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")

French Society of Coloproctology15 sites in 1 country180 target enrollmentOctober 2011

ConditionsCrohn Disease Fistula Anoperineal Fistula Anal Fistula

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Crohn Disease
Sponsor: French Society of Coloproctology
Enrollment: 180
Locations: 15
Primary Endpoint: Percentage of patients having a clinical healing of their anoperineal fistulas in Crohn disease
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

October 2011

End Date

March 2017

Last Updated

13 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

French Society of Coloproctology

Responsible Party

Sponsor

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.

Outcomes

Primary Outcomes

Percentage of patients having a clinical healing of their anoperineal fistulas in Crohn disease

Time Frame: 12 months after seton drain removal

Secondary Outcomes

Change in fistula activity assessed by magnetic resonance imaging (MRI)(6, 12 and 24 months after seton drain removal)
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)