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Sponsors and Collaborators: |
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives Nycomed SNFGE |
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Information provided by: | Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives |
ClinicalTrials.gov Identifier: | NCT00723047 |
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 |
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Crohn's Disease |
Procedure: Fibrin glue injection in fistula |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Crossover Assignment |
Official Title: | Fibrin Glue for Perianal Fistulas in Crohn's Disease: a Randomized Controlled Trial |
Study Start Date: | November 2003 |
Study Completion Date: | August 2006 |
Arms | Assigned Interventions |
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1: Experimental | Procedure: Fibrin glue injection in fistula |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Belgium | |
Sart Tilman University Hospital | |
LIEGE, Belgium, 4000 | |
France | |
Bichat Hospital | |
PARIS, France, 75018 | |
CHRU Lille | |
LILLE, France | |
Georges Pompidou European Hospital | |
PARIS, France, 75015 | |
Hopital St Louis | |
Paris, France, 75010 | |
Louis Mourrier Hospital | |
COLOMBES, France, 92700 | |
Lyon Sud University Hospital | |
PIERRE BENITE, France, 69495 | |
Beaujon Hospital | |
CLICHY, France, 92110 | |
Nice University Hospital | |
NICE, France, 06202 | |
Pontchaillou University Hospital | |
RENNES, France, 35033 | |
Trousseau University Hospital | |
TOURS, France, 37044 | |
Rouen University Hospital | |
ROUEN, France, 76031 | |
Lariboisiere Hospital | |
PARIS, France, 75010 | |
Marseille North Hospital | |
MARSEILLE, France, 13915 |
Responsible Party: | GETAID ( Marc LEMANN ) |
Study ID Numbers: | GETAID 2003-1 |
Study First Received: | July 25, 2008 |
Last Updated: | July 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00723047 |
Health Authority: | France: Ministry of Health; France: Institutional Ethical Committee |
Patients CD complicated least |
One perianal fistula Draining 2 months duration |
Digestive System Diseases Fibrin Tissue Adhesive Gastrointestinal Diseases Crohn Disease |
Inflammatory Bowel Diseases Gastroenteritis Intestinal Diseases Fistula |
Coagulants Therapeutic Uses Hematologic Agents Pharmacologic Actions Hemostatics |