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

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.

Study Overview

• Status: Unknown
• Conditions: Pelvic Organ Prolapse; Rectal Prolapse
• Intervention / Treatment: Procedure: Minimally invasive rectopexy

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 Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Nicolas C Buchs, MD; Phone Number: +41 79 553 2683; Email: nicolas.c.buchs@hcuge.ch

Study Locations

• Switzerland
  • Geneva, Switzerland, 1211
    • Recruiting
    • University Hospital of Geneva, Department of Surgery
    • Contact: Nicolas C Buchs, MD; Phone Number: +41 553 2683; Email: nicolas.c.buchs@hcuge.ch
    • Principal Investigator: Nicolas C Buchs, MD
    • Sub-Investigator: Bruno Roche, MD
    • Sub-Investigator: François Pugin, MD
    • Sub-Investigator: Pascal Bucher, MD
    • Sub-Investigator: Karel Skala, MD
    • Sub-Investigator: Frédéric Ris, MD
    • Sub-Investigator: Monika Hagen, MD
    • Sub-Investigator: Guillaume Zufferey, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Robotic; Use of daVinci surgical system (Intuitive Surgical Inc, Sunnyvale, CA) for the treatment of complex pelvic floor dysfunction	Procedure: Minimally invasive rectopexy; Use of a minimally invasive approach (robotic or laparoscopy) to perform a rectopexy; Other Names: Surgery for rectal prolapse
Active Comparator: Laparoscopy; Use of standard laparoscopy for the treatment of complex pelvic floor dysfunction	Procedure: Minimally invasive rectopexy; Use of a minimally invasive approach (robotic or laparoscopy) to perform a rectopexy; Other Names: Surgery for rectal prolapse

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional results	Constipation score Incontinence score Quality of life score Sexuality score	At 12 months

Collaborators and Investigators

• Sponsor: Nicolas C. Buchs
• Investigators: Principal Investigator: Nicolas C Buchs, MD, University Hospital, Geneva

Study record dates

Study Major Dates

• Study Start: April 1, 2011
• Primary Completion (Anticipated): May 1, 2020
• Study Completion (Anticipated): May 1, 2020

Study Registration Dates

• First Submitted: April 29, 2011
• First Submitted That Met QC Criteria: April 29, 2011
• First Posted (Estimate): May 3, 2011

Study Record Updates

• Last Update Posted (Actual): May 5, 2017
• Last Update Submitted That Met QC Criteria: May 4, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Pathological Conditions, Anatomical; Rectal Diseases; Prolapse; Pelvic Organ Prolapse; Rectal Prolapse
• Other Study ID Numbers: CER-11-047