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

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Anal Fistula

Intervention / Treatment
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* Procedure: Ligation of intersphincteric fistula track procedure
* Procedure: anal fistula plug


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: LIFT<br>those subjects receiving the Ligation of Intersphincteric Fistula Track procedure | Procedure: Ligation of intersphincteric fistula track procedure<br>* 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.<br>|
| Active Comparator: Plug<br>those subjects randomized to the receive the placement of the porcine anal fistula plug | Procedure: anal fistula plug<br>* placement of the porcine anal fistula plug as per the instructions for use in product packaging<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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transsphincteric anal fistula, cryptoglandular origin, anal fistula repair, Ligation of Intersphincteric Fistula Track (LIFT) procedure, anal fistula plug (Plug), surgical repair