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Anal Crohn Fistula Surgery (FACC)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2012 by French Society of Coloproctology
Sponsor:
Information provided by (Responsible Party):
French Society of Coloproctology
ClinicalTrials.gov Identifier:
NCT01388257
First received: July 4, 2011
Last updated: June 6, 2012
Last verified: June 2012
  Purpose

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 Intervention
Crohn Disease
Fistula
Anoperineal Fistula
Anal Fistula
Procedure: All types of surgery procedures
Procedure: Simple seton drain removal

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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")

Resource links provided by NLM:


Further study details as provided by French Society of Coloproctology:

Primary Outcome Measures:
  • Percentage of patients having a clinical healing of their anoperineal fistulas in Crohn disease [ Time Frame: 12 months after seton drain removal ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of patients having more than half of their fistulas healed [ Time Frame: 3, 6, 12 and 24 months after seton drain removal ] [ Designated as safety issue: No ]
  • Change in Crohn disease activity assessed by Crohn's Disease Activity Index (CDAI) and Perianal Disease Activity Index (PDAI) [ Time Frame: 3, 6, 12 and 24 months after seton drain removal ] [ Designated as safety issue: No ]
  • Change in anal continence assessed by Wexner and Vaizey scores [ Time Frame: 12 and 24 months after seton drain removal ] [ Designated as safety issue: No ]
  • Crohn's Disease Endoscopic Index of Severity (CDEIS) [ Time Frame: 12 months after seton drain removal ] [ Designated as safety issue: No ]
  • Change in patients' quality of life, assessed by the Inflammatory Bowel Disease Questionnaire (IBDQ) [ Time Frame: 12 and 24 months after seton drain removal ] [ Designated as safety issue: No ]
  • Change in fistula activity assessed by magnetic resonance imaging (MRI) [ Time Frame: 6, 12 and 24 months after seton drain removal ] [ Designated as safety issue: No ]
    Change in fistula activity assessed by MRI (Van Assche score and absence of contrast enhancement after injection of gadolinium with regards to fistulous tract

  • Change in discomfort and impact assessed by the patient using a visual analog scale (VAS) [ Time Frame: 3, 6, 12 and 24 months after seton drain removal ] [ Designated as safety issue: No ]

Estimated Enrollment: 180
Study Start Date: October 2011
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Simple seton drain removal Procedure: Simple seton drain removal
Patients are simply followed after seton drain removal.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01388257

Contacts
Contact: Laurent Abramowitz, MD 140 50 11 22 ext +33 laurent.abramowitz@bch.ap-hop-paris.fr

