Comparison of 2-Dimensional and 3-Dimensional Laparoscopic Visions

Diagnostic Self Evaluation Clinical Trial

Official title:

Comparison of 2-Dimensional and New Generation 3-Dimensional Laparoscopic Visions In An Experimental Model

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01799577
• Other study ID #: BEHGynobs-4
• Status: Completed
• Phase: N/A
• First received: February 13, 2013
• Last updated: December 31, 2013
• Start date: January 2013
• Est. completion date: December 2013

Study information

• Verified date: December 2013
• Source: Bagcilar Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years to 60 Years

Eligibility

Inclusion Criteria:

medical doctors

Exclusion Criteria:

disabled person (about arms or vision problems)

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Diagnostic Self Evaluation

Intervention

Procedure:
• Laparoscopic surgery
Two methods will be compare

Locations

Country	Name	City	State
Turkey	Bagcilar Trainig and Research Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Bagcilar Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	In order to test whether the 3-D laparoscopy vision system is superior or not than the 2-D laparoscopic vision system.	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	No