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Anal Crohn Fistula Surgery (FACC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01388257
Recruitment Status : Unknown
Verified June 2012 by French Society of Coloproctology.
Recruitment status was:  Recruiting
First Posted : July 6, 2011
Last Update Posted : June 7, 2012
Information provided by (Responsible Party):
French Society of Coloproctology

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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : October 2011
Estimated Primary Completion Date : March 2016
Estimated Study Completion Date : March 2017

Resource links provided by the National Library of Medicine

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.

Simple seton drain removal Procedure: Simple seton drain removal
Patients are simply followed after seton drain removal.

Primary Outcome Measures :
  1. Percentage of patients having a clinical healing of their anoperineal fistulas in Crohn disease [ Time Frame: 12 months after seton drain removal ]

Secondary Outcome Measures :
  1. Proportion of patients having more than half of their fistulas healed [ Time Frame: 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) [ Time Frame: 3, 6, 12 and 24 months after seton drain removal ]
  3. Change in anal continence assessed by Wexner and Vaizey scores [ Time Frame: 12 and 24 months after seton drain removal ]
  4. Crohn's Disease Endoscopic Index of Severity (CDEIS) [ Time Frame: 12 months after seton drain removal ]
  5. Change in patients' quality of life, assessed by the Inflammatory Bowel Disease Questionnaire (IBDQ) [ Time Frame: 12 and 24 months after seton drain removal ]
  6. Change in fistula activity assessed by magnetic resonance imaging (MRI) [ Time Frame: 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) [ Time Frame: 3, 6, 12 and 24 months after seton drain removal ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01388257

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Contact: Laurent Abramowitz, MD 140 50 11 22 ext +33

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CHU Bordeaux - Hôpital Saint André - Department of Hepato Gastroenterology Recruiting
Bordeaux, Aquitaine, France, 33075
Contact: Roumeguère-Blond   
Principal Investigator: Pauline Roumeguère-Blond, MD         
Maison de Santé Protestante de Bordeaux Bagatelle - Department of Proctology Recruiting
Talence, Aquitaine, France, 33401
Contact: Bouchard   
Principal Investigator: Dominique Bouchard, MD         
CHU Pontchaillou - Department of Digestive Diseases Not yet recruiting
Rennes, Bretagne, France, 35033
Contact: Siproudhis   
Principal Investigator: Laurent Siproudhis, MD, PhD         
Polyclinique de Franche-Comté - Department of Proctological Surgery Not yet recruiting
Besançon, Franche-Comté, France, 25052
Contact: Fantoli   
Principal Investigator: Michel Fantoli, MD         
CHU de Rouen - Departement of Hepato Gastroenterologie and Nutrition Not yet recruiting
Rouen, Haute Normandie, France, 76031
Contact: Savoye   
Principal Investigator: Guillaume Savoye, MD         
Hôpital Louis Mourier - Department of Hepato-Gastroentérologie Not yet recruiting
Colombes, Ile-de-France, France, 92700
Contact: Coffin   
Principal Investigator: Benoît Coffin, Prof., MD         
Institut de Proctologie Léopold Bellan - Groupe Hospitalier Paris Saint Joseph - Department of Colo-Proctology Recruiting
Paris, Ile-de-France, France, 75014
Contact: Sénéjoux   
Principal Investigator: Sénéjoux Agnès, MD         
Institut Mutualiste Montsouris - Proctology Unit Not yet recruiting
Paris, Ile-de-France, France, 75014
Contact: Godeberge   
Principal Investigator: Philippe Godeberge, 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   
Principal Investigator: Laurent Abramowitz, MD         
Clinique des Cèdres - Hepato-Gastroenterology Department Recruiting
Cornebarrieu, Midi-Pyrénées, France, 31700
Contact: Bonnaud   
Principal Investigator: Guillaume Bonnaud, MD         
Clinique Saint Jean Languedoc - Department of Gastroenterology Not yet recruiting
Toulouse, Midi-Pyrénées, France, 31077
Contact: Staumont   
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   
Principal Investigator: Jean-Luc Faucheron, Prof., MD         
Hôpital Nord de Marseille - Gastroenterology Department Not yet recruiting
Marseille, France, 13915
Contact: Jean-Charles GRIMAUD, MD   
Principal Investigator: Jean-Charles GRIMAUD, MD         
Hôpital de POISSY Not yet recruiting
Poissy, France, 78303
Contact: Béatrice VINSON-BONNET, MD   
Principal Investigator: Béatrice VINSON-BONNET, MD         
Polyclinique de l'Océan Not yet recruiting
Saint-Nazaire, France, 44600
Contact: Florent JURCZAK, MD   
Principal Investigator: Florent JURCZAK, MD         
Sponsors and Collaborators
French Society of Coloproctology
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Principal Investigator: Laurent Abramowitz, MD Hôpital Bichat-Claude Bernard
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Responsible Party: French Society of Coloproctology Identifier: NCT01388257    
Other Study ID Numbers: SNFCP-001
First Posted: July 6, 2011    Key Record Dates
Last Update Posted: June 7, 2012
Last Verified: June 2012
Keywords provided by French Society of Coloproctology:
Crohn Disease
Anoperineal fistula
Anal fistula
Colorectal Surgery
Advancement flap
Anti Tumor Necrosis Factor-alpha
Additional relevant MeSH terms:
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Crohn Disease
Rectal Fistula
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Pathological Conditions, Anatomical
Intestinal Fistula
Digestive System Fistula
Rectal Diseases