Prevention of Adhesions During Celioscopy for Endometriosis. Impact of the Use of Anti-adhesion Treatment on Clinical Signs and Fertility at One Year
试验速览
- 阶段
- 不适用
- 入组人数
- 364
- 试验地点
- 1
- 主要终点
- Fertility
研究概览
简要总结
Thus is a longitudinal, prospective, multicentric observational study performed in mainland France, among a sample of gynaecology surgeons practising at endometriosis "expert" centres.
The aim of this study is to describe, under real treatment conditions in patients suffering from endometriosis, the impact of the use of anti-adhesion treatment during celioscopy surgery on the development of clinical signs in the patients and their fertility at one year.
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
- •Adult patients of procreation age and who have undergone treatment for endometriosis through celioscopic surgery.
- •Patients for whom spontaneous pregnancy is possible, whether or not they wish to become pregnant immediately.
- •Patients accepting and able to update a questionnaire in French.
- •Informed patients who agree to computerised processing of their medical data and their right of access and rectification.
排除标准
- •Patients for whom a medical assistance programme for procreation (IVF, artificial insemination) is currently in progress.
- •Patients presenting with an absolute or relative contra-indication for use of an anti-adhesion agent (severe allergic antecedents etc).
- •Patients not wishing to become pregnant.
- •Patients participating or having participated during the previous month in a gynaecological clinical trial.
结局指标
主要结局
Fertility
时间窗: One year after the baseline visit (i.e. celioscopy)
rate of pregnancy women
Change on the clinical signs
时间窗: At 2 months and one year after the baseline visit (i.e. celioscopy)
The clinical change will be established after one year via the pain symptomatology reported by the patient, the rate of relapse (re-hospitalisation) and the rate of any eventual complications from the celioscopy (adhesions, etc.).
次要结局
未报告次要终点