Ligation of Intersphincteric Fistula Tract (LIFT) Procedure Versus Use of an Anal Fistula Plug for Anal Fistula Repair

Not Applicable

• Conditions: Anal Fistula
• Interventions: Procedure: Ligation of intersphincteric fistula track procedure; Procedure: anal fistula plug

• Registration Number: NCT00830661
• Lead Sponsor: Colon and Rectal Surgery Associates, Ltd.

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-01-27
• Study First Submitted QC: 2009-01-27
• Study First Posted: 2009-01-28
• Study Start: 2009-03
• Status Verified: 2009-05
• Last Update Submitted: 2009-05-28
• Last Update Posted: 2009-05-29
• Primary Completion: 2012-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 124

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LIFT	Ligation of intersphincteric fistula track procedure	those subjects receiving the Ligation of Intersphincteric Fistula Track procedure
Plug	anal fistula plug	those subjects randomized to the receive the placement of the porcine anal fistula plug

Primary Outcome Measures

Name	Time	Method
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	1month, 3 month, 6 month, 12 month postoperatively

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (4)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

Colon and Rectal Surgery Associates, Ltd; 🇺🇸 Minneapolis, Minnesota, United States

University of Pennsylvania Health System; 🇺🇸 Philadelphia, Pennsylvania, United States

University of Ottawa; 🇨🇦 Ottawa, Ontario, Canada