Locations
France
CHU Bordeaux - Hôpital Saint André - Department of Hepato Gastroenterology Recruiting
Bordeaux, Aquitaine, France, 33075
Contact: Roumeguère-Blond       pauline.roumeguere@chu-bordeaux.fr   
Principal Investigator: Pauline Roumeguère-Blond, MD         
Maison de Santé Protestante de Bordeaux Bagatelle - Department of Proctology Recruiting
Talence, Aquitaine, France, 33401
Contact: Bouchard       proctobouc@gmail.com   
Principal Investigator: Dominique Bouchard, MD         
CHU Pontchaillou - Department of Digestive Diseases Not yet recruiting
Rennes, Bretagne, France, 35033
Contact: Siproudhis       laurent.siproudhis@chu-rennes.fr   
Principal Investigator: Laurent Siproudhis, MD, PhD         
Polyclinique de Franche-Comté - Department of Proctological Surgery Not yet recruiting
Besançon, Franche-Comté, France, 25052
Contact: Fantoli       drmichelfantoli@wanadoo.fr   
Principal Investigator: Michel Fantoli, MD         
CHU de Rouen - Departement of Hepato Gastroenterologie and Nutrition Not yet recruiting
Rouen, Haute Normandie, France, 76031
Contact: Savoye       guillaume.savoye@chu-rouen.fr   
Principal Investigator: Guillaume Savoye, MD         
Hôpital Louis Mourier - Department of Hepato-Gastroentérologie Not yet recruiting
Colombes, Ile-de-France, France, 92700
Contact: Coffin       benoit.coffin@lmr.ap-hop-paris.fr   
Principal Investigator: Benoît Coffin, Prof., MD         
Hôpital Bichat-Claude Bernard - Gastro-enterology Department Recruiting
Paris, Ile-de-France, France, 75877
Contact: Laurent Abramowitz, MD    1 43 74 61 41 ext +33    laurent.abramowitz@bch.ap-hop-paris.fr   
Principal Investigator: Laurent Abramowitz, MD         
Institut de Proctologie Léopold Bellan - Groupe Hospitalier Paris Saint Joseph - Department of Colo-Proctology Recruiting
Paris, Ile-de-France, France, 75014
Contact: Sénéjoux       agnes.senejoux@gmail.com   
Principal Investigator: Sénéjoux Agnès, MD         
Institut Mutualiste Montsouris - Proctology Unit Not yet recruiting
Paris, Ile-de-France, France, 75014
Contact: Godeberge       philippe.godeberge@wanadoo.fr   
Principal Investigator: Philippe Godeberge, MD         
Clinique des Cèdres - Hepato-Gastroenterology Department Recruiting
Cornebarrieu, Midi-Pyrénées, France, 31700
Contact: Bonnaud       hepavie@free.fr   
Principal Investigator: Guillaume Bonnaud, MD         
Clinique Saint Jean Languedoc - Department of Gastroenterology Not yet recruiting
Toulouse, Midi-Pyrénées, France, 31077
Contact: Staumont       staumont.ghislain@orange.fr   
Principal Investigator: Ghislain Staumont, MD         
Clinique universitaire de chirurgie Digestive et de l'urgence, Hopital Universitaire Michallon - Colorectal Surgery Unit Recruiting
Grenoble, Rhône-Alpes, France, 38043
Contact: Faucheron       jlfaucheron@chu-grenoble.fr   
Principal Investigator: Jean-Luc Faucheron, Prof., MD         
Hôpital Nord de Marseille - Gastroenterology Department Not yet recruiting
Marseille, France, 13915
Contact: Jean-Charles GRIMAUD, MD       jean-charles.grimaud@ap-hm.fr   
Principal Investigator: Jean-Charles GRIMAUD, MD         
Hôpital de POISSY Not yet recruiting
Poissy, France, 78303
Contact: Béatrice VINSON-BONNET, MD       bvinson-bonnet@chi-psg.com   
Principal Investigator: Béatrice VINSON-BONNET, MD         
Polyclinique de l'Océan Not yet recruiting
Saint-Nazaire, France, 44600
Contact: Florent JURCZAK, MD       florent.jurczak@mla.fr   
Principal Investigator: Florent JURCZAK, MD         
Sponsors and Collaborators
French Society of Coloproctology
Investigators
Principal Investigator: Laurent Abramowitz, MD Hôpital Bichat-Claude Bernard
  More Information

Additional Information:
No publications provided

Responsible Party: French Society of Coloproctology
ClinicalTrials.gov Identifier: NCT01388257     History of Changes
Other Study ID Numbers: SNFCP-001
Study First Received: July 4, 2011
Last Updated: June 6, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: Committee for the Protection of Personnes

Keywords provided by French Society of Coloproctology:
Anoperineal fistula
Anal fistula
Crohn Disease
Proctology
Drainage
Colorectal Surgery
Fistulotomy
Plug
Advancement flap
Glue
Anti Tumor Necrosis Factor-alpha
Adalimumab

Additional relevant MeSH terms:
Fistula
Crohn Disease
Digestive System Diseases
Gastroenteritis
Gastrointestinal Diseases
Inflammatory Bowel Diseases
Intestinal Diseases
Pathological Conditions, Anatomical
Adalimumab
Anti-Inflammatory Agents
Antirheumatic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014