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

Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

Status and phase

Completed

Phase 3

Conditions

Crohn's Disease

Treatments

Procedure: Fibrin glue injection in fistula

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00723047

GETAID 2003-1

Details and patient eligibility

About

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)

Enrollment

77 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.