Ligation of the Intersphincteric Fistula Tract (LIFT) + Biodesign for Anal Fistula
Completed
- Conditions
- Anal Fistula
- Registration Number
- NCT01602081
- Lead Sponsor
- Cook Group Incorporated
- Brief Summary
The LIFT+Biodesign® study is a post-market observational study to evaluate the rate of fistula closure in patients with persistent trans-sphincteric anal fistula who receive the Biodesign® Tissue graft as part of their LIFT procedure.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 28
Inclusion Criteria
- Persistent primary or recurrent trans-sphincteric anal fistula
Exclusion Criteria
- Patients with prior fistulotomy, fistulectomy, LIFT, cutting seton or advancement flap procedure
- Fistula with multiple tracts
- Recto-vaginal fistula
- Active infection in the anal fistula
- Physical allergies or cultural objections to porcine products
- Patient is not medically fit to undergo the LIFT procedure as judged by the treating physician
- Previous diagnosis of collagen disorder
- History of Crohn's Disease, Irritable Bowel Syndrome, radiation therapy in the rectoanal region
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Closure of the anal fistula 6 months
- Secondary Outcome Measures
Name Time Method Closure of the anal fistula 12 months
Trial Locations
- Locations (8)
University of California Irvine
🇺🇸Orange, California, United States
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
Indiana University Hospitals
🇺🇸Indianapolis, Indiana, United States
Kendrick Regional Center
🇺🇸Indianapolis, Indiana, United States
Ochsner Clinic Foundation
🇺🇸New Orleans, Louisiana, United States
Mount Sinai Hospital
🇺🇸New York, New York, United States
Case Medical Center
🇺🇸Cleveland, Ohio, United States
Hospital of the University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
University of California Irvine🇺🇸Orange, California, United States