Ligation of the Intersphincteric Fistula Tract With Tissue Graft Placement for Treatment of Persistent Trans-sphincteric Anal Fistula
Description
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.
Phase
N/AInclusion and Exclusion Criteria
- Persistent primary or recurrent trans-sphincteric anal fistula
- 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
Sites
-
California
- University of California Irvine, Orange, California, 92868
-
Louisiana
- Ochsner Clinic Foundation, New Orleans, Louisiana, 70121
-
Indiana
- Indiana University Hospitals, Indianapolis, Indiana, 46202
- Kendrick Regional Center, Indianapolis, Indiana, 46237
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