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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2014 by University Hospital, Geneva
Sponsor:
Information provided by (Responsible Party):
Nicolas C. Buchs, University Hospital, Geneva
ClinicalTrials.gov Identifier:
NCT01346436
First received: April 29, 2011
Last updated: December 1, 2014
Last verified: December 2014
  Purpose

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.


Condition Intervention Phase
Rectal Prolapse
Pelvic Organ Prolapse
Procedure: Minimally invasive rectopexy
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Double Blind Controlled Trial of the Value of Robotic Rectopexy for the Treatment of Complex Pelvic Floor Dysfunction

Resource links provided by NLM:


Further study details as provided by University Hospital, Geneva:

Primary Outcome Measures:
  • Perioperative outcomes [ Time Frame: up to 30 days ] [ Designated as safety issue: Yes ]
    Including: blood loss, operative time, conversion rate, quality of dissection, pain, complications, hospital stay.


Secondary Outcome Measures:
  • Functional results [ Time Frame: At 12 months ] [ Designated as safety issue: No ]
    Constipation score Incontinence score Quality of life score Sexuality score


Estimated Enrollment: 50
Study Start Date: April 2011
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Surgery for rectal prolapse

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01346436

Contacts
Contact: Nicolas C Buchs, MD +41 79 553 2683 nicolas.c.buchs@hcuge.ch

Locations
Switzerland
University Hospital of Geneva, Department of Surgery Recruiting
Geneva, Switzerland, 1211
Contact: Nicolas C Buchs, MD    +41 553 2683    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         
Sub-Investigator: Philippe Morel, MD         
Sponsors and Collaborators
Nicolas C. Buchs
Investigators
Principal Investigator: Nicolas C Buchs, MD University Hospital, Geneva
  More Information

No publications provided

Responsible Party: Nicolas C. Buchs, Faculty surgeon, University Hospital, Geneva
ClinicalTrials.gov Identifier: NCT01346436     History of Changes
Other Study ID Numbers: CER-11-047
Study First Received: April 29, 2011
Last Updated: December 1, 2014
Health Authority: Switzerland: Ethikkommission

Additional relevant MeSH terms:
Pelvic Organ Prolapse
Prolapse
Rectal Prolapse
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Pathological Conditions, Anatomical
Rectal Diseases

ClinicalTrials.gov processed this record on July 01, 2015