Seton or Glue for Trans-sphincteric Anal Fistulas

This study has been terminated.
(Evident advantages of one treatment (seton) over the other (Tissucol Glue))
Sponsor:
Information provided by:
Societa Italiana di Chirurgia ColoRettale
ClinicalTrials.gov Identifier:
NCT00929630
First received: March 30, 2009
Last updated: September 15, 2009
Last verified: September 2009
  Purpose

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.


Condition Intervention Phase
Anal Fistulas
Procedure: transsphincteric Seton positioning
Procedure: glue (Tissucol) treatment
Procedure: Fistula closing with biological glue
Procedure: Seton positioning into the fistula tract
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Seton or Glue for Trans-sphincteric Anal Fistulas. A Prospective Randomised Clinical Trial

Resource links provided by NLM:


Further study details as provided by Societa Italiana di Chirurgia ColoRettale:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Fecal continence and in-hospital stay [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Enrollment: 65
Study Start Date: January 2006
Study Completion Date: June 2007
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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 Name: seton treatment of the fistula
Procedure: Seton positioning into the fistula tract
Under spinal anesthesia a Seton is positioned into the fistula tract.
Other Name: loose seton, cutting seton for anal fistulas

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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00929630

Locations
Italy
Dept of Emergency and Organ transplantation - University of Bari
Bari, Italy, 70124
Sponsors and Collaborators
Societa Italiana di Chirurgia ColoRettale
Investigators
Principal Investigator: Donato F Altomare, MD University of Bari, Italy
  More Information

No publications provided

Responsible Party: Donato F Altomare, Italian Society of Colorectal surgery
ClinicalTrials.gov Identifier: NCT00929630     History of Changes
Other Study ID Numbers: SICCR 10/2006
Study First Received: March 30, 2009
Last Updated: September 15, 2009
Health Authority: Italy: Ethics Committee

Keywords provided by Societa Italiana di Chirurgia ColoRettale:
fibrin glue
transsphincteric anal fistulas
seton
incontinence
prospective randomised trial

Additional relevant MeSH terms:
Fistula
Rectal Fistula
Pathological Conditions, Anatomical
Intestinal Fistula
Digestive System Fistula
Digestive System Diseases
Intestinal Diseases
Gastrointestinal Diseases
Rectal Diseases
Fibrin Tissue Adhesive
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014