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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
180

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
French Society of Coloproctology

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Laurent Abramowitz, MD, Hôpital 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2011

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2016

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 4, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 4, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 6, 2011

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 7, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 6, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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