Cohort of the Franco-European Multidisciplinary Institute of Endometriosis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 15,000
- 试验地点
- 1
- 主要终点
- Efficacity of differents treatments
研究概览
简要总结
Endometriosis is a chronic benign gynecological condition affecting 5 to 10% of women of reproductive age, often responsible for pelvic pain, digestive symptoms, and infertility, leading to a significant reduction in quality of life. Despite its high prevalence, the long-term outcomes of different medical and surgical treatments remain poorly documented.
The IFEMENDO study is a prospective, observational, single-center, non-interventional cohort conducted at the Endometriosis Center of Clinique Tivoli-Ducos in Bordeaux, France. The objective is to evaluate the long-term efficacy of various therapeutic strategies-both medical and surgical-in terms of symptom improvement, quality of life, recurrence, and fertility outcomes.
Women with histologically or radiologically confirmed pelvic endometriosis are invited to participate. Data are collected through standardized questionnaires at baseline and at 1, 3, 5, 7, and 10 years after inclusion, either via the secure NO ENDO online platform or in paper form. The study will contribute to a better understanding of the natural history of endometriosis and the long-term effectiveness of different treatment approaches, ultimately supporting improvements in clinical management and patient care.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged >18 years
- •Women with histologically or radiologically confirmed deep endometriosis (and/or) infiltrating the colon and/or rectum
- •Women affiliated with the social security system
排除标准
- •Refusal to participate
- •Patients under guardianship or curatorship, or deprived of liberty
结局指标
主要结局
Efficacity of differents treatments
时间窗: Each patient fills out the questionnaires at inclusion, and then at 1 year, 3 years, 5 years, 7 years, and 10 years.
The primary objective is to study the long-term efficacy of different treatments, both drug and surgical, in terms of taux de grossesse : the proportion of patients who achieved a pregnancy during follow-up (unit: percentage).
次要结局
- Evaluation of digestive function(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(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(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(Each patient fills out the questionnaires at inclusion, and then at 1 year, 3 years, 5 years, 7 years, and 10 years.)