Anal Crohn Fistula Surgery (FACC)

French Society of Coloproctology

Status: Unknown

Conditions: Fistula; Anoperineal Fistula; Anal Fistula; Crohn Disease

Treatments: Procedure: All types of surgery procedures; Procedure: Simple seton drain removal

Study type: Interventional

Funder types: Other

Identifiers

NCT01388257

SNFCP-001

Details and patient eligibility

About

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.

Enrollment: 180 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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180 participants in 2 patient groups

Surgery

Experimental group

Description:

Seton drain removal is associated with proctological surgery.

Treatment:

Procedure: All types of surgery procedures

Simple seton drain removal

Other group

Treatment:

Procedure: Simple seton drain removal