Anal Crohn Fistula Surgery

Not Applicable

• Conditions: Anal Fistula; Anoperineal Fistula; Crohn Disease; Fistula
• Interventions: Procedure: All types of surgery procedures; Procedure: Simple seton drain removal

• Registration Number: NCT01388257
• Lead Sponsor: French Society of Coloproctology

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-07-04
• Study First Submitted QC: 2011-07-04
• Study First Posted: 2011-07-06
• Study Start: 2011-10
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-06
• Last Update Posted: 2012-06-07
• Primary Completion: 2016-03
• Study Completion: 2017-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 180

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Surgery	All types of surgery procedures	Seton drain removal is associated with proctological surgery.
Simple seton drain removal	Simple seton drain removal	-

Primary Outcome Measures

Name	Time	Method
Percentage of patients having a clinical healing of their anoperineal fistulas in Crohn disease	12 months after seton drain removal

Secondary Outcome Measures

Name	Time	Method
Change in fistula activity assessed by magnetic resonance imaging (MRI)	6, 12 and 24 months after seton drain removal	Change in fistula activity assessed by MRI (Van Assche score and absence of contrast enhancement after injection of gadolinium with regards to fistulous tract
Change in Crohn disease activity assessed by Crohn's Disease Activity Index (CDAI) and Perianal Disease Activity Index (PDAI)	3, 6, 12 and 24 months after seton drain removal
Change in anal continence assessed by Wexner and Vaizey scores	12 and 24 months after seton drain removal
Crohn's Disease Endoscopic Index of Severity (CDEIS)	12 months after seton drain removal
Change in discomfort and impact assessed by the patient using a visual analog scale (VAS)	3, 6, 12 and 24 months after seton drain removal
Proportion of patients having more than half of their fistulas healed	3, 6, 12 and 24 months after seton drain removal
Change in patients' quality of life, assessed by the Inflammatory Bowel Disease Questionnaire (IBDQ)	12 and 24 months after seton drain removal

Trial Locations

Locations (15)

CHU Bordeaux - Hôpital Saint André - Department of Hepato Gastroenterology; 🇫🇷 Bordeaux, Aquitaine, France

Maison de Santé Protestante de Bordeaux Bagatelle - Department of Proctology; 🇫🇷 Talence, Aquitaine, France

CHU Pontchaillou - Department of Digestive Diseases; 🇫🇷 Rennes, Bretagne, France

Polyclinique de Franche-Comté - Department of Proctological Surgery; 🇫🇷 Besançon, Franche-Comté, France

CHU de Rouen - Departement of Hepato Gastroenterologie and Nutrition; 🇫🇷 Rouen, Haute Normandie, France

Hôpital Louis Mourier - Department of Hepato-Gastroentérologie; 🇫🇷 Colombes, Ile-de-France, France

Institut de Proctologie Léopold Bellan - Groupe Hospitalier Paris Saint Joseph - Department of Colo-Proctology; 🇫🇷 Paris, Ile-de-France, France

Institut Mutualiste Montsouris - Proctology Unit; 🇫🇷 Paris, Ile-de-France, France

Hôpital Bichat-Claude Bernard - Gastro-enterology Department; 🇫🇷 Paris, Ile-de-France, France

Clinique des Cèdres - Hepato-Gastroenterology Department; 🇫🇷 Cornebarrieu, Midi-Pyrénées, France

Clinique Saint Jean Languedoc - Department of Gastroenterology; 🇫🇷 Toulouse, Midi-Pyrénées, France

Clinique universitaire de chirurgie Digestive et de l'urgence, Hopital Universitaire Michallon - Colorectal Surgery Unit; 🇫🇷 Grenoble, Rhône-Alpes, France

Hôpital Nord de Marseille - Gastroenterology Department; 🇫🇷 Marseille, France

Hôpital de POISSY; 🇫🇷 Poissy, France

Polyclinique de l'Océan; 🇫🇷 Saint-Nazaire, France