Comparison of the Efficacy of a Biological Implant to Reinforce Overlapping Sphincter Repair Versus Overlapping Sphincter Repair Alone
Primary Purpose
Fecal Incontinence, Anal Incontinence
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Biodesign Tissue Repair Graft
Overlapping Sphincter Repair
Sponsored by
About this trial
This is an interventional treatment trial for Fecal Incontinence
Eligibility Criteria
Inclusion Criteria:
- Female
- Age 18 years or older
- fecal incontinence due to an anterior defect in the external anal sphincter or both external and internal anal sphincter muscles
- Fecal incontinence severity score of 10 or more
- Fecal incontinence episodes of 4 or more over a 2 week period
Exclusion Criteria:
- History of diabetes
- History of allergy to porcine derivatives
- History of infection in the anal area (abscess, fistula)
- History of inflammatory bowel disease
- History of hidradenitis suppurativa
- History of immunosuppression
- History of HIV positivity
- History of radiation to the study site within the last 12 months
- Patients who cannot travel to keep follow up appointments
- Patients who are prisoners
- Patients who are mentally handicapped
- Patients who are pregnant or plan to become pregnant during the study period, or who are currently breastfeeding
- Patients with significant posterior pelvic organ prolapse and who would be candidates for concomitant treatment.
- Patients with a FIQL baseline score of ≤ 4
- Patients participating in another clinical trial for the same indication
- Patients unwilling to give informed consent
Sites / Locations
- Cleveland Clinic Foundation
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Biodesign Tissue Repair Graft
Overlapping Sphincter Repair
Arm Description
Biodesign Tissue Repair Graft
Control
Outcomes
Primary Outcome Measures
Number of Participants Reporting a Decrease in Incontinence Episodes Per Week
Secondary Outcome Measures
Number of Participants Reporting a Decrease in Incontinence Episodes Per Week
Full Information
NCT ID
NCT01044589
First Posted
January 7, 2010
Last Updated
July 5, 2017
Sponsor
Massarat Zutshi
Collaborators
Cook Group Incorporated
1. Study Identification
Unique Protocol Identification Number
NCT01044589
Brief Title
Comparison of the Efficacy of a Biological Implant to Reinforce Overlapping Sphincter Repair Versus Overlapping Sphincter Repair Alone
Official Title
Comparison of the Efficacy of a Biological Implant to Reinforce Overlapping Sphincter Repair Versus Overlapping Sphincter Repair Alone
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Terminated
Why Stopped
The study was stopped due to low enrollment
Study Start Date
May 2010 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Massarat Zutshi
Collaborators
Cook Group Incorporated
4. Oversight
5. Study Description
Brief Summary
The aim of this study is to compare the efficacy of Biodesign™ Surgisis® Tissue Graft to reinforce an overlapping sphincter repair versus the standard overlapping sphincter repair in controlling episodes of incontinence in patients who have fecal incontinence and a defect in the anal sphincter.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fecal Incontinence, Anal Incontinence
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Biodesign Tissue Repair Graft
Arm Type
Experimental
Arm Description
Biodesign Tissue Repair Graft
Arm Title
Overlapping Sphincter Repair
Arm Type
Active Comparator
Arm Description
Control
Intervention Type
Device
Intervention Name(s)
Biodesign Tissue Repair Graft
Intervention Description
Biodesign Tissue Repair Graft reinforcement
Intervention Type
Other
Intervention Name(s)
Overlapping Sphincter Repair
Intervention Description
Overlapping Sphincter Repair Alone
Primary Outcome Measure Information:
Title
Number of Participants Reporting a Decrease in Incontinence Episodes Per Week
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Number of Participants Reporting a Decrease in Incontinence Episodes Per Week
Time Frame
24 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Female
Age 18 years or older
fecal incontinence due to an anterior defect in the external anal sphincter or both external and internal anal sphincter muscles
Fecal incontinence severity score of 10 or more
Fecal incontinence episodes of 4 or more over a 2 week period
Exclusion Criteria:
History of diabetes
History of allergy to porcine derivatives
History of infection in the anal area (abscess, fistula)
History of inflammatory bowel disease
History of hidradenitis suppurativa
History of immunosuppression
History of HIV positivity
History of radiation to the study site within the last 12 months
Patients who cannot travel to keep follow up appointments
Patients who are prisoners
Patients who are mentally handicapped
Patients who are pregnant or plan to become pregnant during the study period, or who are currently breastfeeding
Patients with significant posterior pelvic organ prolapse and who would be candidates for concomitant treatment.
Patients with a FIQL baseline score of ≤ 4
Patients participating in another clinical trial for the same indication
Patients unwilling to give informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Massarat Zutshi, MD
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Comparison of the Efficacy of a Biological Implant to Reinforce Overlapping Sphincter Repair Versus Overlapping Sphincter Repair Alone
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