- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01799577
Comparison of 2-Dimensional and 3-Dimensional Laparoscopic Visions
December 31, 2013 updated by: Bagcilar Training and Research Hospital
Comparison of 2-Dimensional and New Generation 3-Dimensional Laparoscopic Visions In An Experimental Model
This study tests the hypothesis that use of the 3-D laparoscopic vision system (Viking Systems, La Jolla, CA) can significantly improve technical ability on a complex laparoscopic tasks in an experimental model.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
7 tasks on a 3-D laparoscopic instrument fitted to the trainer box and subjective criteria (4 point lickert scale) were evaluated for this study.
Totally twenty-four participants (8 experienced, 8 minimal experienced and 8 novices) were evaluated for different 10 tasks (touch the marked circle, pass the two circle with needle, pick-beads and place, grape the suture, move the needle from one instrument to another instrument, pick-and-place, cutting, three different suturing) in term of total task time and error number.
Statistical Package Program was used to perform statistical analyses.
The data were presented as arithmetic means and standard deviations were calculated in each group.
A P value of <0.05 was considered to be statistically significant.
Study Type
Observational
Enrollment (Actual)
24
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Istanbul, Turkey, 12345
- Bagcilar Trainig and Research Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
25 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Medical doctors
Description
Inclusion Criteria:
medical doctors
Exclusion Criteria:
disabled person (about arms or vision problems)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Gynecologist
Gynecologist can use laparoscopic surgery.
|
Two methods will be compare
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
In order to test whether the 3-D laparoscopy vision system is superior or not than the 2-D laparoscopic vision system.
Time Frame: 15 days
|
We want to test the 3-D laparoscopic vision system (Viking Systems, La Jolla, CA) can significantly improve technical ability on a complex laparoscopic tasks in an experimental model.
7 tasks on a 3-D laparoscopic instrument fitted to the trainer box and subjective criteria (4 point lickert scale) were evaluated for this study.
Totally twenty-four participants (8 experienced, 8 minimal experienced and 8 novices) were evaluated for different 10 tasks in term of total task time and error number.
|
15 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: TANER USTA, M.D., Bagcilar Training and Research Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2013
Primary Completion (Actual)
December 1, 2013
Study Completion (Actual)
December 1, 2013
Study Registration Dates
First Submitted
February 13, 2013
First Submitted That Met QC Criteria
February 25, 2013
First Posted (Estimate)
February 27, 2013
Study Record Updates
Last Update Posted (Estimate)
January 3, 2014
Last Update Submitted That Met QC Criteria
December 31, 2013
Last Verified
December 1, 2013
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- BEHGynobs-4
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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