Single Versus Multi-port Robotic Assisted Sacrocolpopexy for Repair of Vaginal Apex Prolapse
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Comparison of surgical time
研究概览
简要总结
A prospective randomized controlled study intended to compare the efficacy of 2 methods of robotic assisted sacrocolpopexy for the repair of vaginal apex prolapse:
- Via single-port.
- Via multi-port.
详细描述
One hundred female patients diagnosed with vaginal apex prolapse will be recruited to a prospective randomized controlled study intended to compare the efficacy of 2 methods of robotic assisted sacrocolpopexy:
- Via single-port.
- Via multi-port. The patients will be evaluated and randomized 2 weeks before the expected date of surgery during which eligibility will be examined.
Patients' electronic files will be reviewed post operatively to acquire information regarding medical history, prolapse scores, surgical information, anesthesia information and surgical complications.
Patients will have 3 week and 3 month post operative follow-up sessions to determine surgical success, late complications and patient satisfaction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients with vaginal apex prolapse that are eligible for repair by sacrocolpopexy.
排除标准
- •Patients after previous hysterectomy.
- •Patients after previous surgical procedures for prolapse repair.
研究组 & 干预措施
Single-port sacrocolpopexy
Patients with vaginal apex prolapse randomized to undergo repair by single-port sacrocolpopexy.
干预措施: Single-port sacrocolpopexy (Procedure)
Multi-port sacrocolpopexy
Patients with vaginal apex prolapse randomized to undergo repair by multi- port sacrocolpopexy.
干预措施: Multi-port sacrocolpopexy (Procedure)
结局指标
主要结局
Comparison of surgical time
时间窗: Up to four months (2 weeks before surgery until 3 months post-surgery).
Comparison of surgical time in single versus multi-port robotic assisted sacrocolpopexy.
次要结局
- Comparison of surgical success(Up to four months (2 weeks before surgery until 3 months post-surgery).)
- Comparison of surgical complications(Up to four months (2 weeks before surgery until 3 months post-surgery).)
研究者
ROY LAUTERBACH MD
Principal investigator
Rambam Health Care Campus