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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
180
All types of surgery procedures used for anoperineal fistula repair. Surgery procedures include fistulotomy, biological glue, rectal advancement flap and plug.
Patients are simply followed after seton drain removal.
CHU Bordeaux - Hôpital Saint André - Department of Hepato Gastroenterology
Bordeaux, Aquitaine, France
Percentage of patients having a clinical healing of their anoperineal fistulas in Crohn disease
Time frame: 12 months after seton drain removal
Proportion of patients having more than half of their fistulas healed
Time frame: 3, 6, 12 and 24 months after seton drain removal
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
Change in anal continence assessed by Wexner and Vaizey scores
Time frame: 12 and 24 months after seton drain removal
Crohn's Disease Endoscopic Index of Severity (CDEIS)
Time frame: 12 months after seton drain removal
Change in patients' quality of life, assessed by the Inflammatory Bowel Disease Questionnaire (IBDQ)
Time frame: 12 and 24 months after seton drain removal
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
Time frame: 6, 12 and 24 months after seton drain removal
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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Maison de Santé Protestante de Bordeaux Bagatelle - Department of Proctology
Talence, Aquitaine, France
RECRUITINGClinique universitaire de chirurgie Digestive et de l'urgence, Hopital Universitaire Michallon - Colorectal Surgery Unit
Grenoble, Auvergne-Rhône-Alpes, France
RECRUITINGCHU Pontchaillou - Department of Digestive Diseases
Rennes, Brittany Region, France
NOT_YET_RECRUITINGPolyclinique de Franche-Comté - Department of Proctological Surgery
Besançon, Franche-Comté, France
NOT_YET_RECRUITINGCHU de Rouen - Departement of Hepato Gastroenterologie and Nutrition
Rouen, Haute Normandie, France
NOT_YET_RECRUITINGClinique des Cèdres - Hepato-Gastroenterology Department
Cornebarrieu, Midi-Pyrénées, France
RECRUITINGClinique Saint Jean Languedoc - Department of Gastroenterology
Toulouse, Midi-Pyrénées, France
NOT_YET_RECRUITINGHôpital Nord de Marseille - Gastroenterology Department
Marseille, France
NOT_YET_RECRUITINGHôpital de POISSY
Poissy, France
NOT_YET_RECRUITING...and 5 more locations