NCT01346436

Value of Robotic Rectopexy for the Treatment of Complex Pelvic Floor Dysfunction

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Nicolas C. Buchs · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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 description

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.

Conditions

• Rectal Prolapse
• Pelvic Organ Prolapse

Interventions

Type	Name	Description
PROCEDURE	Minimally invasive rectopexy	Use of a minimally invasive approach (robotic or laparoscopy) to perform a rectopexy

Timeline

• Start date: 2011-04-01
• Primary completion: 2020-05-01
• Completion: 2020-05-01
• First posted: 2011-05-03
• Last updated: 2017-05-05

Locations

1 site across 1 country: Switzerland