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Crohn DiseaseFACCNCT01388257

Anal Crohn Fistula Surgery

A study testing All types of surgery procedures and Simple seton drain removal in people with Crohn Disease and Fistula, run by French Society of Coloproctology at 15 sites in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Crohn Disease, Fistula, Anoperineal Fistula
What is being tested?
All types of surgery procedures and Simple seton drain removal
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
180 participants
Where
15 sitesFrance
Study dates
Oct 2011to Mar 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

15 sites in 1 country.

Laurent Abramowitz, MD contact

140 50 11 22 ext. +33

laurent.abramowitz@bch.ap-hop-paris.fr

15 sites in 1 country

France15 sites, 15 recruiting

  • Polyclinique de Franche-Comté - Department of Proctological Surgery

    Besançon, Franche-Comté, 25052

    Fantoli, drmichelfantoli@wanadoo.fr

    Michel Fantoli, MD

    Not yet recruiting

  • CHU Bordeaux - Hôpital Saint André - Department of Hepato Gastroenterology

    Bordeaux, Aquitaine, 33075

    Roumeguère-Blond, pauline.roumeguere@chu-bordeaux.fr

    Pauline Roumeguère-Blond, MD

    Recruiting

  • Hôpital Louis Mourier - Department of Hepato-Gastroentérologie

    Colombes, Île-de-France Region, 92700

    Coffin, benoit.coffin@lmr.ap-hop-paris.fr

    Benoît Coffin, Prof., MD

    Not yet recruiting

  • Clinique des Cèdres - Hepato-Gastroenterology Department

    Cornebarrieu, Midi-Pyrénées, 31700

    Bonnaud, hepavie@free.fr

    Guillaume Bonnaud, MD

    Recruiting

  • Clinique universitaire de chirurgie Digestive et de l'urgence, Hopital Universitaire Michallon - Colorectal Surgery Unit

    Grenoble, Auvergne-Rhône-Alpes, 38043

    Faucheron, jlfaucheron@chu-grenoble.fr

    Jean-Luc Faucheron, Prof., MD

    Recruiting

  • Hôpital Nord de Marseille - Gastroenterology Department

    Marseille, 13915

    Jean-Charles GRIMAUD, MD, jean-charles.grimaud@ap-hm.fr

    Jean-Charles GRIMAUD, MD

    Not yet recruiting

  • Institut de Proctologie Léopold Bellan - Groupe Hospitalier Paris Saint Joseph - Department of Colo-Proctology

    Paris, Île-de-France Region, 75014

    Sénéjoux, agnes.senejoux@gmail.com

    Sénéjoux Agnès, MD

    Recruiting

  • Institut Mutualiste Montsouris - Proctology Unit

    Paris, Île-de-France Region, 75014

    Godeberge, philippe.godeberge@wanadoo.fr

    Philippe Godeberge, MD

    Not yet recruiting

  • Hôpital Bichat-Claude Bernard - Gastro-enterology Department

    Paris, Île-de-France Region, 75877

    Laurent Abramowitz, MD, 1 43 74 61 41 ext. +33, laurent.abramowitz@bch.ap-hop-paris.fr

