Ultrasound Evaluation of the Pelvis Using the International Deep Endometriosis Analysis (IDEA) Terminology in Women with Suspected Endometriosis Scheduled for Laparoscopic Surgery - IDEA 1 Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,866
- 试验地点
- 3
- 主要终点
- Presence of deep endometriosis
研究概览
简要总结
An international multicenter observation study to evaluate the diagnostic accuracy and predictive value of ultrasound using the IDEA terminology in the detection of deep endometriosis in women scheduled for surgery.
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 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled for radical laparoscopic endometriosis surgery
排除标准
- •<18 years
- •>45 years
- •(suspected) Pelvic malignancy for example gynecological, intestinal or urological malignancy
- •Premenarche
- •Menopause
- •Pregnancy
- •Patients refusal for radical surgery (for example refusal for bowel resection/temporary stoma)
- •Surgery performed more than 1 year after ultrasound scan
- •Patients refusal to participate to the study
结局指标
主要结局
Presence of deep endometriosis
时间窗: 1 year
The primary objective is to assess the diagnostic value of the ultrasound features in the diagnosis of deep endometriosis. The endpoints are the univariable diagnostic accuracies of ultrasound features (defined by the IDEA consensus statement) for the presence of deep endometriosis at any location: anterior compartment (i.e. bladder and its specific location) or posterior compartment (i.e. rectovaginal septum, uterosacral ligaments, torus uterinus, vaginal fornix and bowel involvement). All recruited patients are included in this analysis. The reference standard for this objective is whether there is deep endometriosis (at any location) or not (binary outcome).
次要结局
未报告次要终点