Laparoscopic Sacropexy With Robot-Assisted Surgical System

Not Applicable

• Conditions: Vaginal Vault Prolapse
• Interventions: Procedure: laparoscopic robot-assisted sacropexy

• Registration Number: NCT00886223
• Lead Sponsor: Kantonsspital Aarau

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.

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 Timeline

• Study Start: 2009-04
• Study First Submitted: 2009-04-21
• Study First Submitted QC: 2009-04-21
• Study First Posted: 2009-04-22
• Status Verified: 2009-06
• Last Update Submitted: 2009-06-23
• Last Update Posted: 2009-06-24
• Primary Completion: 2011-04
• Study Completion: 2011-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 30

Inclusion Criteria

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

Exclusion Criteria

• rectocele
• BMI > 40

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	laparoscopic robot-assisted sacropexy	-

Primary Outcome Measures

Name	Time	Method
Duration of surgery	during hospitalisation

Secondary Outcome Measures

Name	Time	Method
Quality of life	6 months after hospitalisation
Costs	6 months after hospitalisation
Complications	6 months after hospitalisation
Anatomical results	6 months after hospitalisation

Trial Locations

Locations (1)

Kantonsspital Aarau; 🇨🇭 Aarau, Switzerland