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

• Conditions: Endometriosis

• Registration Number: NCT02294825
• Lead Sponsor: University Hospital, Rouen

Brief 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).

Study Timeline

• Study Start: 2009-06
• Study First Submitted: 2014-11-16
• Study First Submitted QC: 2014-11-16
• Study First Posted: 2014-11-19
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-23
• Last Update Posted: 2019-10-24
• Primary Completion: 2022-06
• Study Completion: 2022-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 1500

Inclusion Criteria

• Endometriosis revealed on histological specimens

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Recurrences	7 years	rate of recurrences at 1,3,5 and 7 years postoperatively

Secondary Outcome Measures

Name	Time	Method
Risk factors for endometriosis	1 year	Association of various antecedents with specific localizations of features of the endometriosis
Digestive functional outcomes	7 years	Bowel function in patients managed for bowel endometriosis by various procedures
Fertility	7 years	Rate of pregnancy at 1, 3, 5, and 7 years postoperatively

Trial Locations

Locations (1)

Clinique Gynécologique et Obstétricale; 🇫🇷 Rouen, France