The purpose of this study is to determine if the collagen plug method heals perirectal fistulae as well as the conventional seton method.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
300
H.Claude Hudson Comprehensive Health Center
Los Angeles, California, United States
Los Angeles County-USC Medical Center
Los Angeles, California, United States
USC Norris Cancer Center
Los Angeles, California, United States
USC/University Hospital
Los Angeles, California, United States
Fistula healing
Treatment failure
Time to fistula healing
Time to treatment failure
Rates of postoperative fecal continence
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.