NCT00830661

Ligation of Intersphincteric Fistula Tract (LIFT) Procedure Versus Use of an Anal Fistula Plug for Anal Fistula Repair

A Randomized, Prospective, Multi-Centered Study Comparing Clinical Outcomes of the Ligation of Intersphincteric Fistula Tract (LIFT)Procedure Versus Use of Anal Fistula Plug (AFP)in the Surgical Repair of Trans-Sphincteric Anal Fistulae of Cryptoglandular Origin

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 124 (estimated)
• Sponsor: Colon and Rectal Surgery Associates, Ltd. · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Anal fistulae are a difficult problem to treat. The optimal treatment for fistula involving the anal sphincter is unclear. Two standardly used methods of treatment are the ligation of intersphincteric fistula track (LIFT) procedure and the use of an anal fistula plug. The purpose of this study is to exam the rate of fistula closure between the LIFT procedure and the use of a fistula plug

Conditions

• Anal Fistula

Interventions

Type	Name	Description
PROCEDURE	Ligation of intersphincteric fistula track procedure	Subjects randomized to this arm will receive the ligation of the intersphincteric fistula track (LIFT) procedure. This procedure will be performed as per standard operating procedure.
PROCEDURE	anal fistula plug	placement of the porcine anal fistula plug as per the instructions for use in product packaging

Timeline

• Start date: 2009-03-01
• Primary completion: 2012-03-01
• First posted: 2009-01-28
• Last updated: 2009-05-29

Locations

4 sites across 2 countries: United States, Canada