Fibrin Glue for Perianal Fistulas in Crohn's Disease: a Randomized Controlled Trial (Fibrin glue)

September 2, 2011 updated by: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
This multicenter, randomized, controlled trial was conducted by the Groupe d'Etude Thérapeutique des Affections Inflammatoires du tube Digestif (GETAID) to evaluate the efficacy and safety of the injection of fibrin glue in perianal fistulas tracts of patients with CD. The institutional Independent Ethics Committee of Marseille, France and of Liège, Belgium approved the protocol for each participating centers. Recruitment took place at 12 sites (11 in France and 1 in Belgium)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

77

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

  • Belgium
      • Liege, Belgium, 4000
        • Sart Tilman University Hospital
  • France
      • Clichy, France, 92110
        • Beaujon Hospital
      • Colombes, France, 92700
        • Louis Mourrier Hospital
      • Lille, France
        • Chru Lille
      • Marseille, France, 13915
        • Marseille North Hospital
      • Nice, France, 06202
        • Nice University Hospital
      • Paris, France, 75010
        • Lariboisière Hospital
      • Paris, France, 75018
        • Bichat Hospital
      • Paris, France, 75010
        • Hopital St Louis
      • Paris, France, 75015
        • Georges Pompidou European Hospital
      • Pierre Benite, France, 69495
        • Lyon Sud University Hospital
      • Rennes, France, 35033
        • Pontchaillou University Hospital
      • Rouen, France, 76031
        • Rouen University Hospital
      • Tours, France, 37044
        • Trousseau University Hospital

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 and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • at least 18 years old
  • CD confirmed by endoscopy and histology.
  • CDAI should be 250 or less
  • at least one perianal fistula (between anus or low rectum and perineum, vulva or vagina) draining for more than 2 months duration

Exclusion Criteria:

  • treatment with an anti-TNF agent or with ciclosporin or tacrolimus within the last 3 months
  • presence of a perianal abscess (>1cm) assessed by magnetic resonance imaging (MRI) or endo-anal ultrasonography performed within the last month,
  • presence of anal or rectal stenosis,
  • surgery during the previous month (except seton removal),
  • previous fibrin glue injection,
  • pregnancy.

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: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
Procedure: Fibrin glue injection in fistula

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Remission
Time Frame: 8 weeks after inclusion

Clinical remission was defined as

  • the absence of any draining by fistula openings occurring spontaneously or after gentle finger compression ,
  • the absence of perianal pain
  • and the absence of perianal abscess.
8 weeks after inclusion

Secondary Outcome Measures

Outcome Measure
Time Frame
Early Clinical Remission
Time Frame: 4 weeks after Inclusion
4 weeks after Inclusion
Occurrence of perianal abcess
Time Frame: During whole study
During whole study

Collaborators and Investigators

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

Sponsor

Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

Collaborators

Société Nationale Française de Gastroentérologie
Nycomed

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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

November 1, 2003

Primary Completion (ACTUAL)

June 1, 2006

Study Completion (ACTUAL)

August 1, 2006

Study Registration Dates

First Submitted

July 25, 2008

First Submitted That Met QC Criteria

July 25, 2008

First Posted (ESTIMATE)

July 28, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

September 5, 2011

Last Update Submitted That Met QC Criteria

September 2, 2011

Last Verified

September 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GETAID 2003-1

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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