Fibrin Glue for Perianal Fistulas in Crohn's Disease: a Randomized Controlled Trial - Full Text View

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

This study has been terminated.

Sponsors and Collaborators:	Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives Nycomed SNFGE
Information provided by:	Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
ClinicalTrials.gov Identifier:	NCT00723047

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 III

Genetics Home Reference related topics: Crohn disease

MedlinePlus related topics: Crohn's Disease Fistulas

Drug Information available for: Fibrin Beriplast

U.S. FDA Resources

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

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

Study Start Date:	November 2003
Study Completion Date:	August 2006

Arms	Assigned Interventions
1: Experimental	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
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

Sponsors and Collaborators

Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

Nycomed

SNFGE

More Information

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

Keywords provided by Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives:

Patients
CD complicated
least

One perianal fistula
Draining
2 months duration

Study placed in the following topic categories:

Digestive System Diseases
Fibrin Tissue Adhesive
Gastrointestinal Diseases
Crohn Disease

Inflammatory Bowel Diseases
Gastroenteritis
Intestinal Diseases
Fistula

Additional relevant MeSH terms:

Coagulants
Therapeutic Uses
Hematologic Agents
Pharmacologic Actions
Hemostatics

ClinicalTrials.gov processed this record on January 16, 2009