Clinical Trial: Value of Robotic Rectopexy for the Treatment of Complex Pelvic Floor Dysfunction

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

Brief Summary: 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.

Detailed Summary:

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.

Sponsor: Nicolas C. Buchs

Current Primary Outcome: Perioperative outcomes [ Time Frame: up to 30 days ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Functional results [ Time Frame: At 12 months ]

Original Secondary Outcome: Same as current

Information By: University Hospital, Geneva

Dates:
Date Received: April 29, 2011
Date Started: April 2011
Date Completion: May 2020
Last Updated: May 4, 2017
Last Verified: May 2017