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Laparoscopic Sacropexy With Robot-Assisted Surgical System (RobPex)

Primary Purpose

Vaginal Vault Prolapse

Status
Unknown status
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
laparoscopic robot-assisted sacropexy
Sponsored by
Kantonsspital Aarau
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vaginal Vault Prolapse focused on measuring vaginal vault prolapse repair, robot-assisted laparoscopic sacropexy, robot-assisted laparoscopic sacrocolpopexy, robotic laparoscopic sacropexy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • rectocele
  • BMI > 40

Sites / Locations

  • Kantonsspital AarauRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Outcomes

Primary Outcome Measures

Duration of surgery

Secondary Outcome Measures

Complications
Anatomical results
Quality of life
Costs

Full Information

First Posted
April 21, 2009
Last Updated
June 23, 2009
Sponsor
Kantonsspital Aarau
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1. Study Identification

Unique Protocol Identification Number
NCT00886223
Brief Title
Laparoscopic Sacropexy With Robot-Assisted Surgical System
Acronym
RobPex
Official Title
Laparoscopic Sacropexy: Clinical Prospective Study With Robot-Assisted Technique(da Vinci®-System)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2009
Overall Recruitment Status
Unknown status
Study Start Date
April 2009 (undefined)
Primary Completion Date
April 2011 (Anticipated)
Study Completion Date
April 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Kantonsspital Aarau

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vaginal Vault Prolapse
Keywords
vaginal vault prolapse repair, robot-assisted laparoscopic sacropexy, robot-assisted laparoscopic sacrocolpopexy, robotic laparoscopic sacropexy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
laparoscopic robot-assisted sacropexy
Other Intervention Name(s)
robotic laparoscopic sacropexy, robot-assisted laparoscopic sacrocolpopexy, robotic laparoscopic sacrocolpopexy
Intervention Description
Repair of vaginal vault prolapse with laparoscopic sacropexy assisted by robotic surgical system (da Vinci®-System)
Primary Outcome Measure Information:
Title
Duration of surgery
Time Frame
during hospitalisation
Secondary Outcome Measure Information:
Title
Complications
Time Frame
6 months after hospitalisation
Title
Anatomical results
Time Frame
6 months after hospitalisation
Title
Quality of life
Time Frame
6 months after hospitalisation
Title
Costs
Time Frame
6 months after hospitalisation

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: vaginal vault prolapse recurrence after vaginal prolapse repair signed consent Exclusion Criteria: rectocele BMI > 40
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dimitri Sarlos, MD
Phone
+41 62 8385065
Email
Dimitri.Sarlos@ksa.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dimitri Sarlos, MD
Organizational Affiliation
Kantonsspital Aarau, Department of Obsterics and Gynecology
Official's Role
Study Chair
Facility Information:
Facility Name
Kantonsspital Aarau
City
Aarau
ZIP/Postal Code
5001
Country
Switzerland
Individual Site Status
Recruiting

12. IPD Sharing Statement

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Laparoscopic Sacropexy With Robot-Assisted Surgical System

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