NCT01388257

Anal Crohn Fistula Surgery

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")

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 180 (estimated)
• Sponsor: French Society of Coloproctology · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Crohn Disease
• Fistula
• Anoperineal Fistula
• Anal Fistula

Interventions

Type	Name	Description
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.
PROCEDURE	Simple seton drain removal	Patients are simply followed after seton drain removal.

Timeline

• Start date: 2011-10-01
• Primary completion: 2016-03-01
• Completion: 2017-03-01
• First posted: 2011-07-06
• Last updated: 2012-06-07

Locations

15 sites across 1 country: France