NCT07031050已完成不适用
Robotic Sacrocolpopexy and Sacrocervicopexy - an Observational Study to Confirm the Peri- and Postoperative Safety and Clinical Performance
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 9
- 主要终点
- Primary safety outcome
研究概览
简要总结
This study aims to confirm the perioperative and early postoperative safety and clinical performance (efficacy) of the Dexter Robotic System, in patients undergoing robotic-assisted sacrocolpopexy or sacrocervicopexy.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged > 18 years
- •Women with symptomatic stage I or greater pelvic organ prolapse (POP-Q)
- •Patient agrees to perform the 6-week follow-up assessment as per Standard of Care
排除标准
- •Any planned non-urogynaecological concomitant procedures
- •History of previous POP surgery, with the exception of transvaginal approaches without mesh implantation
- •Previous surgery and/or radiation for urologic, gastrointestinal or gynecologic cancer
- •History of Crohn's disease
- •Chronic colitis
结局指标
主要结局
Primary safety outcome
时间窗: up to 42 days after surgery
Occurrence of Clavien-Dindo grades III-V adverse events
Primary efficacy outcome
时间窗: Intraoperative
Successful completion of the Dexter-assisted procedure, i.e. free of any conversion to an open or fully laparoscopic surgical approach
次要结局
未报告次要终点
研究者
研究点 (9)
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