Treatment of Perirectal Fistula With Cutting Seton vs. Collagen Plug

Status Completed

Clinical Trial Summary

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

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00450671
Study type	Interventional
Source	University of Southern California
Contact
Status	Completed
Phase	Phase 3
Start date	February 2007
Completion date	May 9, 2013

View Details

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