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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
50
Use of a minimally invasive approach (robotic or laparoscopy) to perform a rectopexy
University Hospital of Geneva, Department of Surgery
Geneva, Switzerland
RECRUITINGPerioperative outcomes
Including: blood loss, operative time, conversion rate, quality of dissection, pain, complications, hospital stay.
Time frame: up to 30 days
Functional results
Constipation score Incontinence score Quality of life score Sexuality score
Time frame: At 12 months
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