NCT01044589
Terminated
Not Applicable
Comparison of the Efficacy of a Biological Implant to Reinforce Overlapping Sphincter Repair Versus Overlapping Sphincter Repair Alone
Massarat Zutshi1 site in 1 country13 target enrollmentMay 2010
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Fecal Incontinence
- Sponsor
- Massarat Zutshi
- Enrollment
- 13
- Locations
- 1
- Primary Endpoint
- Number of Participants Reporting a Decrease in Incontinence Episodes Per Week
- Status
- Terminated
- Last Updated
- 8 years ago
Overview
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.
Investigators
Massarat Zutshi
Staff
The Cleveland Clinic
Eligibility Criteria
Inclusion Criteria
- •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
Outcomes
Primary Outcomes
Number of Participants Reporting a Decrease in Incontinence Episodes Per Week
Time Frame: 12 months
Secondary Outcomes
- Number of Participants Reporting a Decrease in Incontinence Episodes Per Week(24 months)
Study Sites (1)
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