Laparoscopic Sacropexy With Robot-Assisted Surgical System (RobPex)
|ClinicalTrials.gov Identifier: NCT00886223|
Recruitment Status : Unknown
Verified June 2009 by Kantonsspital Aarau.
Recruitment status was: Recruiting
First Posted : April 22, 2009
Last Update Posted : June 24, 2009
|Condition or disease||Intervention/treatment||Phase|
|Vaginal Vault Prolapse||Procedure: laparoscopic robot-assisted sacropexy||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Laparoscopic Sacropexy: Clinical Prospective Study With Robot-Assisted Technique(da Vinci®-System)|
|Study Start Date :||April 2009|
|Estimated Primary Completion Date :||April 2011|
|Estimated Study Completion Date :||April 2011|
Procedure: laparoscopic robot-assisted sacropexy
Repair of vaginal vault prolapse with laparoscopic sacropexy assisted by robotic surgical system (da Vinci®-System)
- Duration of surgery [ Time Frame: during hospitalisation ]
- Complications [ Time Frame: 6 months after hospitalisation ]
- Anatomical results [ Time Frame: 6 months after hospitalisation ]
- Quality of life [ Time Frame: 6 months after hospitalisation ]
- Costs [ Time Frame: 6 months after hospitalisation ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00886223
|Contact: Dimitri Sarlos, MD||+41 62 8385065||Dimitri.Sarlos@ksa.ch|
|Aarau, Switzerland, 5001|
|Study Chair:||Dimitri Sarlos, MD||Kantonsspital Aarau, Department of Obsterics and Gynecology|