NCT00929630

Seton or Glue for Trans-sphincteric Anal Fistulas

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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 65 (actual)
• Sponsor: Societa Italiana di Chirurgia ColoRettale · Network
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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

Conditions

• Anal Fistulas

Interventions

Type	Name	Description
PROCEDURE	transsphincteric Seton positioning	A cutting seton is applied into the fistula tract
PROCEDURE	glue (Tissucol) treatment	After preparation of the fistula, a quantity of biological glue (Tissucol) is injected into the fistula tract
PROCEDURE	Fistula closing with biological glue	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
PROCEDURE	Seton positioning into the fistula tract	Under spinal anesthesia a Seton is positioned into the fistula tract.

Timeline

• Start date: 2006-01-01
• Primary completion: 2007-05-01
• Completion: 2007-06-01
• First posted: 2009-06-29
• Last updated: 2009-09-16

Locations

1 site across 1 country: Italy