Seton or Glue for Trans-sphincteric Anal Fistulas

Societa Italiana di Chirurgia ColoRettale

Status and phase: Terminated; Phase 3

Conditions: Anal Fistulas

Treatments: Procedure: Seton positioning into the fistula tract; Procedure: Fistula closing with biological glue; Procedure: glue (Tissucol) treatment; Procedure: transsphincteric Seton positioning

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT00929630

SICCR 10/2006

Details and patient eligibility

About

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.

Full 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

Enrollment: 65 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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65 participants in 2 patient groups

glue (Tissucol ) treatment

Experimental group

Description:

patients with transsphincteric anal fistulas of cryptoglandular origin never operated on before

Treatment:

Procedure: glue (Tissucol) treatment

Procedure: Fistula closing with biological glue

Seton treatment

Active Comparator group

Description:

patients with transsphincteric anal fistulas of cryptoglandular origin never operated on before

Treatment:

Procedure: transsphincteric Seton positioning

Procedure: Seton positioning into the fistula tract