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Laparoscopic Sacropexy With Robot-Assisted Surgical System — RobPex  

Vaginal Vault Prolapse Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00886223
Study type Interventional
Source Kantonsspital Aarau
Contact Dimitri Sarlos, MD
Phone +41 62 8385065
Email Dimitri.Sarlos@ksa.ch
Status Recruiting
Phase N/A
Start date April 2009
Completion date April 2011
View Details
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