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

NCT01044589 | Terminated Results

• 1 other identifier: 09-008
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Fecal Incontinence; Anal Incontinence

Outcome Measures

Primary Outcomes (1)

• Number of Participants Reporting a Decrease in Incontinence Episodes Per Week

  12 months

Secondary Outcomes (1)

• Number of Participants Reporting a Decrease in Incontinence Episodes Per Week

  24 months

Study Arms (2)

Biodesign Tissue Repair Graft

EXPERIMENTAL

Biodesign Tissue Repair Graft

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

Overlapping Sphincter Repair

ACTIVE COMPARATOR

Control

Other: Overlapping Sphincter Repair

Interventions

Biodesign Tissue Repair Graft DEVICE

Biodesign Tissue Repair Graft reinforcement

Biodesign Tissue Repair Graft

Overlapping Sphincter Repair OTHER

Overlapping Sphincter Repair Alone

Biodesign Tissue Repair Graft; Overlapping Sphincter Repair

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Massarat Zutshi: lead
• Cook Group Incorporated: collaborator

Study Sites (1)

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Fecal Incontinence; Encopresis

Condition Hierarchy (Ancestors)

Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior; Elimination Disorders; Mental Disorders

Results Point of Contact

• Title: Dr. Massarat Zutshi
• Organization: Cleveland Clinic

zutshim@ccf.org

(216) 444-3540

Study Officials

• Massarat Zutshi, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Staff

Study Record Dates

• First Submitted: January 7, 2010
• First Posted: January 8, 2010
• Study Start: May 1, 2010
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: August 1, 2017
• Results First Posted: August 1, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)