LIFT-plug vs LIFT, a RCT Trial

Study Overview
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Brief Summary
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To validate the effect of Ligation of Intersphincteric Fistula Tract (LIFT) Versus LIFT-plug procedure for Anal Fistula Repair in 7 medical centers

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 in 7 medical centers.

Official Title
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Ligation of Intersphincteric Fistula Tract Versus Ligation of the Intersphincteric Fistula Tract Plus a Bioprosthetic Anal Fistula Plug Procedure in Patients With Transsphincteric Anal Fistula: Multicenter Prospective Randomized Trial

Conditions
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Anal Fistula, LIFT-plug, Healing Rate, Anal Function

Intervention / Treatment
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* Procedure: LIFT-plug technique


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: High transsphincteric fistula (involving > 30% of the external anal sphincter) Age between 18 and 70 years Chronic anal fistula with fistula tracts no more than 2 No active sepsis or abscess Exclusion Criteria: Fistulas with active inflammation or purulence Fistulas related to tumor, Crohn's disease, tuberculosis or acquired immune deficiency syndrome Poorly controlled diabetes with fasting blood-glucose > 8mmol/L Preexisting incontinence Multiple fistula tracts > 2 Fasting blood-glucose ≥ 8mmol/L Allergic or contraindication for the use of animal protein Pregnant women Expected life less than 6 months With anorectal abscess Serious liver (Child-Pugh C) and chronic kidney disease (CKD) stage 3

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LIFT-plug<br>The LIFT-plug procedure was performed as followings. A portion of the fistula tract was excised from ei¬ther end within the intersphincteric space. One porcine small-intestine submucosa extracellular matrix plug was soaked in saline for 5-10 min, then placed into the intersphincteric groove and pulled through the curetted tract to the external opening. The plug was secured with a figure-of-eight 3/0 absorbable suture to the fistula opening in the external sphincter and ligated. Excess plug protruding from the external opening was trimmed flush with the skin without fixation. The wound was loosely closed with 2-3 interrupted 3/0 absorbable sutures. | Procedure: LIFT-plug technique<br>* Small-intestine submucosa extracellular matrix plug was soaked in saline for 5-10 min, then placed into the intersphincteric groove and pulled through the curetted tract to the external opening. The plug was secured with a figure-of-eight 3/0 absorbable suture to the fistula opening in the external sphincter and ligated. Excess plug protruding from the external opening was trimmed flush with the skin without fixation. The wound was loosely closed with 2-3 interrupted 3/0 absorbable sutures<br>|
| Experimental: LIFT<br>The LIFT procedure was performe as followings. The curvilinear incision and dissection of the intersphincteric tract were made as in the LIFT-plug technique. After the tract was isolated, the tract was doubly-ligated and suture-ligated with absorbable sutures as close as possible to the lateral margin of the internal anal sphincter and the medial margin of the external anal sphincter. The tract was then divided between the two sutures. A portion of the fistula tract was excised after ligation of ei¬ther end within the intersphincteric space. The medial ligature was very close to the internal opening, and nearly obliterated the internal opening. The external opening was then enlarged to allow adequate drainage. The internal and external sphincters were then re-approximated, and the skin was closed loosely with interrupted 3/0 absorbable suture. | Procedure: LIFT-plug technique<br>* Small-intestine submucosa extracellular matrix plug was soaked in saline for 5-10 min, then placed into the intersphincteric groove and pulled through the curetted tract to the external opening. The plug was secured with a figure-of-eight 3/0 absorbable suture to the fistula opening in the external sphincter and ligated. Excess plug protruding from the external opening was trimmed flush with the skin without fixation. The wound was loosely closed with 2-3 interrupted 3/0 absorbable sutures<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Healing rate | the healing rate of two groups in 6 months postoperatively | 6 months postoperatively | 
| healing time | the wound healing time from operation to healing | 6 months postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| anal function | wexner score | 5 days, 2 weeks, 1 months, 3 months and 1 year postoperatively | 
| pain score postoperatively | visual analog scale scores | 5 days, 2 weeks, 1 months, 3 months and 1 year postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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anorectal fistula, LIFT-plug, complications of treatment, healing rate, anal function