Laparoscopic Sacropexy With Robot-Assisted Surgical System (RobPex)

June 23, 2009 updated by: Kantonsspital Aarau

Laparoscopic Sacropexy: Clinical Prospective Study With Robot-Assisted Technique(da Vinci®-System)

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Switzerland
      • Aarau, Switzerland, 5001
        • Recruiting
        • Kantonsspital Aarau

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • vaginal vault prolapse
  • recurrence after vaginal prolapse repair
  • signed consent

Exclusion Criteria:

  • rectocele
  • BMI > 40

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Duration of surgery
Time Frame: during hospitalisation
during hospitalisation

Secondary Outcome Measures

Outcome Measure
Time Frame
Complications
Time Frame: 6 months after hospitalisation
6 months after hospitalisation
Anatomical results
Time Frame: 6 months after hospitalisation
6 months after hospitalisation
Quality of life
Time Frame: 6 months after hospitalisation
6 months after hospitalisation
Costs
Time Frame: 6 months after hospitalisation
6 months after hospitalisation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kantonsspital Aarau

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (ANTICIPATED)

April 1, 2011

Study Completion (ANTICIPATED)

April 1, 2011

Study Registration Dates

First Submitted

April 21, 2009

First Submitted That Met QC Criteria

April 21, 2009

First Posted (ESTIMATE)

April 22, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

June 24, 2009

Last Update Submitted That Met QC Criteria

June 23, 2009

Last Verified

June 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KSA-RobPex1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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