Seton or Glue for Trans-sphincteric Anal Fistulas

Anal Fistulas Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00929630
• Other study ID #: SICCR 10/2006
• Status: Terminated
• Phase: Phase 3
• First received: March 30, 2009
• Last updated: September 15, 2009
• Start date: January 2006
• Est. completion date: June 2007

Study information

• Verified date: September 2009
• Source: Societa Italiana di Chirurgia ColoRettale
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 65
• Est. completion date: June 2007
• Est. primary completion date: May 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anal Fistulas
• Fistula
• Rectal Fistula

Intervention

Procedure:
• transsphincteric Seton positioning
A cutting seton is applied into the fistula tract
• glue (Tissucol) treatment
After preparation of the fistula, a quantity of biological glue (Tissucol) is injected into the fistula tract
• 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
• Seton positioning into the fistula tract
Under spinal anesthesia a Seton is positioned into the fistula tract.

Locations

Country	Name	City	State
Italy	Dept of Emergency and Organ transplantation - University of Bari	Bari

Sponsors (1)

Lead Sponsor	Collaborator
Societa Italiana di Chirurgia ColoRettale

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Fecal continence and in-hospital stay		12 months	Yes