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

Phase 3

Completed

• Conditions: Crohn's Disease
• Interventions: Procedure: Fibrin glue injection in fistula

• Registration Number: NCT00723047
• Lead Sponsor: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

Brief Summary

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)

Detailed Description

Not available

Study Timeline

• Study Start: 2003-11
• Primary Completion: 2006-06
• Study Completion: 2006-08
• Study First Submitted: 2008-07-25
• Study First Submitted QC: 2008-07-25
• Study First Posted: 2008-07-28
• Status Verified: 2011-09
• Last Update Submitted: 2011-09-02
• Last Update Posted: 2011-09-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 77

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	Fibrin glue injection in fistula	-

Primary Outcome Measures

Name	Time	Method
Clinical Remission	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.

Secondary Outcome Measures

Name	Time	Method
Early Clinical Remission	4 weeks after Inclusion
Occurrence of perianal abcess	During whole study

Trial Locations

Locations (14)

CHRU Lille; 🇫🇷 Lille, France

Rouen University Hospital; 🇫🇷 Rouen, France

Bichat Hospital; 🇫🇷 Paris, France

Nice University Hospital; 🇫🇷 Nice, France

Sart Tilman University Hospital; 🇧🇪 Liege, Belgium

Lyon Sud University Hospital; 🇫🇷 Pierre Benite, France

Lariboisiere Hospital; 🇫🇷 Paris, France

Beaujon Hospital; 🇫🇷 Clichy, France

Louis Mourrier Hospital; 🇫🇷 Colombes, France

Trousseau University Hospital; 🇫🇷 Tours, France

Marseille North Hospital; 🇫🇷 Marseille, France

Pontchaillou University Hospital; 🇫🇷 Rennes, France

Hopital St Louis; 🇫🇷 Paris, France

Georges Pompidou European Hospital; 🇫🇷 Paris, France