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临床试验/NCT01346436
NCT01346436Unknown4 期

Randomized Double Blind Controlled Trial of the Value of Robotic Rectopexy for the Treatment of Complex Pelvic Floor Dysfunction

Nicolas C. Buchs1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2011年4月1日最近更新:
适应症
干预措施

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

Active Comparator

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

Active Comparator

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

发起方
Nicolas C. Buchs
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Nicolas C. Buchs

Faculty surgeon

University Hospital, Geneva

研究点 (1)

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