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Yosef Nasseri M.D.Yosef Nasseri M.D.
Fecal Incontinence – A Novel Therapy
Colorectal SurgeryColorectal Surgery
Agenda
♦ Overview of Fecal Incontinence
♦ Conservative Therapy
♦ Surgical management
♦ Cutting Edge Colorectal Surgery
Overview of Fecal Incontinence
♦ Mechanism of Action
♦ Prevalence and Burden
♦ Patient Quality of Life
♦ Typical Treatment Pathway
Mechanism of Action
VIDEO
Fecal Incontinence-More Common Than You Might Think
● It is estimated that more than 18 million adults in the United States
● 1 in 12 suffer from fecal incontinence (FI)
● FI is nearly as prevalent as many other chronic diseases and more prevalent than other illnesses well-known to impact many Americans
0
5
10
15
20
25
30
35
OAB Asthma Diabetes FI Osteoporosis Alzheimer's
FI Impacts Quality of Life
Fecal Incontinence Quality of Life Scale (FIQOL) ScoresNote: Higher scores translate to higher quality of life
Optimal Medical Therapy
♦ Conservative treatments include:
● Dietary changes
● Fiber supplements
● Anti-diarrheal medications
● Biofeedback
Diagnostic Workup
♦ Endoanal Ultrasound
♦ Anal Manometry
♦ Electromyography (EMG)
Surgical management
♦ Repair ● Sphincteroplasty ● Postanal repair
♦ Augmentation ● Injectables ● Radiofrequency
♦ Replacement ● Dynamic Graciloplasty ● Artificial Bowel Sphincter
♦ Stimulation ● Sacral Nerve Stimulation
Long-term Outcomes of Overlapping Sphincteroplasty:
Meta-analysis
♦ 16 studies
♦ 900 patients
♦ Variable outcome measures
♦ Clear trend toward decay of functional outcomes over time
♦ No predictors for long-term success
Glascow et al. DCR 2012
Long-term Outcomes of Overlapping Sphincteroplasty:
Meta-analysis
Glascow et al. DCR 2012
Augmentation Methods
♦ Injectables
♦ Radiofrequency
Results of Injectables
Author N Material
used
Follow-up
(months)
Wexner Incontinence score
Before After
Shafik et al. 14 Autologous Fat 24 85% improved
Shafik et al. 11 PTFE 24 63% improved
Malouf et al. 10 Bioplastique ® 6 30% improved
Tjandra et al. 82 Silicone 12 50% improved
Tjandra et al. 20 PTQ ® 12 12 4
Sorensen et al. 33 Silicone 12 13 10
Weiss et al. 10 ACYST ® 22 13 10
Results of Injectables
Author NMaterial
used Follow-up (months)
Wexner Incontinence score
Before After
Davis et al. 18 Dursphere® 29 11.8 8
Chan et al. 7 PTQ ® 14 9-14 1-5
Stojkovic et al. 73 Contigen ® 12 10 6
De la Portilla et al. 20 PTQ ® 24 13.5 9.4
Maeda et al. 10Bulkamid ®
1915 12
Permacol ® 16 15
Schwander et al. 21 Hyarulonic 20 17 12
Graf et al. 206 Solesta ® 12 10 5
Radiofrequency (SECCATM)
Radiofrequency (SECCATM)
Results of Radiofrequency
Author (year) nF/U
(months)
Wexner Score
QOLBefore After
Takahashi 2002 10 12 13.5 5 ↑
Efron 2003 50 6 14.5 11 ↑
Takahashi 2003 10 24 13.8 7 ↑
Felt-Bersma 2007 11 12 18.8* 15* ↑
Takahashi 2008 19 60 14.4 8 ↑
Lefebure 2008 15 12 14.7 12.3 ↑**
Kim 2009 8 6 13.6 9.9 -
Walega 2009 20 6 Improved ↑
Ruiz 2010 16 12 15.6 12 ↑
Herman 2011 40 12 16 10.9 ↑
Abbas 2012 27 36 Only 22% improved --
* Vaizey score ** only depression improved
Artificial Bowel Sphincter (ABS)
Cuff
Balloon
Pump
FDA approved in 1999
Outcomes of Artificial Bowel Sphincter
Author n F/U (months)
Infection (%)
Explant/Reimplant Functional(%)
Wong 1996 12 58 25 7/4 75
Lehur 1998 13 30 8 4/2 85
Vaizey 1998 6 10 33 1/0 83
Christiansen 1999 17 60 18 7/0 53
Lehur 2000 24 20 4 8/4 83
Dodi 2000 8 10.5 25 2/0 75
O’Brien 2000 13 - 23 3/0 77
