Clinical trial NCT01388257: Anal Crohn Fistula Surgery
Official title: A National, Multicenter, Randomized Open-Label Study of Proctological Surgery Efficacy on Anoperineal Fistulas Healing in Crohn's Disease Patients Treated With Adalimumab. (Official French Title: "Étude Nationale, Multicentrique, randomisée et en Ouvert de l'efficacité de la Chirurgie Proctologique Sur la Cicatrisation Des Fistules anopérinéales de la Maladie de Crohn Chez Des Patients traités Par Adalimumab")
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Crohn Disease
Fistula
Anoperineal Fistula
Anal Fistula
Keywords: Crohn Disease
Anoperineal fistula
Anal fistula
Proctology
Drainage
Colorectal Surgery
Fistulotomy
Plug
Advancement flap
Glue
Anti Tumor Necrosis Factor-alpha
Adalimumab
Lead sponsor: French Society of Coloproctology
Sponsor class: OTHER
First posted: 2011-07-06
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to demonstrate, in patients treated with adalimumab, the efficacy of proctological surgery in anoperineal fistula healing after the removal of seton drain.


Eligibility criteria: Inclusion Criteria:

* male or female 18 years or older,
* women of childbearing age who use an effective contraception method or women incapable of becoming pregnant \[(i.e. postmenopausal women for 1 year or surgically sterile (hysterectomy and/or bilateral oophorectomy)\],
* Patient with fistulizing anoperineal Crohn's disease. Anoperineal fistulas can be associated with ileal, colic or rectal lesions,
* Patient with at least 1 anoperineal fistula drained with a seton for more than 1 month,
* Patient treated with adalimumab for more than 1 month,
* Patient who agrees to undergo surgery for its drained fistula(s),
* Patient with immunosuppressive therapy (azathioprine, 6-mercaptopurine ou methotrexate) stable for at least 3 months or patients without immunosuppressive therapy,
* Patient who gave signed written informed consent after having received verbal explanation and written information related to the trial.

Exclusion Criteria:

* Pregnant or breastfeeding women,
* Patient having a perineal abscess,
* Patient with a high anovaginal fistula that cannot be treated, according to the investigator ,with fistulotomy, gluing, biodegradable plug or advancement flap,
* Patient treated with a daily dose of corticosteroids of more than 20 mg (a dose of more than 20 mg daily will be authorized during the study),
* Contraindication to proctological surgery on the drained fistula(s),
* Patient presenting with somatic or psychic signs or symptoms that are not compatible with his/her participation in the trial according to the investigator,
* Patient who participate in another clinical trial.

Primary outcomes:
measure: Percentage of patients having a clinical healing of their anoperineal fistulas in Crohn disease
timeFrame: 12 months after seton drain removal
Secondary outcomes:
measure: Proportion of patients having more than half of their fistulas healed
timeFrame: 3, 6, 12 and 24 months after seton drain removal
measure: Change in Crohn disease activity assessed by Crohn's Disease Activity Index (CDAI) and Perianal Disease Activity Index (PDAI)
timeFrame: 3, 6, 12 and 24 months after seton drain removal
measure: Change in anal continence assessed by Wexner and Vaizey scores
timeFrame: 12 and 24 months after seton drain removal
measure: Crohn's Disease Endoscopic Index of Severity (CDEIS)
timeFrame: 12 months after seton drain removal
measure: Change in patients' quality of life, assessed by the Inflammatory Bowel Disease Questionnaire (IBDQ)
timeFrame: 12 and 24 months after seton drain removal
measure: Change in fistula activity assessed by magnetic resonance imaging (MRI)
timeFrame: 6, 12 and 24 months after seton drain removal
measure: Change in discomfort and impact assessed by the patient using a visual analog scale (VAS)
timeFrame: 3, 6, 12 and 24 months after seton drain removal
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU Bordeaux - Hôpital Saint André - Department of Hepato Gastroenterology
state: Aquitaine
city: Talence
country: France
facility: Maison de Santé Protestante de Bordeaux Bagatelle - Department of Proctology
state: Aquitaine
city: Rennes
country: France
facility: CHU Pontchaillou - Department of Digestive Diseases
state: Bretagne
city: Besançon
country: France
facility: Polyclinique de Franche-Comté - Department of Proctological Surgery
state: Franche-Comté
city: Rouen
country: France
facility: CHU de Rouen - Departement of Hepato Gastroenterologie and Nutrition
state: Haute Normandie
city: Colombes
country: France
facility: Hôpital Louis Mourier - Department of Hepato-Gastroentérologie
state: Ile-de-France
city: Paris
country: France
facility: Institut de Proctologie Léopold Bellan - Groupe Hospitalier Paris Saint Joseph - Department of Colo-Proctology
state: Ile-de-France
city: Paris
country: France
facility: Institut Mutualiste Montsouris - Proctology Unit
state: Ile-de-France
city: Paris
country: France
facility: Hôpital Bichat-Claude Bernard - Gastro-enterology Department
state: Ile-de-France
city: Cornebarrieu
country: France
facility: Clinique des Cèdres - Hepato-Gastroenterology Department
state: Midi-Pyrénées
city: Toulouse
country: France
facility: Clinique Saint Jean Languedoc - Department of Gastroenterology
state: Midi-Pyrénées
city: Grenoble
country: France
facility: Clinique universitaire de chirurgie Digestive et de l'urgence, Hopital Universitaire Michallon - Colorectal Surgery Unit
state: Rhône-Alpes
city: Marseille
country: France
facility: Hôpital Nord de Marseille - Gastroenterology Department
city: Poissy
country: France
facility: Hôpital de POISSY
city: Saint-Nazaire
country: France
facility: Polyclinique de l'Océan
Study officials:
affiliation: Hôpital Bichat-Claude Bernard
name: Laurent Abramowitz, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Abramowitz L, Brochard C, Pigot F, Roumeguere P, Pillant H, Vinson Bonnet B, Faucheron JL, Senejoux A, Bonnaud G, Meurette G, Fayette JM, Train C, Staumont G, Siproudhis L, Bouchard D. Surgical closure, mainly with glue injection and anti-tumour necrosis factor alpha, 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.