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Clinical Trials/NCT02294825
NCT02294825UnknownNot Applicable

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

University Hospital, Rouen1 site in 1 country1,500 target enrollmentStarted: June 2009Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
1,500
Locations
1
Primary Endpoint
Recurrences

Study Overview

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 Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 50 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Endometriosis revealed on histological specimens

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Recurrences

Time Frame: 7 years

rate of recurrences at 1,3,5 and 7 years postoperatively

Secondary Outcomes

  • Risk factors for endometriosis(1 year)
  • Digestive functional outcomes(7 years)
  • Fertility(7 years)

Investigators

Sponsor
University Hospital, Rouen
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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