Back to resultsClinical Trial Comparing Conventional and Robot-assisted(Da Vinci®)Laparoscopic Interventions for Hysterectomy
Primary Purpose
Laparoscopic Technique no Switch to Open, Duration of Surgery, Intraoperative Complications
Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Conventional Laparoscopic Hysterectomy
Robot-assisted (Da Vinci®) laparoscopic hysterectomy
Sponsored by
About this trial
This is an interventional treatment trial for Laparoscopic Technique no Switch to Open focused on measuring Laparoscopic Hysterectomy, Robot-assisted Laparoscopic Hysterectomy, Robot-assisted Surgery
Eligibility Criteria
Inclusion Criteria:
- Indication for laparoscopic hysterectomy
- Patients BMI < 40
- Signed consent
Exclusion Criteria:
- Estimated uterus weight >400 g
- No combination with other procedures
- No underlying malignant condition
Sites / Locations
- Kantonsspital Aarau
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
1
2
Arm Description
Randomized group of patients receiving conventional laparoscopic hysterectomy
Randomized group of patients receiving robot-assisted laparoscopic hysterectomy
Outcomes
Primary Outcome Measures
Duration of Surgery
•Mean Time to complete surgery from cut to suture
Secondary Outcome Measures
Complications
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00683293
Brief Title
Clinical Trial Comparing Conventional and Robot-assisted(Da Vinci®)Laparoscopic Interventions for Hysterectomy
Official Title
Laparoscopic Hysterectomy: a Clinical Randomized Trial Comparing Conventional and Robot-assisted(Da Vinci®)Techniques
Study Type
Interventional
2. Study Status
Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
December 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kantonsspital Aarau
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of this study is to compare conventional with robot-assisted (Da Vinci®) laparoscopic hysterectomy regarding operating time peri-operative outcome and costs.
Detailed Description
During the last few years robot-assisted surgery has been introduced in many surgical specialties and experiences in gynaecological 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Laparoscopic Technique no Switch to Open, Duration of Surgery, Intraoperative Complications, Postoperative Complications
Keywords
Laparoscopic Hysterectomy, Robot-assisted Laparoscopic Hysterectomy, Robot-assisted Surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
Randomized group of patients receiving conventional laparoscopic hysterectomy
Arm Title
2
Arm Type
Active Comparator
Arm Description
Randomized group of patients receiving robot-assisted laparoscopic hysterectomy
Intervention Type
Procedure
Intervention Name(s)
Conventional Laparoscopic Hysterectomy
Other Intervention Name(s)
- Minimal invasive hysterectomy,, - Laparoscopic removal of uterus,, - Minimal invasive removal of uterus
Intervention Description
Removal of uterus via standard laparoscopic techniques
Intervention Type
Procedure
Intervention Name(s)
Robot-assisted (Da Vinci®) laparoscopic hysterectomy
Other Intervention Name(s)
- Robot-assisted(Da Vinci®)laparoscopic hysterectomy, - Robot-assisted minimal invasive hysterectomy
Intervention Description
Removal of uterus by robot-assisted laparoscopic technique
Primary Outcome Measure Information:
Title
Duration of Surgery
Description
•Mean Time to complete surgery from cut to suture
Time Frame
after surgey
Secondary Outcome Measure Information:
Title
Complications
Time Frame
up to 2 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Indication for laparoscopic hysterectomy
Patients BMI < 40
Signed consent
Exclusion Criteria:
Estimated uterus weight >400 g
No combination with other procedures
No underlying malignant condition
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dimitri Sarlos, MD
Organizational Affiliation
Kantonsspital Aarau
Official's Role
Study Chair
Facility Information:
Facility Name
Kantonsspital Aarau
City
Aarau
Country
Switzerland
12. IPD Sharing Statement
Citations:
PubMed Identifier
22914470
Citation
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.
Results Reference
result
Learn more about this trial
Clinical Trial Comparing Conventional and Robot-assisted(Da Vinci®)Laparoscopic Interventions for Hysterectomy
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