Anal Crohn Fistula Surgery (FACC)
This study is currently recruiting participants.
Verified June 2012 by French Society of Coloproctology
Sponsor:
French Society of Coloproctology
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
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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:
Genetics Home Reference related topics:
Crohn disease
Drug Information available for:
Adalimumab
U.S. FDA Resources
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
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 | |
| 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 | |
| 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 | |
| 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:
SNFCP website 
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:
|
Crohn Disease Anoperineal fistula Anal fistula Proctology Drainage Colorectal Surgery |
Fistulotomy Plug Advancement flap Glue Anti Tumor Necrosis Factor-alpha Adalimumab |
Additional relevant MeSH terms:
|
Crohn Disease Fistula Rectal Fistula Inflammatory Bowel Diseases Gastroenteritis Gastrointestinal Diseases Digestive System Diseases Intestinal Diseases Pathological Conditions, Anatomical |
Intestinal Fistula Digestive System Fistula Rectal Diseases Adalimumab Antirheumatic Agents Therapeutic Uses Pharmacologic Actions Anti-Inflammatory Agents |
ClinicalTrials.gov processed this record on May 16, 2013