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Comparison of 2-Dimensional and 3-Dimensional Laparoscopic Visions

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ClinicalTrials.gov Identifier: NCT01799577
Recruitment Status : Completed
First Posted : February 27, 2013
Last Update Posted : January 3, 2014
Sponsor:
Information provided by (Responsible Party):
Bagcilar Training and Research Hospital

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment
Diagnostic Self Evaluation Procedure: Laparoscopic surgery

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 Design
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Study Type : Observational
Actual Enrollment : 24 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Comparison of 2-Dimensional and New Generation 3-Dimensional Laparoscopic Visions In An Experimental Model
Study Start Date : January 2013
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013
Groups and Cohorts
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Group/Cohort Intervention/treatment
Gynecologist
Gynecologist can use laparoscopic surgery.
 Procedure: Laparoscopic surgery
Two methods will be compare


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   25 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Medical doctors
Criteria

Inclusion Criteria:

medical doctors

Exclusion Criteria:

disabled person (about arms or vision problems)

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01799577


Locations
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Turkey
Bagcilar Trainig and Research Hospital
Istanbul, Turkey, 12345
Sponsors and Collaborators
Bagcilar Training and Research Hospital
Investigators
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Principal Investigator: TANER USTA, M.D. Bagcilar Training and Research Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Bagcilar Training and Research Hospital
ClinicalTrials.gov Identifier: NCT01799577    
Other Study ID Numbers: BEHGynobs-4
First Posted: February 27, 2013    Key Record Dates
Last Update Posted: January 3, 2014
Last Verified: December 2013
Keywords provided by Bagcilar Training and Research Hospital:
laparoscopy, accuracy, duration