Randomized Double Blind Controlled Trial of the Value of Robotic Rectopexy for the Treatment of Complex Pelvic Floor Dysfunction
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Perioperative outcomes
研究概览
简要总结
The purpose of this randomized double blind controlled study is to assess the value of robotics for the treatment of complex pelvic floor dysfunction. The main aim is to compare perioperative and functional outcomes to the laparoscopic approach.
详细描述
Pelvic floor dysfunction is a common pathology. The management can be medical or surgical, depending on the location or the severity of the disease.
Since the large use of laparoscopy for the treatment of pelvic floor dysfunction, interesting and encouraging results have been published.
However, so far, a laparoscopic approach has some technical disadvantages like a poor ergonomy, a 2 dimensional vision, an unstable camera and the use of straight instruments. To overcome these natural limitations, robotics has been gaining increasing acceptance in general surgery.
Several groups have reported their encouraging experience with robotic rectopexy. Yet, these studies were not randomized or double blinded.
The aim of this study is to evaluate the role of robotics for complex pelvic floor dysfunction and to compare the outcomes to the laparoscopic approach.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •proven pelvic floor dysfunction
- •informed consent
排除标准
- •Age <18 years old
- •Patient unable to communicate or to understand the study
- •Patient refusing to participate to the study
- •contraindication to laparoscopy
研究组 & 干预措施
Robotic
Use of daVinci surgical system (Intuitive Surgical Inc, Sunnyvale, CA) for the treatment of complex pelvic floor dysfunction
干预措施: Minimally invasive rectopexy (Procedure)
Laparoscopy
Use of standard laparoscopy for the treatment of complex pelvic floor dysfunction
干预措施: Minimally invasive rectopexy (Procedure)
结局指标
主要结局
Perioperative outcomes
时间窗: up to 30 days
Including: blood loss, operative time, conversion rate, quality of dissection, pain, complications, hospital stay.
次要结局
- Functional results(At 12 months)
研究者
Nicolas C. Buchs
Faculty surgeon
University Hospital, Geneva
