Laparoscopic Sacropexy With Robot-Assisted Surgical System
NCT ID: NCT00886223
Last Updated: 2009-06-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
30 participants
INTERVENTIONAL
2009-04-30
2011-04-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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1
laparoscopic robot-assisted sacropexy
Repair of vaginal vault prolapse with laparoscopic sacropexy assisted by robotic surgical system (da Vinci®-System)
Interventions
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laparoscopic robot-assisted sacropexy
Repair of vaginal vault prolapse with laparoscopic sacropexy assisted by robotic surgical system (da Vinci®-System)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* recurrence after vaginal prolapse repair
* signed consent
Exclusion Criteria
* BMI \> 40
18 Years
FEMALE
Yes
Sponsors
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Kantonsspital Aarau
OTHER
Responsible Party
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Kantonsspital Aarau
Principal Investigators
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Dimitri Sarlos, MD
Role: STUDY_CHAIR
Kantonsspital Aarau, Department of Obsterics and Gynecology
Locations
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Kantonsspital Aarau
Aarau, , Switzerland
Countries
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Central Contacts
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Other Identifiers
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KSA-RobPex1
Identifier Type: -
Identifier Source: org_study_id
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