NCT00450671

Treatment of Perirectal Fistula With Cutting Seton vs. Collagen Plug

Seton Placement vs. Surgisis Anal Fistula Plug Insertion for Perirectal Fistula: A Prospective Randomized Study

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: University of Southern California · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine if the collagen plug method heals perirectal fistulae as well as the conventional seton method.

Detailed description

Traditional treatments for transsphincteric perirectal fistulae rely upon an immediate (fistulotomy) or delayed (seton) transsection of the sphincter muscle possibly resulting in fecal incontinence, take a long time to heal, and/or are associated with significant failure rates (ex. fibrin glue). Newer treatment concepts such as the collagen plug do not physically interrupt the sphincter muscle, avoid and minimize the risk of fecal incontinence, and decrease the time to fistula healing. Exciting initial reports have confirmed the collagen plug's utility in treating perirectal fistulae, but a systematic scientific comparison is needed to validate the new, less invasive plug method. The primary goal of this study is to show that the collagen plug heals transsphincteric perirectal fistulae as well as the conventional seton method.

Conditions

• Anal Fistula

Interventions

Type	Name	Description
PROCEDURE	Collagen Plug Placement
PROCEDURE	Seton placement

Timeline

• Start date: 2007-02-01
• Completion: 2013-05-09
• First posted: 2007-03-22
• Last updated: 2017-03-17

Locations

4 sites across 1 country: United States