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
• Interventions: Device: Biodesign Tissue Repair Graft; Other: Overlapping Sphincter Repair

• 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

Arm && Interventions

Group	Intervention	Description
Biodesign Tissue Repair Graft	Overlapping Sphincter Repair	Biodesign Tissue Repair Graft
Biodesign Tissue Repair Graft	Biodesign Tissue Repair Graft	Biodesign Tissue Repair Graft
Overlapping Sphincter Repair	Overlapping Sphincter Repair	Control

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