Altomare 2001 28 19 18 5/0 75
Lehur 2002 16 25 0 6/1 75
Devesa 2002 53 26.5 21 12/2 49
Ortiz 2002 22 28 9 9/2 68
Wong 2002 112 12 38 41/7 67
Michot 2003 25 34.1 12 5/0 76
Parker 2003 37 12 19 27/7 49
Casal 2004 10 29 10 3/2 90
Ruiz-Carmona 2008 17 68 29 11/3 53
Wexner 2009 47 39 41 18/4 65
Factors associated with ABS failure
♦ 51 ABS in 47 patients
♦ Mean age: 48.8 years
♦ Mean Wexner score: 18 (0-20)
♦ Etiology of incontinence:
● Imperforate anus: 24 (54%)
● Obstetric injury / anorectal surgery: 15 (24%)
● Other: 12 (22%)
Wexner et al. DCR. 2009
Factors associated with ABS failure
♦ Infection 23 (41%)
♦ Non significant factors on univariate analysis:● Age● Gender● BMI● Diabetes Mellitus● Etiology● Stoma● Perianal infection / surgery
Early 18
(35%)
Late 5
(6%)
Wexner et al. DCR. 2009
Factors associated with ABS failure
♦ Multivariate analysis:
♦ Time between ABS implantation to 1st bowel
movement
♦ History of perianal sepsis
♦ Late failures
● More often due to device malfunction
● Indicated the need for mechanical refinement
Wexner et al. DCR. 2009
Sacral Neuromodulation
Sacral Neuromodulation
An established therapy that expands your treatment options for patients with chronic fecal incontinence who have failed or are not candidates for more conservative treatments.
Sacral NeuromodulationMechanism of action
VIDEO
Sacral NeuromodulationMechanism of action
♦ Focuses mild electrical pulses on the nerves that control the pelvic floor muscles, anal sphincters, and colon
♦ Either an excitation of parasympathetic nerves or a release from the inhibition of the sympathetic nerves (or both) may be hypothesized
Author n F/U (months) Scoring Method Before After p
Malouf (2000) 5 16 Wexner 16 2 <0.01
Ganio (2001) 16 15.5 Williams 4.1 1.25 0.01
Leroi (2001) 6 6 FI episodes/ 1wk 3.2 0.05 < 0.05
Matzel (2001) 6 5-66 Wexner 17 2 NR
Rosen (2001) 16 15 FI episodes/3 wks 6 2 NR
Kinefick (2002) 15 24 FI episodes/1 wk 11 0 <0.001
Jarrett (2004) 46 12 FI episodes/1 wk 7.5 1 <0.001
Matzel (2004) 34 24 FI episodes/1 wk 16.4 2.0 <0.0001
Rasmussen (2004) 45 6 Wexner 16 6 <0.0001
Uludag (2004) 75 12 FI episodes/1 wk 7.5 0.67 <0.01
Holzer (2007) 29 35 FI episodes/3 wks 7 2 0.002
Hetzer (2007) 37 13 Wexner 16 5 <0.01
Sacral Nerve Stimulation Results
Author n F/U (months) Scoring Method Before After p
Melenhorst (2007) 100 36 FI episodes/1 wk 31.3 4.8 <0.0001
Matzel (2008) 9 117.6 Wexner 17 10 <0.007
Tjandra (2008) 53 12 Wexner 16 1.2 <0.0001
Altomare (2009) 52 60 Wexner 15 5 < 0.001
Boyle (2009) 13 3-6 Wexner 12 9 0.0005
Dudding (2010) 9 46 FI episodes/1 wk 9.9 1.0 0.031
Michelsen (2010) 177 24 Wexner 16 10 <0.0001
Vallet (2010) 23 44 Wexner 16 6.9 NR
Wexner (2010) 120 28 FI episodes/1 wk 9.4 2.7 <0.0001
Lim (2011) 41 51 Wexner 11.5 8.0 <0.001
George (2012) 25 114 FI episodes/wk 22 0 0.001
Hull (2012) 120 60 FI episodes/wk 9.4 1.7 <0.001
Sacral Nerve Stimulation Results
Sacral nerve Stimulation Meta-Analysis
♦ 34 studies – 665 patients
♦ Significant improvements in Number of incontinent episodes Wexner Fecal Incontinence Score Ability to defer evacuation Most SF-36 and FIQL domains Mean anal resting pressures
15% Morbidity – 3% Explantation
Sacral Nerve Stimulation Sacral Nerve Stimulation Quality of LifeQuality of Life
SF-36 FIQOLCategories Improved
Lifestyle Coping/
Behavior
Depression/ Self-
perception
Embarrassment
Malouf Most – – – –
Rosen – Kenefick Most – – – –
Ripetti Most – – – –
Matzel – Altomare – Matzel Most
