Status:
COMPLETED
Fibrin Glue for Perianal Fistulas in Crohn's Disease: a Randomized Controlled Trial
Lead Sponsor:
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
Collaborating Sponsors:
Nycomed
Société Nationale Française de Gastroentérologie
Conditions:
Crohn's Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 inje...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2006
Estimated Enrollment :
77 Patients enrolled
Trial Details
Trial ID
NCT00723047
Start Date
November 1 2003
End Date
August 1 2006
Last Update
September 5 2011
Active Locations (14)
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1
Sart Tilman University Hospital
Liège, Belgium, 4000
2
Beaujon Hospital
Clichy, France, 92110
3
Louis Mourrier Hospital
Colombes, France, 92700
4
CHRU Lille
Lille, France