Cohort of the Franco-European Multidisciplinary Institute of Endometriosis

Detailed Description

The IFEMENDO study is an observational, single-center, non-interventional, prospective cohort conducted at the Endometriosis Center of Clinique Tivoli-Ducos in Bordeaux, France. The study aims to evaluate the long-term efficacy of various medical and surgical treatments for deep pelvic endometriosis in terms of symptom improvement, quality of life, recurrence rate, and fertility outcomes.

Endometriosis is a benign but chronic gynecological condition affecting 5 to 10% of women of reproductive age, most of whom are professionally active. It can cause pelvic pain of varying duration and intensity, digestive dysfunction, and infertility, leading to significant deterioration in quality of life and social well-being. Diagnosis is often delayed for several years after symptom onset, which explains the high prevalence of advanced stages and deep localizations at the time of diagnosis. Despite its frequency, the natural history of endometriosis and long-term outcomes after treatment remain poorly documented. Existing studies are mostly randomized trials with small sample sizes or retrospective series from single surgical teams, with follow-up rarely exceeding two or three years.

This study will include all women with histologically or radiologically confirmed pelvic endometriosis seen in consultation or operated on at the Endometriosis Center. After obtaining non-opposition consent, each participant will complete a baseline questionnaire including medical and surgical history, endometriosis-related symptoms, fertility status, and quality of life. In the case of surgery, the surgeon will complete a detailed form describing disease localization, surgical procedures performed, and any postoperative complications.

Participants will then be invited to complete follow-up questionnaires at 1, 3, 5, 7, and 10 years after inclusion. These follow-up questionnaires will cover the same domains: symptoms, fertility, and quality of life. Data will be collected through the secure NO ENDO online platform or, if preferred, on paper forms later transcribed into the electronic database by trained clinical research associates.

Registry Procedures and Quality Assurance

A quality assurance plan has been implemented to ensure the validity, reliability, and completeness of data collected in the registry. Data validation procedures include automated range and consistency checks at the time of data entry, as well as periodic manual reviews. Source data verification will be performed by comparing data entered in the NO ENDO system against medical records and operative reports.

Standard Operating Procedures are in place to guide all registry activities, including patient recruitment, informed consent documentation, data entry and management, monitoring, adverse event reporting, and database updates. The registry complies with French data protection regulations and the European General Data Protection Regulation.

Sample Size and Data Management

All eligible women consulting at the Endometriosis Center and meeting inclusion criteria will be invited to participate. The expected cohort size is several thousand patients, allowing robust statistical analyses over a 10-year follow-up period.

• Evaluation of digestive function [Time frame: Each patient fills out the questionnaires at inclusion, and then at 1 year, 3 years, 5 years, 7 years, and 10 years.]
• Evaluation of the probability of pregnancy [Time frame: Each patient fills out the questionnaires at inclusion, and then at 1 year, 3 years, 5 years, 7 years, and 10 years.]
• Evaluation of the risk factor [Time frame: Each patient fills out the questionnaires at inclusion, and then at 1 year, 3 years, 5 years, 7 years, and 10 years.]
• Evaluation of evolution of endometriosis [Time frame: Each patient fills out the questionnaires at inclusion, and then at 1 year, 3 years, 5 years, 7 years, and 10 years.]