Informations générales (source: ClinicalTrials.gov)
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") (FACC)
Interventional
N/A
French Society of Coloproctology (Voir sur ClinicalTrials)
octobre 2011
mars 2017
29 juin 2024
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.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CHI POISSY ST-GERMAIN | Béatrice VINSON-BONNET, MD | Contact (sur clinicalTrials) | |||
| GH PARIS SITE SAINT JOSEPH | Sénéjoux | Contact (sur clinicalTrials) | |||
| IFSI DE L'HÔPITAL LOUIS MOURIER | Coffin | Contact (sur clinicalTrials) | |||
| IFSI-IFAS DU CH BICHAT-CLAUDE BERNARD | Laurent Abramowitz, MD | Contact (sur clinicalTrials) | |||
| INSTITUT MUTUALISTE MONTSOURIS | Godeberge | Contact (sur clinicalTrials) | |||
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| CHU Bordeaux - Hôpital Saint André - Department of Hepato Gastroenterology - 33075 - Bordeaux - Aquitaine - France | Roumeguère-Blond | Contact (sur clinicalTrials) | |||
| CHU de Rouen - Departement of Hepato Gastroenterologie and Nutrition - 76031 - Rouen - Haute Normandie - France | Savoye | Contact (sur clinicalTrials) | |||
| Clinique Saint Jean Languedoc - Department of Gastroenterology - 31077 - Toulouse - Midi-Pyrénées - France | Staumont | Contact (sur clinicalTrials) | |||
| Hôpital Nord de Marseille - Gastroenterology Department - 13915 - Marseille - France | Jean-Charles GRIMAUD, MD | Contact (sur clinicalTrials) | |||
| Polyclinique de l'Océan - 44600 - Saint-Nazaire - France | Florent JURCZAK, MD | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| CHU Pontchaillou - Department of Digestive Diseases - 35033 - Rennes - Bretagne - France | Siproudhis | Contact (sur clinicalTrials) | |||
| Clinique des Cèdres - Hepato-Gastroenterology Department - 31700 - Cornebarrieu - Midi-Pyrénées - France | Bonnaud | Contact (sur clinicalTrials) | |||
| Clinique universitaire de chirurgie Digestive et de l'urgence, Hopital Universitaire Michallon - Colorectal Surgery Unit - 38043 - Grenoble - Rhône-Alpes - France | Faucheron | Contact (sur clinicalTrials) | |||
| Maison de Santé Protestante de Bordeaux Bagatelle - Department of Proctology - 33401 - Talence - Aquitaine - France | Bouchard | Contact (sur clinicalTrials) | |||
| Polyclinique de Franche-Comté - Department of Proctological Surgery - 25052 - Besançon - Franche-Comté - France | Fantoli | Contact (sur clinicalTrials) | |||
Critères
Tous
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.
- 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.
- 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.