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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")


N/A
18 Years
N/A
Open (Enrolling)
Both
Crohn Disease, Fistula, Anoperineal Fistula, Anal Fistula

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Trial Information

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")


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

12 months after seton drain removal

Safety Issue:

No

Principal Investigator

Laurent Abramowitz, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Hôpital Bichat-Claude Bernard

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

SNFCP-001

NCT ID:

NCT01388257

Start Date:

October 2011

Completion Date:

March 2017

Related Keywords:

  • Crohn Disease
  • Fistula
  • Anoperineal Fistula
  • Anal Fistula
  • Crohn Disease
  • Anoperineal fistula
  • Anal fistula
  • Proctology
  • Drainage
  • Colorectal Surgery
  • Fistulotomy
  • Plug
  • Advancement flap
  • Glue
  • Anti Tumor Necrosis Factor-alpha
  • Adalimumab
  • Crohn Disease
  • Fistula
  • Rectal Fistula

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