RobPex: Laparoscopic Sacropexy With Robot-Assisted Surgical System
Study Details
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.
Condition or Disease | Intervention/Treatment | Phase |
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N/A |
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 Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: 1
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Procedure: laparoscopic robot-assisted sacropexy
Repair of vaginal vault prolapse with laparoscopic sacropexy assisted by robotic surgical system (da Vinci®-System)
Other Names:
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Outcome Measures
Primary Outcome Measures
- Duration of surgery [during hospitalisation]
Secondary Outcome Measures
- Complications [6 months after hospitalisation]
- Anatomical results [6 months after hospitalisation]
- Quality of life [6 months after hospitalisation]
- Costs [6 months after hospitalisation]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
vaginal vault prolapse
-
recurrence after vaginal prolapse repair
-
signed consent
Exclusion Criteria:
-
rectocele
-
BMI > 40
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Kantonsspital Aarau | Aarau | Switzerland | 5001 |
Sponsors and Collaborators
- Kantonsspital Aarau
Investigators
- Study Chair: Dimitri Sarlos, MD, Kantonsspital Aarau, Department of Obsterics and Gynecology
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- KSA-RobPex1