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)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
77
Sart Tilman University Hospital
Liège, Belgium
Beaujon Hospital
Clichy, France
Louis Mourrier Hospital
Colombes, France
Clinical Remission
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.
Time frame: 8 weeks after inclusion
Early Clinical Remission
Time frame: 4 weeks after Inclusion
Occurrence of perianal abcess
Time frame: During whole study
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CHRU Lille
Lille, France
Marseille North Hospital
Marseille, France
Nice University Hospital
Nice, France
Hopital St Louis
Paris, France
Lariboisiere Hospital
Paris, France
Georges Pompidou European Hospital
Paris, France
Bichat Hospital
Paris, France
...and 4 more locations