    Laurent Abramowitz, MD

    Recruiting

  • Hôpital de POISSY

    Poissy, 78303

    Béatrice VINSON-BONNET, MD, bvinson-bonnet@chi-psg.com

    Béatrice VINSON-BONNET, MD

    Not yet recruiting

  • CHU Pontchaillou - Department of Digestive Diseases

    Rennes, Brittany Region, 35033

    Siproudhis, laurent.siproudhis@chu-rennes.fr

    Laurent Siproudhis, MD, PhD

    Not yet recruiting

  • CHU de Rouen - Departement of Hepato Gastroenterologie and Nutrition

    Rouen, Haute Normandie, 76031

    Savoye, guillaume.savoye@chu-rouen.fr

    Guillaume Savoye, MD

    Not yet recruiting

  • Polyclinique de l'Océan

    Saint-Nazaire, 44600

    Florent JURCZAK, MD, florent.jurczak@mla.fr

    Florent JURCZAK, MD

    Not yet recruiting

  • Maison de Santé Protestante de Bordeaux Bagatelle - Department of Proctology

    Talence, Aquitaine, 33401

    Bouchard, proctobouc@gmail.com

    Dominique Bouchard, MD

    Recruiting

  • Clinique Saint Jean Languedoc - Department of Gastroenterology

    Toulouse, Midi-Pyrénées, 31077

    Staumont, staumont.ghislain@orange.fr

    Ghislain Staumont, MD

    Not yet recruiting

Other trials in France

About this study

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")

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.

Being tested
All types of surgery procedures, Simple seton drain removal
Keywords
Crohn Disease, Anoperineal fistula, Anal fistula, Proctology, Drainage, Colorectal Surgery, Fistulotomy, Plug, Advancement flap, Glue, Anti Tumor Necrosis Factor-alpha, Adalimumab
Medical subject headings
Crohn Disease, Fistula, Rectal Fistula

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • All types of surgery proceduresProcedure or surgery

    All types of surgery procedures used for anoperineal fistula repair. Surgery procedures include fistulotomy, biological glue, rectal advancement flap and plug.

  • Simple seton drain removalProcedure or surgery

    Patients are simply followed after seton drain removal.

Study groups in NCT01388257
Study groupRoleWhat they receive
SurgeryExperimentalSeton drain removal is associated with proctological surgery.
Receives: Procedure: All types of surgery procedures
Simple seton drain removalOtherNot described
Receives: Procedure: Simple seton drain removal

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of patients having a clinical healing of their anoperineal fistulas in Crohn disease

    Measured: 12 months after seton drain removal

Secondary outcomes (7)

  1. Proportion of patients having more than half of their fistulas healed

    Measured: 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)

    Measured: 3, 6, 12 and 24 months after seton drain removal

  3. Change in anal continence assessed by Wexner and Vaizey scores

    Measured: 12 and 24 months after seton drain removal

  4. Crohn's Disease Endoscopic Index of Severity (CDEIS)

    Measured: 12 months after seton drain removal

  5. Change in patients' quality of life, assessed by the Inflammatory Bowel Disease Questionnaire (IBDQ)

    Measured: 12 and 24 months after seton drain removal

  6. 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

    Measured: 6, 12 and 24 months after seton drain removal

  7. Change in discomfort and impact assessed by the patient using a visual analog scale (VAS)

    Measured: 3, 6, 12 and 24 months after seton drain removal

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jul 2011 (estimated)
  2. Study startOct 2011
  3. Primary completionMar 2016 (estimated)
  4. Study completionMar 2017 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
180 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01388257
Sponsor's protocol ID
SNFCP-001
Acronym
FACC
Status last verified
Jun 2012
First submitted
4 Jul 2011
Last updated
7 Jun 2012
Results posted
No
Data monitoring committee
No

Publications

  • Abramowitz L, Brochard C, Pigot F, Roumeguere P, Pillant H, Vinson Bonnet B, Faucheron JL, Senejoux A, Bonnaud G, Meurette G, Fayette JM, Train C, Staumont G, Siproudhis L, Bouchard D. Surgical closure, mainly with glue injection and anti-tumour necrosis factor alpha, in fistulizing perianal Crohn's disease: A multicentre randomized controlled trial. Colorectal Dis. 2022 Feb;24(2):210-219. doi: 10.1111/codi.15947. Epub 2021 Oct 23.

    PubMed 34623746

Questions about this trial

What is this clinical trial studying?

A study testing All types of surgery procedures and Simple seton drain removal in people with Crohn Disease and Fistula, run by French Society of Coloproctology at 15 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 7 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Laurent Abramowitz, MD (140 50 11 22 ext. +33, laurent.abramowitz@bch.ap-hop-paris.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of patients having a clinical healing of their anoperineal fistulas in Crohn disease (time frame: 12 months after seton drain removal). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01388257, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2012.

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