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

This study has been completed.
Sponsor:
Collaborators:
Nycomed: A Takeda Company
Société Nationale Française de Gastroentérologie
Information provided by (Responsible Party):
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
ClinicalTrials.gov Identifier:
NCT00723047
First received: July 25, 2008
Last updated: September 2, 2011
Last verified: September 2011
History of Changes
  Purpose

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)


Condition Intervention Phase
Crohn's Disease
 Procedure: Fibrin glue injection in fistula
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Fibrin Glue for Perianal Fistulas in Crohn's Disease: a Randomized Controlled Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives:

Primary Outcome Measures:
  • Clinical Remission [ Time Frame: 8 weeks after inclusion ] [ Designated as safety issue: No ]

    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.


Secondary Outcome Measures:
  • Early Clinical Remission [ Time Frame: 4 weeks after Inclusion ] [ Designated as safety issue: No ]
  • Occurrence of perianal abcess [ Time Frame: During whole study ] [ Designated as safety issue: No ]

Enrollment: 77
Study Start Date: November 2003
Study Completion Date: August 2006
Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Procedure: Fibrin glue injection in fistula

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00723047

Locations
Belgium
Sart Tilman University Hospital
Liege, Belgium, 4000
France
Beaujon Hospital
Clichy, France, 92110
Louis Mourrier Hospital
Colombes, France, 92700
CHRU Lille
Lille, France
Marseille North Hospital
Marseille, France, 13915
Nice University Hospital
Nice, France, 06202
Georges Pompidou European Hospital
Paris, France, 75015
Bichat Hospital
Paris, France, 75018
Lariboisiere Hospital
Paris, France, 75010
Hopital St Louis
Paris, France, 75010
Lyon Sud University Hospital
Pierre Benite, France, 69495
Pontchaillou University Hospital
Rennes, France, 35033
Rouen University Hospital
Rouen, France, 76031
Trousseau University Hospital
Tours, France, 37044
Sponsors and Collaborators
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
Nycomed: A Takeda Company
Société Nationale Française de Gastroentérologie
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
ClinicalTrials.gov Identifier: NCT00723047     History of Changes
Other Study ID Numbers: GETAID 2003-1
Study First Received: July 25, 2008
Last Updated: September 2, 2011
Health Authority: France: Ministry of Health
France: Institutional Ethical Committee

Keywords provided by Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives:
Patients
CD complicated
least
 One perianal fistula
Draining
2 months duration

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

ClinicalTrials.gov processed this record on May 19, 2013