Matzel et al. DCR 2004
Demographics 120 Implanted Subjects
♦ Age: 60.5 years (30 - 88)
♦ Gender: 92% female, 8% male
♦ Years with fecal incontinence: 6.8 (1 - 44)
Wexner et al. Ann Surg. 2010
Primary Efficacy Objective: Weekly Incontinent Episodes
Wexner et al. Ann Surg. 2010
73%
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
12-Month (n=120)
Primary Objective
Clin
ical S
uccess R
ate
(%
Su
bje
cts
)
64%
81%
Performance Criterion
Clinical Success: ≥ 50% Reduction in Weekly Incontinent Episodes from Baseline to 12 Months
(p < .0001)
Primary Efficacy Objective: Weekly Incontinent Episodes
Wexner et al. Ann Surg. 2010
Absolute Reduction - Sensitivity Analysis
0.00
1.00
2.00
3.00
4.00
5.00
6.00
7.00
8.00
9.00
10.00
Me
an
We
ek
ly In
co
nti
ne
nt
Ep
iso
de
s
Modified Worst Case Analysis(n=120)
9.39 3.08
LOCF Analysis (n=120) 9.39 2.54
Completers Analysis (n=106) 9.19 1.92
Baseline 12-Month
Secondary Efficacy Objective: Weekly Urgent Incontinent Episodes
Wexner et al. Ann Surg. 2010
% Reduction - Sensitivity Analysis
0.00
1.00
2.00
3.00
4.00
5.00
6.00
Me
an
We
ek
ly U
rge
nt
Inc
on
tin
en
t E
pis
od
es
Worst Case Analysis(n=120)
4.95 1.73
LOCF Analysis (n=120) 4.95 1.36
Completers Analysis (n=106) 4.91 1.15
Baseline 12-Month
Secondary Efficacy Objective: Fecal Incontinence Quality of Life
Wexner et al. Ann Surg. 2010
Mean FIQOL - Multiple Follow-ups
1
1.5
2
2.5
3
3.5
4
Mea
n F
IQO
L S
core
(Co
mp
lete
rs A
nal
ysis
)
Scale 1 - Lifestyle 2.31 3.22 3.26 3.36 3.26 3.41
Scale 2 - Coping/Behavior 1.49 2.64 2.69 2.77 2.67 2.52
Scale 3 - Depression/Self-Perception 2.53 3.33 3.48 3.55 3.61 3.65
Scale 4 - Embarrassment 1.6 2.73 2.75 2.81 2.76 2.65
Baseline (n=119)
3-Month (n=116)
6-Month (n=109)
12-Month (n=107)
24-Month (n=43)
36-Month (n=18)
Additional Study MeasuresSelf-rated Bowel Health
Wexner et al. Ann Surg. 2010
Mean Plot of Changes in Self-rated Bowel Health
7.28
3.53
0.00
1.00
2.00
3.00
4.00
5.00
6.00
7.00
8.00
9.00
10.00
Baseline 12-Months
Mean Change from Baseline to 12 Months (n=106)
Sel
f-ra
ted
Bo
wel
Hea
lth
(p < .0001)
Morbidity Most Frequent Device/Therapy-Related
Adverse Events
Wexner et al. Ann Surg. 2010
♦ Test Stimulation Phase (n=132)
● Implant site pain (3.8%)
● Lead fracture (1.5%)
♦ Implant Phase (n=120)
● Implant site pain (25.8%)
● Implant site infection (10.8%)
● Paraesthesia (10.8%)
● Change in sensation of stimulation (5.8%)
● Diarrhea (5.8%)
● Pain (5%)
● Urinary incontinence (5.0%)
Morbidity Infectious complications
♦ 13 women
♦ Mean age of 54.5 years (33-85)
♦ Mean BMI of 26.4 kg/m2 (19.3-39)
♦ One patient with non-insulin dependant diabetes
♦ Two patients had lower back surgery
♦ No steroid use
Wexner et al. Ann Surg. 2010
Patients with infectious complication (n=13)
Morbidity Infectious complications
Risk Factor No. of patients
Age > 65 4
BMI > 30 3
BMI > 35 2
NIDDM 1
Lower back surgery 2
Steroid use 0
Patients with infectious complication (n=13)
Wexner et al. J Gastrointest Surg 2010
Morbidity Infectious complications
Implant Phase (n=120)
Early events
6 infections were reported at a mean of 11 (range 7-18) days post implant and successfully treated with oral antibiotics
Wexner et al. Ann Surg. 2010
Morbidity Infectious complications
Implant Phase (n=120)
Late events
7 infections were reported at a mean of 7 (range 2-14) months after implant. 6 were totally or partially explanted, 1 successfully re-implanted
Wexner et al. Ann Surg. 2010
