Laparoscopic Sacropexy With Robot-Assisted Surgical System (RobPex)
Recruitment status was: Recruiting
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Laparoscopic Sacropexy: Clinical Prospective Study With Robot-Assisted Technique(da Vinci®-System)|
- Duration of surgery [ Time Frame: during hospitalisation ] [ Designated as safety issue: Yes ]
- Complications [ Time Frame: 6 months after hospitalisation ] [ Designated as safety issue: No ]
- Anatomical results [ Time Frame: 6 months after hospitalisation ] [ Designated as safety issue: No ]
- Quality of life [ Time Frame: 6 months after hospitalisation ] [ Designated as safety issue: No ]
- Costs [ Time Frame: 6 months after hospitalisation ] [ Designated as safety issue: No ]
|Study Start Date:||April 2009|
|Estimated Study Completion Date:||April 2011|
|Estimated Primary Completion Date:||April 2011 (Final data collection date for primary outcome measure)|
Procedure: laparoscopic robot-assisted sacropexy
Repair of vaginal vault prolapse with laparoscopic sacropexy assisted by robotic surgical system (da Vinci®-System)
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00886223
|Aarau, Switzerland, 5001|
|Study Chair:||Dimitri Sarlos, MD||Kantonsspital Aarau, Department of Obsterics and Gynecology|