Study GroupStudy Group
(n = 34)(n = 34)
Main cause of incontinenceMain cause of incontinence
IdiopathicIdiopathic
Pudendal neuropathyPudendal neuropathy
Postoperative IAS fragmentationPostoperative IAS fragmentation
Primary IAS degenerationPrimary IAS degeneration
18 (3) 18 (3)
14 (2)14 (2)
11
11
Previous surgical proceduresPrevious surgical procedures
Sphincter repairSphincter repair
Prolapse repairProlapse repair
Pelvic floor repairPelvic floor repair
3 (2) 3 (2)
2 2
11
Ultrasound findingsUltrasound findings
IAS defectIAS defect
EAS defectEAS defect
7 (2)7 (2)
7 (1)7 (1)
Leroi et al Ann Surg 2005
SACRAL NERVE STIMULATIONSACRAL NERVE STIMULATIONCROSSOVER STUDYCROSSOVER STUDY
Leroi et al Ann Surg 2005
SACRAL NERVE STIMULATIONSACRAL NERVE STIMULATIONCROSSOVER STUDYCROSSOVER STUDY
VariableVariable On vs Off (On vs Off (P P Value)Value)
Greater ImprovementGreater Improvement 0.020.02
Patient PreferencePatient Preference 0.020.02
Frequency of IncontinenceFrequency of Incontinence 0.0050.005
Ability to Postpone Evacuation Ability to Postpone Evacuation 0.010.01
CCF/Wexner Incontinence ScoreCCF/Wexner Incontinence Score 0.00040.0004
Quality of LifeQuality of Life < 0.05< 0.05
Anal Sphincter FunctionAnal Sphincter Function
Maximum RestingMaximum Resting 0.020.02
Leroi et al Ann Surg 2005
Author, year n Follow-up (months)
Score Improvement
Malouf, 00Malouf, 00 55 1616 WexnerWexner 16 -> 216 -> 2
Ganio, 01 1616 15.515.5 WilliamsWilliams 4.1 -> 1.254.1 -> 1.25
Matzel, 01Matzel, 01 66 5-665-66 WexnerWexner 17-> 217-> 2
Rosen, 01Rosen, 01 1616 ---- FI episodesFI episodes 6 -> 26 -> 2
Leroi, 01Leroi, 01 66 66 UrgencyUrgency 4.8 -> 2.34.8 -> 2.3
Ripetti, 02Ripetti, 02 44 1515 WexnerWexner 12.2 -> 9.812.2 -> 9.8
Kenefick, 02Kenefick, 02 1414 2424 FI episodesFI episodes 11-> 011-> 0
Uludag, 04Uludag, 04 7575 1212 FI episodesFI episodes 7.5-> 0.677.5-> 0.67
Matzel, 04Matzel, 04 3434 2424 FI episodesFI episodes 16.4->2.016.4->2.0
Jarrett, 04Jarrett, 04 5959 1212 WilliamsWilliams 7.5 -> 17.5 -> 1
Rasmussen, 04Rasmussen, 04 4545 66 WexnerWexner 16 ->616 ->6
SNS: Permanent implant resultsSNS: Permanent implant results
SACRAL NERVE STIMULATIONSACRAL NERVE STIMULATIONREVIEW – QUALITY OF LIFEREVIEW – QUALITY OF LIFE
SF-36SF-36 FIQOLFIQOL
Categories Categories ImprovedImproved
LifestyleLifestyle Coping/Coping/
BehaviorBehavior
Depression/ Depression/ Self-Self-perceptionperception
Embar-Embar-rassmentrassment
Malouf, 00Malouf, 00 MostMost ---- ---- ---- ----
Rosen, 01Rosen, 01 ---- IncreasedIncreased IncreasedIncreased IncreasedIncreased IncreasedIncreased
Kenefick, 02Kenefick, 02 MostMost ---- ---- ---- ----
Ripetti, 02Ripetti, 02 MostMost ---- ---- ---- ----
Matzel, 04Matzel, 04 ---- IncreasedIncreased IncreasedIncreased IncreasedIncreased IncreasedIncreased
Altomare, Altomare, 0404
---- IncreasedIncreased IncreasedIncreased IncreasedIncreased IncreasedIncreased
Matzel, 04Matzel, 04 MostMost IncreasedIncreased IncreasedIncreased IncreasedIncreased IncreasedIncreased
Matzel, DCR 2004
SACRAL NERVE STIMULATIONSACRAL NERVE STIMULATIONREVIEW – ANORECTAL PHYSIOLOGYREVIEW – ANORECTAL PHYSIOLOGY
Resting PResting P Squeeze PSqueeze P Threshold VThreshold V Urge VUrge V Max Max Tolerable VTolerable V
MaloufMalouf NENE InconsistentInconsistent NENE NENE IncreasedIncreased
MatzelMatzel NENE IncreasedIncreased NENE NENE NENE
GanioGanio IncreasedIncreased IncreasedIncreased DecreasedDecreased DecreasedDecreased DecreasedDecreased
LeroiLeroi NENE InconsistentInconsistent
RosenRosen IncreasedIncreased IncreasedIncreased DecreasedDecreased DecreasedDecreased NENE
UludagUludag NENE NENE ---- ---- ----
KenefickKenefick NENE IncreasedIncreased DecreasedDecreased NENE DecreasedDecreased
RipettiRipetti IncreasedIncreased IncreasedIncreased DecreasedDecreased NENE ----
MatzelMatzel NENE IncreasedIncreased DecreasedDecreased NENE IncreasedIncreased
AltomareAltomare NENE NENE NENE DecreasedDecreased NENE
GanioGanio IncreasedIncreased IncreasedIncreased DecreasedDecreased DecreasedDecreased ----
NE – no effect Matzel, DCR 2004
SNS is effective SNS is effective Consistent over timeConsistent over time FIQOL significantly improved in single and FIQOL significantly improved in single and
muticenter studiesmuticenter studies– LifestyleLifestyle– Coping,/behaviorCoping,/behavior– Depression/self-perceptionDepression/self-perception– EmbarrassmentEmbarrassment
Changes in anorectal physiology testing - variableChanges in anorectal physiology testing - variable
SACRAL NERVE STIMULATIONSACRAL NERVE STIMULATIONREVIEW - CONCLUSIONSREVIEW - CONCLUSIONS
Matzel, DCR 2004
SACRAL NERVE STIMULATIONSACRAL NERVE STIMULATIONREVIEWREVIEW
106 reports reviewed106 reports reviewed 266 underwent temporary stimulation266 underwent temporary stimulation 149 underwent permanent stimulator 149 underwent permanent stimulator (60%)(60%) 41-75% achieved complete continence41-75% achieved complete continence 75-100% experienced improvement75-100% experienced improvement
Jarrett, BJS 2004
Isolated sphincter defect
Pudendal neuropathy
Sphincteroplasty
Alternative procedure
Simple procedures
Success
Complex procedures
Intactrepair
ACYST
SECCA
Perianal sepsis
SNS
Stim’d graciloplasty
ABS
Severe muscle loss
Cardiac pacemaker
yes no
?yes
Failure
Spinal deformity
SNS
ABS, SECCA, ACYST
SNS, SG
SNS
Persistent Defect
no
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