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

Phase 4

• Conditions: Rectal Prolapse; Pelvic Organ Prolapse
• Interventions: Procedure: Minimally invasive rectopexy

• Registration Number: NCT01346436
• Lead Sponsor: Nicolas C. Buchs

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 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.

Study Timeline

• Study Start: 2011-04
• Study First Submitted: 2011-04-29
• Study First Submitted QC: 2011-04-29
• Study First Posted: 2011-05-03
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-04
• Last Update Posted: 2017-05-05
• Primary Completion: 2020-05
• Study Completion: 2020-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 50

Inclusion Criteria

• women
• proven pelvic floor dysfunction
• informed consent

Exclusion Criteria

• Age <18 years old
• Patient unable to communicate or to understand the study
• Patient refusing to participate to the study
• contraindication to laparoscopy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Robotic	Minimally invasive rectopexy	Use of daVinci surgical system (Intuitive Surgical Inc, Sunnyvale, CA) for the treatment of complex pelvic floor dysfunction
Laparoscopy	Minimally invasive rectopexy	Use of standard laparoscopy for the treatment of complex pelvic floor dysfunction

Primary Outcome Measures

Name	Time	Method
Perioperative outcomes	up to 30 days	Including: blood loss, operative time, conversion rate, quality of dissection, pain, complications, hospital stay.

Secondary Outcome Measures

Name	Time	Method
Functional results	At 12 months	Constipation score Incontinence score Quality of life score Sexuality score

Trial Locations

Locations (1)

University Hospital of Geneva, Department of Surgery; 🇨🇭 Geneva, Switzerland