Ligation of Intersphincteric Fistula Tract (LIFT) Versus LIFT-plug Procedure for Anal Fistula Repair

Study Overview
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Brief Summary
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The purpose of this study is to validate the effect of Ligation of Intersphincteric Fistula Tract (LIFT) Versus LIFT-plug procedure for Anal Fistula Repair.

Detailed Description
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The management of trans-sphincteric anal fistulae of cryptoglandular origin is challenging. The ideal management is to effectively heal the fistula without compromising continence, avoid fistula recurrence, and quick recovery. Ligation of the intersphincteric fistula tract (LIFT) and LIFT reinforced with a bioprosthetic graft (BioLIFT) are two recently reported procedures that showed improved healing results. In the LIFT, Rojanasakul et al proposed to identify the fistula tract in the intersphincteric space and subsequent division and ligation of the tract, and the primary healing rate was 94.4%. The following studies reported slightly lower results, but the recurrence rate was as high as 18% to 28%. Ellis et al subsequently described a modified LIFT procedure (BioLIFT procedure) in which a bioprosthetic was placed in the intersphincteric plane to reinforce the closure of the fistula tract (BioLIFT procedure), and yielded a healing rate of 94% in 31 patients who had a minimum of 1 year of follow-up after their last treatment. The investigators modified the LIFT procedure by combining LIFT with the technique of anal fistula plug. The bioprosthetic plug was placed into the fistula tract through the opening in the external sphincter to the external opening in the skin after LIFT procedure. The present study was designed to assess the preliminary results of LIFT-Plug technique prospectively. The purpose of this study is to validate the effect of Ligation of Intersphincteric Fistula Tract (LIFT) Versus LIFT-plug procedure for Anal Fistula Repair.

Official Title
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Ligation of Intersphincteric Fistula Tract (LIFT) Versus LIFT-plug Procedure for Anal Fistula Repair: a Multicenter, Randomized, Open-label, Parallel Controlled Trial

Conditions
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Anorectal Fistula, Extracellular Matrix Alteration

Intervention / Treatment
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* Procedure: LIFT-plug
* Procedure: LIFT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female subjects over eighteen years old or less than 65 years old. Able to understand and provide informed consent or have a legally authorized representative capable of providing consent. Clinical diagnosis of primary anal fistula categorized as trans-sphincteric fistula tract determined to be of cryptoglandular origin (primary or recurrent). Exclusion Criteria: Presence of horseshoe fistula. History of immunosuppression therapy/treatment within previous six months. Fistulas with active abscess, infection, or acute inflammation History of Choron's Disease History of Ulcerative Colitis History of HIV or other immune system disease History of collagen disease History of radiation to the anorectal region Allergies to pig tissue or pig products Religious or cultural objection to the use of pig tissue

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- |
| Experimental: LIFT<br>Subjects randomized to this arm will receive the ligation of the intersphincteric fistula track (LIFT) procedure | Procedure: LIFT<br>* Subjects randomized to this arm will receive the ligation of the intersphincteric fistula track (LIFT) procedure<br>|
| Experimental: LIFT-plug<br>Subjects randomized to this arm will receive the ligation of the intersphincteric fistula track and plug (LIFT-plug) procedure | Procedure: LIFT-plug<br>* Subjects randomized to this arm will receive the ligation of the intersphincteric fistula track and plug (LIFT-plug) procedure<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Healing time |  | 1month, 3 month, 6 month postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| recurrence rate |  | 1month, 3 month, 6 month postoperatively | 
| postoperative pain | The methodology used for the evaluation of postoperative perineal pain severity and relief, is the visual analogue scale (VAS) (1-10). We considered positive a VAS > 4. | 1month, 3 month, 6 month postoperatively | 
| fecal incontinence |  | 1month, 3 month, 6 month postoperatively | 
| complication rates |  | 1month, 3 month, 6 month postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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anorectal fistula, acellular dermal matrix, ligation of intersphincteric fistula tract, ligation of intersphincteric fistula tract and plug, complications of treatment, recurrence