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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
124
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.
placement of the porcine anal fistula plug as per the instructions for use in product packaging
Massachusetts General Hospital
Boston, Massachusetts, United States
NOT_YET_RECRUITINGColon and Rectal Surgery Associates, Ltd
Minneapolis, Minnesota, United States
RECRUITINGUniversity of Pennsylvania Health System
Philadelphia, Pennsylvania, United States
RECRUITINGThe primary outcome measure of this study will be to compare the rate of fistula closure between the ligation of the intersphincteric fistula track (LIFT) procedure and the use of a porcine bioabsorbable anal fistula plug
Time frame: 1month, 3 month, 6 month, 12 month postoperatively
Secondary measures will include level of fecal incontinence, fecal incontinence quality of life, complication rates, and rate of closure after re-operation
Time frame: 1 month, 3 month, 6 month, 12 months postoperatively
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University of Ottawa
Ottawa, Ontario, Canada
NOT_YET_RECRUITING