SNS Long-term efficacy & Safety120-Patient Prospective Multi-center Study
♦ Mean Follow-up: 36 (2-73) months♦ Therapeutic Success (50% improvement)
● 12 months → 83%● 24 months → 86%● 36 months → 85%
♦ Perfect continence● 12 months → 41%● 24 months → 38%● 36 months → 37%
Wexner et al. Ann Surg. 2010
SNS Long-term efficacy & Safety120-Patient Prospective Multi-center Study
Mellgren et al. DCR 2011
SNS Long-term efficacy & Safety120-Patient Prospective Multi-center Study
Mellgren et al. DCR 2011
SNS Long-term efficacy & Safety120-Patient Prospective Multi-center Study
Mellgren et al. DCR 2011
Significant improvement (p< 0.0001) in all 4 scales of the FIQOL from baseline to 3 years
SNS Long-term efficacy & Safety120-Patient Prospective Multi-center Study
Mellgren et al. DCR 2011
♦ Common adverse events:● Pain: 28%
● Infection: 11%
● Paraesthesia: 14%
SNS for Fecal Incontinence: Long-term durability
Prospective Multi-center Study
Hull et al. DCR 2012
♦ Mean Follow-up: 60.4 (2.2 – 99.2) months♦ 74 patients available at 5 year follow-up♦ FI episodes (p<.001):
● 9.4 episodes/week at baseline● 1.7 episodes/week at 5 yrs
♦ 88% had success (≥ 50% improvement) (p<.001)♦ 36% had complete continence♦ FIQOL scores also significantly improved for all 4 ♦ scales between baseline and 5 yrs (p<.001)
SNS Six Year Follow-UpThe Danish Experience
Michelsen et al. DCR 2010
♦ 2001 - 2007♦ 177 patients underwent PNE test♦ Reasons FI (SNS implanted):
● 46.0% idiopathic● 25.4% traumatic or obstetric● 11.1% anorectal surgery● 17.5% others
♦ 126 had SNS implanted
SNS Six Year Follow-UpThe Danish Experience
Michelsen et al. DCR 2010
♦ Permanent lead in S3: 105 patients♦ Permanent lead in S4: 21 patients♦ Explantation: 15 out of 126 (12%)
● Decrease function: 11● Infection: 2● Technical failure: 1
♦ Explantation: Median time 357 (24-1238) days
SNS Six Year Follow-UpThe Danish Experience
Michelsen et al. DCR 2010
Median Wexner incontinence score through the follow-up period
p< 0.001 for 3 and 6 months, and 1, 2, 3, 4 and 6 years. p<0.001 for 5 years
SNS Long-term results10 years Follow-up
Matzel et al. Colorectal Dis 2009
♦ 1994 - 1999♦ 9 patients♦ Mean follow-up 9.8 (7-14) years♦ Median number of incontinent episodes/week: 9 to 0♦ Median Wexner score: 17 to 10♦ Quality of life improved in all categories♦ Pulse generator exchange was required in 8/9 at mean of 7.4 yrs♦ Complications: 4/12 (33%)
● Pain (2)● Displacement (1)● Urinary retention (1)
SNS and Sphincter DefectSystematic Review
Ratto et al. Colorectal Dis 2012
♦ 10 studies (119 patients) met inclusion criteria● 9 retrospective● 1 prospective
♦ Definitive implant in 106 patients (89%)
♦ Follow-up: 22.9 (4.5-46) months
SNS and Sphincter DefectSystematic Review
Ratto et al. Colorectal Dis 2012
Significant findings:
♦ Wexner Fecal Incontinence Score: 16.5 to 3.8
♦ Incontinent episodes per week: 12.1 to 2.3
♦ Ability to defer defecation
♦ Fecal Incontinence Quality of life Scale
♦ No change in anorectal manometry
SNS for fecal incontinence associated with other specific conditions
IndicationAuthor/
YearPatients
(n)
Improved Outcomes(Wexner FI, Number
incontinent episodes, QOL)
Rectal Resection Holtzer 2008 7 71%
Rectal Resection De Miguel 2010 7 100%
Rectal prolapse surgery RobertYap 2010 11 100%
Pelvic floor injury Oom 2010 29 86%
Radiation Maeda 2010 7 83%
Spinal cord injury Lombardi 2010 37 59%
SNS - Technique
VIDEOS
What’s Next for Patients?
