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

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

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)

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.