Comparison of the Efficacy of a Biological Implant to Reinforce Overlapping Sphincter Repair Versus Overlapping Sphincter Repair Alone

Not Applicable

Terminated

• Conditions: Fecal Incontinence; Anal Incontinence

• Registration Number: NCT01044589
• Lead Sponsor: Massarat Zutshi

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-01-07
• Study First Submitted QC: 2010-01-07
• Study First Posted: 2010-01-08
• Study Start: 2010-05
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Results First Submitted: 2017-04-18
• Status Verified: 2017-07
• Results First Submitted QC: 2017-07-05
• Last Update Submitted: 2017-07-05
• Results First Posted: 2017-08-01
• Last Update Posted: 2017-08-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 13

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Number of Participants Reporting a Decrease in Incontinence Episodes Per Week	12 months

Secondary Outcome Measures

Name	Time	Method
Number of Participants Reporting a Decrease in Incontinence Episodes Per Week	24 months

Trial Locations

Locations (1)

Cleveland Clinic Foundation; 🇺🇸 Cleveland, Ohio, United States