- Fecal Incontinence
|Surgical closure, mainly with glue injection and anti-tumour necrosis factor a, in fistulizing perianal Crohn's disease: A multicentre randomized controlled trial
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
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.
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.