Surgical closure, mainly with glue injection and anti tnf alpha, in fistulizing perianal crohn's disease: A multicenter randomised controlled trial.

AIM In patients with fistulizing perianal Crohn's Disease (FPCD), the need for a secondary surgical step is not defined. The aim was to assess the efficacy of surgical closure compared to a single seton removal in patients with drained FPCD treated by adalimumab METHODS: This was a multicenter, randomized controlled trial, comparing seton removal + surgical closure [closure group] to seton removal alone [control group] with a stratification according to AGA classification. Primary end point was fistula closure at month 12 defined by the association of the following criteria: no seton, absence of a visible external opening, absence of discharge from the tract after finger compression, absence of an internal opening, absence of perianal pain/abscess and absence of fistula-related abnormalities. RESULTS Among the 64 included patients (262 expected) (48 complex fistula, 75%), 33 were randomized to the closure group and 31 to the control group. In the closure group, 26 patients (78.8%) had glue. At month 12, overall fistula closure was achieved in 35 of the evaluable 58 patients (60%): 18/32 (56%) in the surgery group and 17/26 (65%) in the control group (p=0.479). In the closure group, fistula closure was observed in 13/25 (52%) and 5/7 (71%) patients with complex and simple fistula respectively (p=0.426), as compared with 12/18 (67%) and 5/8 (63%), respectively in control group (p=1.000). CONCLUSIONS Seton removal alone seems to be no more effective than secondary surgical (in particular glue injection) in patients having fistulizing perianal CD controlled by an initial drainage combined with adalimumab. The results should be interpreted with caution.