RobPex: Laparoscopic Sacropexy With Robot-Assisted Surgical System

Sponsor
Kantonsspital Aarau (Other)
Overall Status
Unknown status
CT.gov ID
NCT00886223
Collaborator
(none)
30
1
1
24
1.3

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
N/A

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:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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

    Criteria

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

    • recurrence after vaginal prolapse repair

    • signed consent

    Exclusion Criteria:
    • rectocele

    • BMI > 40

    Contacts and Locations

    Locations

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

    Sponsors and Collaborators

    • Kantonsspital Aarau

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00886223
    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