FACC: Anal Crohn Fistula Surgery

• Sponsor: French Society of Coloproctology (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01388257
• Collaborator: (none)
• Enrollment: 180
• Locations: 15
• Arms: 2
• Duration (Months): 65
• Patients Per Site: 12
• Patients Per Site Per Month: 0.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Crohn Disease; Fistula; Anoperineal Fistula; Anal Fistula	Procedure: All types of surgery procedures; Procedure: Simple seton drain removal	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 180 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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 Start Date: Oct 1, 2011
• Anticipated Primary Completion Date: Mar 1, 2016
• Anticipated Study Completion Date: Mar 1, 2017

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Percentage of patients having a clinical healing of their anoperineal fistulas in Crohn disease [12 months after seton drain removal]

Secondary Outcome Measures

1. Proportion of patients having more than half of their fistulas healed [3, 6, 12 and 24 months after seton drain removal]

2. 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]

3. Change in anal continence assessed by Wexner and Vaizey scores [12 and 24 months after seton drain removal]

4. Crohn's Disease Endoscopic Index of Severity (CDEIS) [12 months after seton drain removal]

5. Change in patients' quality of life, assessed by the Inflammatory Bowel Disease Questionnaire (IBDQ) [12 and 24 months after seton drain removal]

6. 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

7. 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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU Bordeaux - Hôpital Saint André - Department of Hepato Gastroenterology	Bordeaux	Aquitaine	France	33075
2	Maison de Santé Protestante de Bordeaux Bagatelle - Department of Proctology	Talence	Aquitaine	France	33401
3	CHU Pontchaillou - Department of Digestive Diseases	Rennes	Bretagne	France	35033
4	Polyclinique de Franche-Comté - Department of Proctological Surgery	Besançon	Franche-Comté	France	25052
5	CHU de Rouen - Departement of Hepato Gastroenterologie and Nutrition	Rouen	Haute Normandie	France	76031
6	Hôpital Louis Mourier - Department of Hepato-Gastroentérologie	Colombes	Ile-de-France	France	92700
7	Institut de Proctologie Léopold Bellan - Groupe Hospitalier Paris Saint Joseph - Department of Colo-Proctology	Paris	Ile-de-France	France	75014
8	Institut Mutualiste Montsouris - Proctology Unit	Paris	Ile-de-France	France	75014
9	Hôpital Bichat-Claude Bernard - Gastro-enterology Department	Paris	Ile-de-France	France	75877
10	Clinique des Cèdres - Hepato-Gastroenterology Department	Cornebarrieu	Midi-Pyrénées	France	31700
11	Clinique Saint Jean Languedoc - Department of Gastroenterology	Toulouse	Midi-Pyrénées	France	31077
12	Clinique universitaire de chirurgie Digestive et de l'urgence, Hopital Universitaire Michallon - Colorectal Surgery Unit	Grenoble	Rhône-Alpes	France	38043
13	Hôpital Nord de Marseille - Gastroenterology Department	Marseille		France	13915
14	Hôpital de POISSY	Poissy		France	78303
15	Polyclinique de l'Océan	Saint-Nazaire		France	44600

Sponsors and Collaborators

• French Society of Coloproctology

Investigators

• Principal Investigator: Laurent Abramowitz, MD, Hôpital Bichat-Claude Bernard

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: French Society of Coloproctology
• ClinicalTrials.gov Identifier: NCT01388257
• Other Study ID Numbers: SNFCP-001
• First Posted: Jul 6, 2011
• Last Update Posted: Jun 7, 2012
• Last Verified: Jun 1, 2012

• Keywords provided by French Society of Coloproctology: Crohn Disease; Anoperineal fistula; Anal fistula; Proctology; Drainage; Colorectal Surgery; Fistulotomy; Plug; Advancement flap; Glue; Anti Tumor Necrosis Factor-alpha; Adalimumab
• Additional relevant MeSH terms: Crohn Disease; Rectal Fistula; Fistula

Study Results

No Results Posted as of Jun 7, 2012