Laparoscopic Sacropexy With Robot-Assisted Surgical System

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Vaginal Vault Prolapse

Intervention / Treatment
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* Procedure: laparoscopic robot-assisted sacropexy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: vaginal vault prolapse recurrence after vaginal prolapse repair signed consent Exclusion Criteria: rectocele BMI > 40

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Procedure: laparoscopic robot-assisted sacropexy<br>* Repair of vaginal vault prolapse with laparoscopic sacropexy assisted by robotic surgical system (da Vinci®-System)<br>* Other names: robotic laparoscopic sacrocolpopexy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of surgery |  | during hospitalisation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complications |  | 6 months after hospitalisation | 
| Anatomical results |  | 6 months after hospitalisation | 
| Quality of life |  | 6 months after hospitalisation | 
| Costs |  | 6 months after hospitalisation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vaginal vault prolapse repair, robot-assisted laparoscopic sacropexy, robot-assisted laparoscopic sacrocolpopexy, robotic laparoscopic sacropexy