Overview

This trial is active, not recruiting.

Condition endometriosis
Treatment various surgical procedures in endometriosis
Sponsor University Hospital, Rouen
Collaborator University Hospital, Lille
Start date June 2009
End date June 2017
Trial size 1500 participants
Trial identifier NCT02294825, 2009-099-HP

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Primary Outcomes

Measure
Recurrences
time frame: 7 years

Secondary Outcomes

Measure
Risk factors for endometriosis
time frame: 1 year
Digestive functional outcomes
time frame: 7 years
Fertility
time frame: 7 years

Eligibility Criteria

Female participants from 18 years up to 50 years old.

Inclusion Criteria: - Endometriosis revealed on histological specimens Exclusion Criteria:

Additional Information

Official title The North-West Inter Regional Female Cohort for Patients With Endometriosi
Principal investigator Horace Roman
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).
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by University Hospital, Rouen.