Colorectal Dis. 2022 Feb;24(2):210-219.doi: 10.1111/codi.15947. Epub 2021 Oct 23.

Laurent Abramowitz ^1 2, Charlène Brochard ^3 4, François Pigot ⁵, Pauline Roumeguere ⁶, Hélène Pillant ⁷, Béatrice Vinson Bonnet ⁸, Jean Luc Faucheron ⁹, Agnès Senéjoux ¹⁰, Guillaume Bonnaud ¹¹, Guillaume Meurette ¹², Jean Marie Fayette ¹³, Cécile Train ¹³, Ghislain Staumont ¹⁴, Laurent Siproudhis ^3 4, Dominique Bouchard ⁵

Author information

¹Service d'Hépato-gastroentérologie et Proctologie, Hôpital Bichat-Claude Bernard, Paris, France.

²Ramsay Général de Santé, Clinique Blomet, Paris, France.

³Service des Maladies de l'Appareil Digestif, CHU Pontchaillou, Université de Rennes 1, Rennes, France.

⁴CIC 1414, INPHY, Université de Rennes 1, Rennes, France.

⁵Service de Proctologie, Hôpital Bagatelle, Maison de Santé Protestante Bagatelle, Talence, France.

⁶Clinique Tivoli-Ducos, Bordeaux, France.

⁷Service de Proctologie, Groupe Hospitalier Paris Saint Joseph, Institut Léopold-Bellan, Paris, France.

⁸Service de Chirurgie Viscérale et Digestive, CHI, Poissy-St-Germain-en-Laye, Paris, France.

⁹Unité de Chirurgie Colo-rectale, Service de Chirurgie Digestive et de l'Urgence, Hôpital Michallon, CHUGA, Grenoble, France.

¹⁰CHP Saint-Grégoire, Saint-Grégoire, France.

¹¹Clinique Ambroise Paré, Toulouse, France.

¹²Clinique de Chirurgie Digestive et Endocrinienne (CCDE), Institut des Maladies de l'Appareil Digestif (IMAD), University Hospital of Nantes, Nantes, France.

¹³Société ClinSearch, Malakoff, France.

¹⁴Clinique Saint-Jean-Languedoc, Toulouse, France.

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.

Trial registration: ClinicalTrials.gov NCT01388257.