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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01346436
Other study ID # CER-11-047
Secondary ID
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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