Anal Crohn Fistula Surgery

Crohn Disease Clinical Trial

— FACC  

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")

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01388257
• Other study ID #: SNFCP-001
• Status: Recruiting
• Phase: N/A
• First received: July 4, 2011
• Last updated: June 6, 2012
• Start date: October 2011
• Est. completion date: March 2017

Study information

• Verified date: June 2012
• Source: French Society of Coloproctology
• Contact: Laurent Abramowitz, MD
• Phone: 140 50 11 22
• Email: laurent.abramowitz[@]bch.ap-hop-paris.fr
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)France: Committee for the Protection of Personnes
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: March 2017
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anal Fistula
• Anoperineal Fistula
• Crohn Disease
• Fistula

Intervention

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.
• Simple seton drain removal
Patients are simply followed after seton drain removal.

Locations

Country	Name	City	State
France	Polyclinique de Franche-Comté - Department of Proctological Surgery	Besançon	Franche-Comté
France	CHU Bordeaux - Hôpital Saint André - Department of Hepato Gastroenterology	Bordeaux	Aquitaine
France	Hôpital Louis Mourier - Department of Hepato-Gastroentérologie	Colombes	Ile-de-France
France	Clinique des Cèdres - Hepato-Gastroenterology Department	Cornebarrieu	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 Bichat-Claude Bernard - Gastro-enterology Department	Paris	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 de POISSY	Poissy
France	CHU Pontchaillou - Department of Digestive Diseases	Rennes	Bretagne
France	CHU de Rouen - Departement of Hepato Gastroenterologie and Nutrition	Rouen	Haute Normandie
France	Polyclinique de l'Océan	Saint-Nazaire
France	Maison de Santé Protestante de Bordeaux Bagatelle - Department of Proctology	Talence	Aquitaine
France	Clinique Saint Jean Languedoc - Department of Gastroenterology	Toulouse	Midi-Pyrénées

Sponsors (1)

Lead Sponsor	Collaborator
French Society of Coloproctology

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients having a clinical healing of their anoperineal fistulas in Crohn disease		12 months after seton drain removal	No
Secondary	Proportion of patients having more than half of their fistulas healed		3, 6, 12 and 24 months after seton drain removal	No
Secondary	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	No
Secondary	Change in anal continence assessed by Wexner and Vaizey scores		12 and 24 months after seton drain removal	No
Secondary	Crohn's Disease Endoscopic Index of Severity (CDEIS)		12 months after seton drain removal	No
Secondary	Change in patients' quality of life, assessed by the Inflammatory Bowel Disease Questionnaire (IBDQ)		12 and 24 months after seton drain removal	No
Secondary	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	No
Secondary	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	No

External Links

•   SNFCP website