RobPex: Laparoscopic Sacropexy With Robot-Assisted Surgical System

Kantonsspital Aarau (Other)
Overall Status
Unknown status ID

Study Details

Study Description

Brief Summary

The aim of the study is to evaluate safety and outcome of robot-assisted laparoscopic sacropexy regarding perioperative data, objective anatomical results and postoperative quality of life.

Condition or Disease Intervention/Treatment Phase
  • Procedure: laparoscopic robot-assisted sacropexy

Detailed Description

Vaginal vault prolapse is a common finding in Gynecology. Many different approaches for vaginal vault prolapse repair are available. During the last few years robot-assisted surgery has been introduced in many surgical specialties and experiences in gynecologic surgery are very limited.

Several aspects like the wider range of motion of robot-instruments leading to more precision in surgery, the 3 dimensional optical system and the ergonomically designed console may offer some advantages. For better judgment these possible benefits as well as safety and outcome need to be evaluated and compared with conventional laparoscopic sacropexy techniques.

This prospective clinical study evaluates robot-assisted laparoscopic sacropexy (da Vinci®-System) focusing on peri-operative data, objective anatomical results and postoperative quality of life and compares the results with conventional laparoscopic sacropexy. Pre- peri- and post-operative data are collected using the prolapse quantification system (POP-Q) and the German Pelvic Floor questionnaire. The objective of the study will be to investigate if the robot assisted procedure shows significant advantages for the patient considering duration of surgery, complications, hospitalization, quality of life and costs.

Study Design

Study Type:
Anticipated Enrollment :
30 participants
Intervention Model:
Single Group Assignment
None (Open Label)
Primary Purpose:
Official Title:
Laparoscopic Sacropexy: Clinical Prospective Study With Robot-Assisted Technique(da Vinci®-System)
Study Start Date :
Apr 1, 2009
Anticipated Primary Completion Date :
Apr 1, 2011
Anticipated Study Completion Date :
Apr 1, 2011

Arms and Interventions

Arm Intervention/Treatment
Experimental: 1

Procedure: laparoscopic robot-assisted sacropexy
Repair of vaginal vault prolapse with laparoscopic sacropexy assisted by robotic surgical system (da Vinci®-System)
Other Names:
  • robotic laparoscopic sacropexy
  • robot-assisted laparoscopic sacrocolpopexy
  • robotic laparoscopic sacrocolpopexy
  • Outcome Measures

    Primary Outcome Measures

    1. Duration of surgery [during hospitalisation]

    Secondary Outcome Measures

    1. Complications [6 months after hospitalisation]

    2. Anatomical results [6 months after hospitalisation]

    3. Quality of life [6 months after hospitalisation]

    4. Costs [6 months after hospitalisation]

    Eligibility Criteria


    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Accepts Healthy Volunteers:
    Inclusion Criteria:
    • vaginal vault prolapse

    • recurrence after vaginal prolapse repair

    • signed consent

    Exclusion Criteria:
    • rectocele

    • BMI > 40

    Contacts and Locations


    Site City State Country Postal Code
    1 Kantonsspital Aarau Aarau Switzerland 5001

    Sponsors and Collaborators

    • Kantonsspital Aarau


    • Study Chair: Dimitri Sarlos, MD, Kantonsspital Aarau, Department of Obsterics and Gynecology

    Study Documents (Full-Text)

    None provided.

    More Information


    None provided.
    Responsible Party:
    , , Identifier:
    Other Study ID Numbers:
    • KSA-RobPex1
    First Posted:
    Apr 22, 2009
    Last Update Posted:
    Jun 24, 2009
    Last Verified:
    Jun 1, 2009

    Study Results

    No Results Posted as of Jun 24, 2009