A Prospective Evaluation of the Strattice-LIFT to Treat Anal Fistula

Study Overview
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Brief Summary
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This clinical trial will evaluate the safety and efficacy of the Strattice-LIFT procedure to treat anal fistulas.

Detailed Description
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The treatment of anal fistulas remains a challenging clinical problem. Fistulotomy is highly effective, but carries a significant risk of postoperative incontinence. A variety of surgical procedures that do not divide the sphincter muscle may be offered to patients, however none of them are as effective as fistulotomy. The LIFT (ligation of intersphincteric fistula tract) procedure is a newer option for the treatment of transsphincteric fistulas. Initial results have been promising. However, some fistulas recur after the LIFT procedure because the divided ends of the fistula tract recanalize. Insertion of a barrier into the intersphincteric space may prevent this process. Strattice is acellular porcine dermis, will be used for this purpose. This prospective trial will evaluate the safety and efficacy of the Strattice-LIFT procedure for the treatment of transsphincteric anal fistulas.

Official Title
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A Prospective Evaluation of the Strattice-LIFT to Treat Anal Fistula

Conditions
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Anal Fistula, Rectal Fistula, Fistula in Ano, Transsphincteric Fistula

Intervention / Treatment
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* Device: Strattice-LIFT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is 22 years of age or older Subject is willing to comply with study related procedures Subject is not pregnant Subject has a transsphincteric fistula Subject is medically fit to undergo LIFT Subject has a draining seton for a minimum of 6 weeks Exclusion Criteria: Crohn's disease Pelvic radiation treatment Known or suspected HIV/AIDS Known sensitivity to pork products Abscess or fistula etiology other than cryptoglandular Abdominal malignancies Patients with <1 year life expectancy History of smoking Known anorectal dysfunction (fecal incontinence) Chronic use of steroids or other agents which may affect wound healing ASA ≥ 2 Unable to consent to study Unable to complete 1 year follow up

Ages Eligible for Study
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Minimum Age: 22 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Strattice-LIFT<br> | Device: Strattice-LIFT<br>* Patients undergoing surgery for transsphincteric anal fistulas will undergo the Strattice-LIFT procedure. A standard LIFT procedure will be performed with the addition of Strattice placed into the intersphincteric space.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Healing of the anal fistula | Healing is defined as the combination of patient reported lack of drainage and surgeon reported closure of the external opening | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Healing of the anal fistula | Healing is defined as the combination of patient reported lack of drainage and surgeon reported closure of the external opening | 1 year | 
| Postoperative Pain | Postoperative pain will be assessed at each postoperative visit with a visual analog scale | 1 year | 
| Complications | Postoperative complications such as infection/abscess, bleeding, urinary retention, new fistula, constipation, or fecal incontinence | 1 year |