Treatment of Perirectal Fistula With Cutting Seton vs. Collagen Plug

Study Overview
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Brief Summary
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The purpose of this study is to determine if the collagen plug method heals perirectal fistulae as well as the conventional seton method.

Detailed Description
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Traditional treatments for transsphincteric perirectal fistulae rely upon an immediate (fistulotomy) or delayed (seton) transsection of the sphincter muscle possibly resulting in fecal incontinence, take a long time to heal, and/or are associated with significant failure rates (ex. fibrin glue). Newer treatment concepts such as the collagen plug do not physically interrupt the sphincter muscle, avoid and minimize the risk of fecal incontinence, and decrease the time to fistula healing. Exciting initial reports have confirmed the collagen plug's utility in treating perirectal fistulae, but a systematic scientific comparison is needed to validate the new, less invasive plug method. The primary goal of this study is to show that the collagen plug heals transsphincteric perirectal fistulae as well as the conventional seton method.

Official Title
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Seton Placement vs. Surgisis Anal Fistula Plug Insertion for Perirectal Fistula: A Prospective Randomized Study

Conditions
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Anal Fistula

Intervention / Treatment
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* Procedure: Collagen Plug Placement
* Procedure: Seton placement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients that are undergoing surgery for perirectal fistulae by the USC Colorectal Group Patients that are older than 18 years of age and are able to understand and sign consent Patients that are suitable candidates for either seton or collagen plug placement Exclusion Criteria: Preoperative patient exclusion factors: Pregnant patients Patients with a tumor-related fistula Patients with known allergies to porcine products Patients with known Crohn's disease Intraoperative patient exclusion factors: Patients with an active purulent infection (pus draining from the fistula tract or abscess associated with the fistula tract) at the time of surgery Patients with a large diameter fistula (>3mm) Patients with a superficial fistula Patients with a short fistula (<1 cm in length)

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

| Intervention/Treatment |
| --- |
|Procedure: Collagen Plug Placement|nan|
|Procedure: Seton placement|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fistula healing |  |  | 
| Treatment failure |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to fistula healing |  |  | 
| Time to treatment failure |  |  | 
| Rates of postoperative fecal continence |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fistula-in-ano, Anal fistula, Perirectal fistula, Collagen plug, Surgisis, Seton