Seton Placement vs. Surgisis Anal Fistula Plug Insertion for Perirectal Fistula: A Prospective Randomized Study
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.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Andreas M Kaiser, MD
University of Southern California Department of Colorectal Surgery
United States: Institutional Review Board
Seton vs. Surgisis
|USC Norris Cancer Center||Los Angeles, California 90033|
|Los Angeles County-USC Medical Center||Los Angeles, California 90033|
|USC/University Hospital||Los Angeles, California 90033|
|H.Claude Hudson Comprehensive Health Center||Los Angeles, California 90007|