Seton or Glue for Trans-sphincteric Anal Fistulas

Phase 3

Terminated

• Conditions: Anal Fistulas
• Interventions: Procedure: glue (Tissucol) treatment; Procedure: transsphincteric Seton positioning; Procedure: Fistula closing with biological glue; Procedure: Seton positioning into the fistula tract

• Registration Number: NCT00929630
• Lead Sponsor: Societa Italiana di Chirurgia ColoRettale

Brief Summary

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

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

Study Timeline

• Study Start: 2006-01
• Primary Completion: 2007-05
• Study Completion: 2007-06
• Study First Submitted: 2009-03-30
• Study First Submitted QC: 2009-06-26
• Study First Posted: 2009-06-29
• Status Verified: 2009-09
• Last Update Submitted: 2009-09-15
• Last Update Posted: 2009-09-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 65

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
glue (Tissucol ) treatment	glue (Tissucol) treatment	patients with transsphincteric anal fistulas of cryptoglandular origin never operated on before
glue (Tissucol ) treatment	Fistula closing with biological glue	patients with transsphincteric anal fistulas of cryptoglandular origin never operated on before
Seton treatment	transsphincteric Seton positioning	patients with transsphincteric anal fistulas of cryptoglandular origin never operated on before
Seton treatment	Seton positioning into the fistula tract	patients with transsphincteric anal fistulas of cryptoglandular origin never operated on before

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Fecal continence and in-hospital stay	12 months

Trial Locations

Locations (1)

Dept of Emergency and Organ transplantation - University of Bari; 🇮🇹 Bari, Italy