Anal Crohn Fistula Surgery

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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Fistula, Crohn Disease, Anoperineal Fistula, Anal Fistula

Intervention / Treatment
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* Procedure: All types of surgery procedures
* Procedure: Simple seton drain removal


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Surgery<br>Seton drain removal is associated with proctological surgery. | Procedure: All types of surgery procedures<br>* All types of surgery procedures used for anoperineal fistula repair. Surgery procedures include fistulotomy, biological glue, rectal advancement flap and plug.<br>|
| Other: Simple seton drain removal<br> | Procedure: Simple seton drain removal<br>* Patients are simply followed after seton drain removal.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients having a clinical healing of their anoperineal fistulas in Crohn disease |  | 12 months after seton drain removal | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients having more than half of their fistulas healed |  | 3, 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 patients' quality of life, assessed by the Inflammatory Bowel Disease Questionnaire (IBDQ) |  | 12 and 24 months after seton drain removal | 
| Change in fistula activity assessed by magnetic resonance imaging (MRI) | Change in fistula activity assessed by MRI (Van Assche score and absence of contrast enhancement after injection of gadolinium with regards to fistulous tract | 6, 12 and 24 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Crohn Disease, Anoperineal fistula, Anal fistula, Proctology, Drainage, Colorectal Surgery, Fistulotomy, Plug, Advancement flap, Glue, Anti Tumor Necrosis Factor-alpha, Adalimumab