Viewing Study NCT02294825



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Last Modification Date: 2024-10-26 @ 11:34 AM
Study NCT ID: NCT02294825
Status: UNKNOWN
Last Update Posted: 2019-10-24
First Post: 2014-11-16

Brief Title: The North-West Inter Regional Female Cohort for Patients With Endometriosis
Sponsor: University Hospital Rouen
Organization: University Hospital Rouen

Study Overview

Official Title: The North-West Inter Regional Female Cohort for Patients With Endometriosi
Status: UNKNOWN
Status Verified Date: 2019-10
Last Known Status: RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: CIRENDO
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 HR 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 lInformatique et des Libertés and CCTIRS Comité Consultatif pour le Traitement de lInformation en matière de Recherche dans le domaine de la Santé

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None