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

Study Overview
=================
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.

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

Conditions
-----------------
Rectal Prolapse, Pelvic Organ Prolapse

Intervention / Treatment
-----------------
* Procedure: Minimally invasive rectopexy


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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