Pilot-study of OSCAR ENDO One Stop Assessment of Risk for Endometrial Hyperplasia and Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- A negative predictive value of 99 %
研究概览
简要总结
It is to be achieved that in postmenopausal women through the combination of Hysteroscopy and intraoperative rapid section a positive predictive value (PPV) regarding the objective illness like endometrial cancer or adenomatous hyperplasia of 100% so as a negative predictive value (NPV) of 99%.
详细描述
If a patient fulfills the inclusion criteria, the surgeon decides intraoperatively due to the aspect in the hysteroscopy if it is a clearly benign result or if it looks suspicious or malign.
In case of a hysteroscopical benign result the patient will be informed about the result after the operation.
In case of a hysteroscopal suspicious or malignant aspect, the curettement will be sent for a rapid section. If the hysteroscopic result confirms the hysteroscopic suspicion the patient will be informed after the operation and the further treatment can be planned right away.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Postmenopausal status (more than 1 year of last menopausal bleeding)
- •Postmenopausal vaginal bleeding
- •Asymptomatic postmenopausal endometrial hyperplasia
- •Understanding of the german language
- •Signature and consent of the patient
排除标准
- •Not able to understand and participate in the study
- •Premenopausal status
- •no informed consent
结局指标
主要结局
A negative predictive value of 99 %
时间窗: Intraoperative
To get in combination of hysteroscopy and rapid section of the endometrial curettement a negative predictive value of 99% as well as a positive predictive value of 100%.
次要结局
未报告次要终点