Anal Crohn Fistula Surgery (FACC)

June 6, 2012 updated by: French Society of Coloproctology

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")

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

180

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Marseille, France, 13915
        • Not yet recruiting
        • Hôpital Nord de Marseille - Gastroenterology Department
        • Contact:
        • Principal Investigator:
          • Jean-Charles GRIMAUD, MD
      • Poissy, France, 78303
        • Not yet recruiting
        • Hôpital de Poissy
        • Contact:
        • Principal Investigator:
          • Béatrice VINSON-BONNET, MD
      • Saint-Nazaire, France, 44600
        • Not yet recruiting
        • Polyclinique de l'Océan
        • Contact:
        • Principal Investigator:
          • Florent JURCZAK, MD
    • Aquitaine
      • Bordeaux, Aquitaine, France, 33075
        • Recruiting
        • CHU Bordeaux - Hôpital Saint André - Department of Hepato Gastroenterology
        • Contact:
        • Principal Investigator:
          • Pauline Roumeguère-Blond, MD
      • Talence, Aquitaine, France, 33401
        • Recruiting
        • Maison de Santé Protestante de Bordeaux Bagatelle - Department of Proctology
        • Contact:
        • Principal Investigator:
          • Dominique BOUCHARD, MD
    • Bretagne
      • Rennes, Bretagne, France, 35033
        • Not yet recruiting
        • CHU Pontchaillou - Department of Digestive Diseases
        • Contact:
        • Principal Investigator:
          • Laurent Siproudhis, MD, PhD
    • Franche-Comté
      • Besançon, Franche-Comté, France, 25052
        • Not yet recruiting
        • Polyclinique de Franche-Comté - Department of Proctological Surgery
        • Contact:
        • Principal Investigator:
          • Michel Fantoli, MD
    • Haute Normandie
      • Rouen, Haute Normandie, France, 76031
        • Not yet recruiting
        • CHU de Rouen - Departement of Hepato Gastroenterologie and Nutrition
        • Contact:
        • Principal Investigator:
          • Guillaume Savoye, MD
    • Ile-de-France
      • Colombes, Ile-de-France, France, 92700
        • Not yet recruiting
        • Hôpital Louis Mourier - Department of Hepato-Gastroentérologie
        • Contact:
        • Principal Investigator:
          • Benoît Coffin, Prof., MD
      • Paris, Ile-de-France, France, 75014
        • Recruiting
        • Institut de Proctologie Léopold Bellan - Groupe Hospitalier Paris Saint Joseph - Department of Colo-Proctology
        • Contact:
        • Principal Investigator:
          • Sénéjoux Agnès, MD
      • Paris, Ile-de-France, France, 75014
        • Not yet recruiting
        • Institut Mutualiste Montsouris - Proctology Unit
        • Contact:
        • Principal Investigator:
          • Philippe Godeberge, MD
      • Paris, Ile-de-France, France, 75877
        • Recruiting
        • Hôpital Bichat-Claude Bernard - Gastro-enterology Department
        • Principal Investigator:
          • Laurent Abramowitz, MD
        • Contact:
    • Midi-Pyrénées
      • Cornebarrieu, Midi-Pyrénées, France, 31700
        • Recruiting
        • Clinique des Cèdres - Hepato-Gastroenterology Department
        • Contact:
        • Principal Investigator:
          • Guillaume Bonnaud, MD
      • Toulouse, Midi-Pyrénées, France, 31077
        • Not yet recruiting
        • Clinique Saint Jean Languedoc - Department of Gastroenterology
        • Contact:
        • Principal Investigator:
          • Ghislain Staumont, MD
    • Rhône-Alpes
      • Grenoble, Rhône-Alpes, France, 38043
        • Recruiting
        • Clinique universitaire de chirurgie Digestive et de l'urgence, Hopital Universitaire Michallon - Colorectal Surgery Unit
        • Contact:
        • Principal Investigator:
          • Jean-Luc Faucheron, Prof., MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of patients having a clinical healing of their anoperineal fistulas in Crohn disease
Time Frame: 12 months after seton drain removal
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
Time Frame: 3, 6, 12 and 24 months after seton drain removal
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)
Time Frame: 3, 6, 12 and 24 months after seton drain removal
3, 6, 12 and 24 months after seton drain removal
Change in anal continence assessed by Wexner and Vaizey scores
Time Frame: 12 and 24 months after seton drain removal
12 and 24 months after seton drain removal
Crohn's Disease Endoscopic Index of Severity (CDEIS)
Time Frame: 12 months after seton drain removal
12 months after seton drain removal
Change in patients' quality of life, assessed by the Inflammatory Bowel Disease Questionnaire (IBDQ)
Time Frame: 12 and 24 months after seton drain removal
12 and 24 months after seton drain removal
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
6, 12 and 24 months after seton drain removal
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
3, 6, 12 and 24 months after seton drain removal

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

French Society of Coloproctology

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (Anticipated)

March 1, 2016

Study Completion (Anticipated)

March 1, 2017

Study Registration Dates

First Submitted

July 4, 2011

First Submitted That Met QC Criteria

July 4, 2011

First Posted (Estimate)

July 6, 2011

Study Record Updates

Last Update Posted (Estimate)

June 7, 2012

Last Update Submitted That Met QC Criteria

June 6, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SNFCP-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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