NCT02294825

The North-West Inter Regional Female Cohort for Patients With Endometriosis

The North-West Inter Regional Female Cohort for Patients With Endometriosi

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 1,500 (estimated)
• Sponsor: University Hospital, Rouen · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

All women managed for endometriosis are included and followed up through the CIRENDO database. Information is obtained from surgical and histological records and from self-questionnaires completed before surgery. Standardized gastrointestinal questionnaires (KESS, GIQLI, WEXNER, FIQL and Bristol) are routinely used to assess bowel function. Data recording, patient contact and follow-up are carried out by a clinical research technician. Postoperative follow-up is based on data from the afore-mentioned questionnaires completed at 1, 3, 5 and 7 years.

Detailed description

All women managed for endometriosis are included and followed up through the CIRENDO database (the North-West Inter Regional Female Cohort for Patients with Endometriosis), a prospective cohort financed by the G4 Group (The University Hospitals of Rouen, Lille, Amiens and Caen), and coordinated by the principal investigator (H.R.). Information is obtained from surgical and histological records and from self-questionnaires completed before surgery. Standardized gastrointestinal questionnaires (KESS, GIQLI, WEXNER, FIQL and Bristol) are routinely used to assess bowel function. Data recording, patient contact and follow-up are carried out by a clinical research technician. Women are included in the CIRENDO database only when endometriosis is confirmed by both surgical exploration and biopsy. Postoperative follow-up is based on data from the afore-mentioned questionnaires completed at 1, 3, 5 and 7 years. Prospective data recording and analysis were approved by the French authorities CNIL (Commission Nationale de l'Informatique et des Libertés) and CCTIRS (Comité Consultatif pour le Traitement de l'Information en matière de Recherche dans le domaine de la Santé).

Conditions

• Endometriosis

Interventions

Type	Name	Description
PROCEDURE	various surgical procedures in endometriosis	Shaving, disc excision and colorectal resection; ureterolysis or ureter resection; bladder resection; ablation of endometriomas using plasma energy; excision and ablation of deep and superficial lesions

Timeline

• Start date: 2009-06-01
• Primary completion: 2022-06-01
• Completion: 2022-06-01
• First posted: 2014-11-19
• Last updated: 2019-10-24

Locations

1 site across 1 country: France