Seton or Glue for Trans-sphincteric Anal Fistulas

September 15, 2009 updated by: Societa Italiana di Chirurgia ColoRettale

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

65

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Bari, Italy, 70124
        • Dept of Emergency and Organ transplantation - University of Bari

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: glue (Tissucol ) treatment
patients with transsphincteric anal fistulas of cryptoglandular origin never operated on before
Procedure: glue (Tissucol) treatment
After preparation of the fistula, a quantity of biological glue (Tissucol) is injected into the fistula tract
Other Names:
  • fibrin glue treatment of perianal fistulas
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
Other Names:
  • fibrin glue treatment of perianal fistulas
Active Comparator: Seton treatment
patients with transsphincteric anal fistulas of cryptoglandular origin never operated on before
Procedure: transsphincteric Seton positioning
A cutting seton is applied into the fistula tract
Other Names:
  • seton treatment of the fistula
Procedure: Seton positioning into the fistula tract
Under spinal anesthesia a Seton is positioned into the fistula tract.
Other Names:
  • loose seton, cutting seton for anal fistulas

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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.
Time Frame: 12 months
12 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Societa Italiana di Chirurgia ColoRettale

Investigators

  • Principal Investigator: Donato F Altomare, MD, University of Bari, Italy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Primary Completion (Actual)

May 1, 2007

Study Completion (Actual)

June 1, 2007

Study Registration Dates

First Submitted

March 30, 2009

First Submitted That Met QC Criteria

June 26, 2009

First Posted (Estimate)

June 29, 2009

Study Record Updates

Last Update Posted (Estimate)

September 16, 2009

Last Update Submitted That Met QC Criteria

September 15, 2009

Last Verified

September 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SICCR 10/2006

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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