NCT03634878已完成不适用
Evaluation of the Position of Promontofixation Prostheses in Perineal Ultrasound
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Evaluate the reproducibility study of intra and interobserver measurements of the size of promontofixation prostheses
研究概览
简要总结
Indirect promontofixation with prostheses is the standard surgical technique for the reference of uterine prolapse. There is no validated examination to control the position of the prostheses postoperatively.
These prostheses are echogenic and perineal ultrasound could be a means of postoperative monitoring. There is no data in the literature on the relationship between prosthesis position and postoperative symptoms
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years of female sex
- •Patient with double laparoscopic promontofixation without associated hysterectomy
排除标准
- •History of hysterectomy
- •Anterior cure (before index intervention) of prolapse with placement of prosthetic material.
结局指标
主要结局
Evaluate the reproducibility study of intra and interobserver measurements of the size of promontofixation prostheses
时间窗: 10 minutes
Evaluate the reproducibility study of intra and interobserver measurements position of promontofixation prostheses
时间窗: 20 minutes
次要结局
- Collect the position of the strips(20 minutes)
- Collect the symptoms of the patients(20 minutes)
研究者
研究点 (2)
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