Surgical closure, mainly with glue injection and anti‐tumour necrosis factor α, in fistulizing perianal Crohn's disease: A multicentre randomized controlled trial. (23rd October 2021)

• Record Type: Journal Article
• Authors: Abramowitz, Laurent; Brochard, Charlène; Pigot, François; Roumeguere, Pauline; Pillant, Hélène; Vinson Bonnet, Béatrice; Faucheron, Jean Luc; Senéjoux, Agnès; Bonnaud, Guillaume; Meurette, Guillaume; Fayette, Jean Marie; Train, Cécile; Staumont, Ghislain; Siproudhis, Laurent; Bouchard, Dominique
• Is Part Of: Colorectal disease. Volume 24:Number 2(2022)
• Page Start: 210
• Page End: 219
• Publication Date: 2021-10-23
• Subjects: Crohn's disease -- fistulizing perianal -- seton removal -- surgical closure; Colon (Anatomy) -- Diseases -- Periodicals; Rectum -- Diseases -- Periodicals; 616.34
• DOI: 10.1111/codi.15947
• Languages: English
• ISSNs: 1462-8910

Abstract

Abstract: Aim: In patients with fistulizing perianal Crohn's disease (CD), 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 fistulizing perianal CD treated with adalimumab. Methods: This was a multicentre, randomized controlled trial, comparing seton removal + surgical closure (closure group) to seton removal alone (control group) with a stratification according to the American Gastroenterological Association classification. The 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), compared with 12/18 (67%) and 5/8 (63%), respectively in the control group ( P = 1.000). Conclusions: Seton removal alone seems to be no more effective than a secondary surgical step (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.