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

Sponsor
Nicolas C. Buchs (Other)
Overall Status
Unknown status
CT.gov ID
NCT01346436
Collaborator
(none)
50
Enrollment
1
Location
2
Arms
109
Duration (Months)
0.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Minimally invasive rectopexy
 Phase 4

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, 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
Study Start Date :
Apr 1, 2011
Anticipated Primary Completion Date :
May 1, 2020
Anticipated Study Completion Date :
May 1, 2020

Arms and Interventions

Arm Intervention/Treatment
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 Names:
  • 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 Names:
  • Surgery for rectal prolapse

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Perioperative outcomes [up to 30 days]

      Including: blood loss, operative time, conversion rate, quality of dissection, pain, complications, hospital stay.

    Secondary Outcome Measures

    1. Functional results [At 12 months]

      Constipation score Incontinence score Quality of life score Sexuality score

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 University Hospital of Geneva, Department of Surgery Geneva Switzerland 1211

    Sponsors and Collaborators

    • Nicolas C. Buchs

    Investigators

    • Principal Investigator: Nicolas C Buchs, MD, University Hospital, Geneva

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Nicolas C. Buchs, Faculty surgeon, University Hospital, Geneva
    ClinicalTrials.gov Identifier:
    NCT01346436
    Other Study ID Numbers:
    • CER-11-047
    First Posted:
    May 3, 2011
    Last Update Posted:
    May 5, 2017
    Last Verified:
    May 1, 2017
    Additional relevant MeSH terms:
    Rectal Prolapse
    Prolapse
    Pelvic Organ Prolapse

    Study Results

    No Results Posted as of May 5, 2017