Clinical Trial Comparing Conventional and Robot-assisted(Da Vinci®)Laparoscopic Interventions for Hysterectomy
NCT ID: NCT00683293
Last Updated: 2014-04-16
Study Results
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View full resultsBasic Information
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COMPLETED
NA
100 participants
INTERVENTIONAL
2008-11-30
2011-12-31
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 hysterectomy techniques. This randomized clinical trail intends to compare conventional with robot-assisted(da Vinci®-System) laparoscopic hysterectomy regarding specific parameters. The focus of the study will be to investigate if the robot assisted procedure shows significant advantages for the patient considering duration of surgery, complications, hospitalisation and costs.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
Randomized group of patients receiving conventional laparoscopic hysterectomy
Conventional Laparoscopic Hysterectomy
Removal of uterus via standard laparoscopic techniques
2
Randomized group of patients receiving robot-assisted laparoscopic hysterectomy
Robot-assisted (Da Vinci®) laparoscopic hysterectomy
Removal of uterus by robot-assisted laparoscopic technique
Interventions
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Conventional Laparoscopic Hysterectomy
Removal of uterus via standard laparoscopic techniques
Robot-assisted (Da Vinci®) laparoscopic hysterectomy
Removal of uterus by robot-assisted laparoscopic technique
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients BMI \< 40
* Signed consent
Exclusion Criteria
* No combination with other procedures
* No underlying malignant condition
18 Years
FEMALE
Yes
Sponsors
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Kantonsspital Aarau
OTHER
Responsible Party
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Dimitri Sarlos
Head Gynaecology and oncological Gynaecology
Principal Investigators
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Dimitri Sarlos, MD
Role: STUDY_CHAIR
Kantonsspital Aarau
Locations
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Kantonsspital Aarau
Aarau, , Switzerland
Countries
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References
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Sarlos D, Kots L, Stevanovic N, von Felten S, Schar G. Robotic compared with conventional laparoscopic hysterectomy: a randomized controlled trial. Obstet Gynecol. 2012 Sep;120(3):604-11. doi: 10.1097/AOG.0b013e318265b61a.
Other Identifiers
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KSA-RobHyst
Identifier Type: -
Identifier Source: org_study_id
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