NCT00830661UnknownNot Applicable
A Randomized, Prospective, Multi-Centered Study Comparing Clinical Outcomes of the Ligation of Intersphincteric Fistula Tract (LIFT)Procedure Versus Use of Anal Fistula Plug (AFP)in the Surgical Repair of Trans-Sphincteric Anal Fistulae of Cryptoglandular Origin
Colon and Rectal Surgery Associates, Ltd.8 sites in 2 countries124 target enrollmentStarted: March 1, 2009Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 124
- Locations
- 8
- Primary Endpoint
- The 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
Study Overview
Brief Summary
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Male or female subjects 18 years of age or older.
- •Able to understand and provide informed consent or have a legally authorized representative capable of providing consent.
- •Has a documented diagnosis, confirmed by physical exam and/or endorectal ultrasound (if available), of a trans-sphincteric fistula tract determined to be of cryptoglandular origin (primary or recurrent).
Exclusion Criteria
- •History or suspicion of Inflammatory Bowel Disease (Crohn's or Ulcerative colitis).
- •History of connective tissue disease.
- •Rectovaginal fistula.
- •Presence of horseshoe fistula.
- •History of immunosuppression therapy/treatment within previous six months.
- •Presents of a proximal diversion and refractory fistula.
- •Any physical conditions, disease, or disorder that would exclude subject from being a candidate for elective surgery.
- •Known history of allergy to pork or pork products.
Outcomes
Primary Outcomes
The 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 Outcomes
- Secondary measures will include level of fecal incontinence, fecal incontinence quality of life, complication rates, and rate of closure after re-operation(1 month, 3 month, 6 month, 12 months postoperatively)
Investigators
Study Sites (8)
Loading locations...
Similar Trials
Unknown
Phase 2
Therapeutic Management of Complex Anal Fistulas by Installing a Closure Clip: Multicentre Randomized Controlled TrialComplex Anal FistulaNCT02336867University Hospital, Clermont-Ferrand92
Unknown
Not Applicable
Effectiveness of Anal Enlargement by Dilators as a Therapeutic Physical Tool in Acute Anal FissureAcute Anal FissureNCT04828889Sheba Medical Center75
Unknown
Not Applicable
Surgical Treatment of a Chronic Anal FissureChronic Anal FissureNCT05117697State Scientific Centre of Coloproctology, Russian Federation120
Terminated
Not Applicable
Anal Fistula Plug for High-type Anal FistulaeHigh-type Anal FistulaeNCT00487071Chinese University of Hong Kong10
Withdrawn
Phase 4
Anal Fistula Repair With Platelet-rich PlasmaRectal FistulaNCT02678936University Hospital, Basel, Switzerland