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

Pelvic Organ Prolapse Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01346436
• Other study ID #: CER-11-047
• Status: Recruiting
• Phase: Phase 4
• First received: April 29, 2011
• Last updated: May 4, 2017
• Start date: April 2011
• Est. completion date: May 2020

Study information

• Verified date: May 2017
• Source: University Hospital, Geneva
• Contact: Nicolas C Buchs, MD
• Phone: +41 79 553 2683
• Email: nicolas.c.buchs[@]hcuge.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: May 2020
• Est. primary completion date: May 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pelvic Organ Prolapse
• Prolapse
• Rectal Prolapse

Intervention

Procedure:
• Minimally invasive rectopexy
Use of a minimally invasive approach (robotic or laparoscopy) to perform a rectopexy

Locations

Country	Name	City	State
Switzerland	University Hospital of Geneva, Department of Surgery	Geneva

Sponsors (1)

Lead Sponsor	Collaborator
Nicolas C. Buchs

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Perioperative outcomes	Including: blood loss, operative time, conversion rate, quality of dissection, pain, complications, hospital stay.	up to 30 days
Secondary	Functional results	Constipation score Incontinence score Quality of life score Sexuality score	At 12 months