Seton or Glue for Trans-sphincteric Anal Fistulas

Study Overview
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Brief Summary
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Surgical treatment of perianal fistulas frequently affects fecal continence. Sphincter saving techniques like loose or cutting seton and fistulectomy with advancement of an endorectal flap have been advocated to minimize the risk of sphincter injury, but patients often complain of a prolonged healing period and major discomfort. Furthermore, the healing rate varies widely according to the type of fistula and the surgeon's experience.In the early '90s the treatment of perianal fistulas by autologous or commercial fibrin glue was suggested and the American FDA approved the use and marketing of a human fibrin glue in 1998. Since then, several studies have evaluated the effectiveness of human fibrin glue in the treatment of different types of perianal fistulas, reporting a wide range of success rates ranging from 31 to 85%. Primary aim of this study is to conduct a prospective randomized trial evaluating the effectiveness of glue treatment of perianal fistulas as compared with the classical seton treatment. Secondary aims are to compare postoperative faecal incontinence, postoperative anal pain, healing time and length of hospitalization.

Detailed Description
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Background: Fibrin glue treatment of anal fistulas has been proposed to minimize the risk of faecal incontinence but its acceptance by coloproctologists is still poor because clear data in literature are lacking. We will run a prospective randomised trial comparing commercial fibrin glue treatment with classical seton treatment, taking into account the healing rate, hospital stay, healing time, faecal incontinence and postoperative pain. Patients and Methods: 130 homogeneous patients with trans-sphincteric anal fistulas referred to 7 Colorectal Units will be randomised to undergo fibrin glue or seton treatment. permanent healing of the fistula will be defined as absence on any discharge from the fistula and healing of the secondary fistula orifice after at least 1 year of follow up. Post operative pain (on a VAS scale) and hospital stay will be recorded and compared in the two groups

Official Title
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Seton or Glue for Trans-sphincteric Anal Fistulas. A Prospective Randomised Clinical Trial

Conditions
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Anal Fistulas

Intervention / Treatment
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* Procedure: transsphincteric Seton positioning
* Procedure: glue (Tissucol) treatment
* Procedure: Fistula closing with biological glue
* Procedure: Seton positioning into the fistula tract


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: medium or high trans-sphincteric fistulas of cryptoglandular origin, no previous treatments Exclusion Criteria: Crohn's disease anal abscesses complex fistulas (horse-shoe type or multiple secondary tracts) immunosuppression diabetes, anal fissures pregnancy anti-coagulant treatments, any allergic reaction to the bioglue components.

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: glue (Tissucol ) treatment<br>patients with transsphincteric anal fistulas of cryptoglandular origin never operated on before | Procedure: glue (Tissucol) treatment<br>* After preparation of the fistula, a quantity of biological glue (Tissucol) is injected into the fistula tract<br>* Other names: fibrin glue treatment of perianal fistulas;Procedure: Fistula closing with biological glue<br>* After cleaning and disinfection of the fistula tract, abot 1-2 ml of Tissucol (biological Glue) is inserted into the fistula tract to close it<br>* Other names: fibrin glue treatment of perianal fistulas;|
| Active Comparator: Seton treatment<br>patients with transsphincteric anal fistulas of cryptoglandular origin never operated on before | Procedure: transsphincteric Seton positioning<br>* A cutting seton is applied into the fistula tract<br>* Other names: seton treatment of the fistula;Procedure: Seton positioning into the fistula tract<br>* Under spinal anesthesia a Seton is positioned into the fistula tract.<br>* Other names: loose seton, cutting seton for anal fistulas;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fistula healing (absence of any discharge from the external fistula opening and complete healing of the external fistulas opening after at least 1 year of follow-up). The analysis of the population is not intention to treat. |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fecal continence and in-hospital stay |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fibrin glue, transsphincteric anal fistulas, seton, incontinence, prospective randomised trial