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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
Massarat Zutshi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fecal Incontinence

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

First Posted
January 7, 2010
Last Updated
July 5, 2017
Sponsor
Massarat Zutshi
Collaborators
Cook Group Incorporated
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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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