Consider InterStim Therapy to those patients who aren’t responding favorably to medical therapy.
Overview of Trial Assessment
● Through a minimally invasive procedure initiated in the office or in an outpatient hospital setting, a lead (thin wire) is placed near the sacral nerve (target S3)
● The lead is connected to an external test stimulator worn on the patient’s waistband for several days.
● The patient will be asked to record bowel behavior during the trial
● If patient experiences success, a neurostimulator may be implanted
● If patient does not experience success, a subsequent trial assessment may be recommended
● If patient still does not experience success, the lead will be removed and the patient will immediately be able to try other options
ImplanterReferring Physician ImplanterReferring PhysicianReferring Physician
CollaborativeProcess toOptimize
Patient Care
Initial Diagnosis
Initial Diagnosis
Conservative Treatments
Conservative Treatments
ReferralReferral
InterStimImplant
InterStimImplant
Device-related Follow-up
Ongoing General Patient Care
Ongoing General Patient Care
InterStimTrial Assessment
InterStimTrial Assessment
Benefits of Referring Your Patients
● Practical and extensive experience with InterStim Therapy
● Offering your patients a minimally invasive option that can restore function1
● We will collaborate to develop a follow-up plan once symptoms are successfully treated
What Should You Tell Your Patients?
♦ “I would like to refer you to a specialist who will evaluate your condition further and determine if InterStim Therapy might be an option for you”
♦ “The InterStim trial assessment will give you a chance to find out during a short trial period if long-term therapy may be a good option for you”
♦ “InterStim Therapy is an established therapy that is FDA approved for chronic fecal incontinence patients who have not benefited from conventional therapies”
Summary ♦ Fecal incontinence (FI) is very common and may impact a person’s quality of life
♦ Patients may be embarrassed to discuss FI symptoms and are often unaware of the new treatment options available
♦ If conservative treatments have been unsuccessful, refer patients to my practice to determine if InterStim Therapy is an option for them
♦ By partnering, you can expand patients’ treatment options and help find the best solution to manage their symptoms
♦ Together we can improve the quality of life for patients with bowel control problems
Cutting Edge Colorectal Surgery
♦ TEM (Transanal Endoscopic Microsurgery)
♦ Total Laparoscopic Surgery
♦ Robotic Surgery
♦ Gracilis flap for recto-vaginal/recto-urethral fistulas
TEM (Transanal Endoscopic Microsurgery)
Rectal Cancer: Treatment Options
TEM Local Excision
Removal some node bearing tissue
Disc excision of the
rectal wall
Lower recurrence rates (2-
10%)
Higher recurrence rates (up to 25%)
Better staging ? Staging
TEMJust another local excision?
• What’s so special?
Optimal visualization
3D Image
Balanced insufflation
Access to mid and upper rectum
Potential for lymphadenectomy
Total Laparoscopic Surgery
Total Laparoscopic Surgery
♦ Decrease in wound size
♦ Reduction in wound infection, dehiscence, bleeding, herniation and nerve entrapment
♦ Decrease in wound pain
♦ Improved mobility
Robotic Surgery
How Has Colorectal Surgery Evolved?
da Vinci®
Surgery
How Does My Robotic Surgery Room Look?
da Vinci Low Anterior Resection - Rectal Cancer
Gracilis flap for recto-vaginal/recto-urethral fistulas
1. Patient’s position 2. Distal medial thigh incision
3. Two thigh incisions 4. Muscle mobilization5. Neuro-vascular pedicle identification
Gracilis flap for recto-vaginal/recto-urethral fistulas
Gracilis flap for recto-vaginal/recto-urethral fistulas
♦ A viable option for repairing RVF and RUF,
especially after failed perineal or transanal repair
♦ It is associated with low morbidity and good success
rate