Influence of 3D- vs. 4K-display System on Surgical Performance

Not Applicable

Completed

• Conditions: Surgical Performance

• Registration Number: NCT03445429
• Lead Sponsor: Universitätsklinikum Köln

Brief Summary

Modern display technique seems to optimize visualization in minimal-invasive surgery. Many systems are available right now with a fundamental difference between the passive polarizing 3-dimensional (3D) and 2-dimensional (2D) technique. Data seems to show a benefit for the 3D technique in the visualization of the operative field. This could lead to more precision in minimal-invasive surgery. 2D-systems with high resolution of 4.096 x 2.180 pixels (4K) could be a promising alternative. This study wants to evaluate if 3D- or 4K- display technique could optimize surgeons´ view and improve the performance during minimal-invasive surgery. Therefore medical students and surgeons of different experience levels will perform surgical tasks on a minimal-invasive training system.They will be randomized to use first the 3D- or the 4K-display system in the training set-up. After completing the tasks with one system the minimal-invasive training set-up will be repeated with the other display system. NASA (National Aeronautics and Space Administration) task load index is evaluated after each round. The ability for stereoscopic vision is tested after finishing the complete training set-up with both systems. The primary outcome parameter surgical performance will be evaluated in this study defined as the performance time and the number of defined mistakes made during each task.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-02-07
• Study First Submitted QC: 2018-02-19
• Study First Posted: 2018-02-26
• Study Start: 2018-02-28
• Primary Completion: 2019-10-04
• Status Verified: 2020-02
• Study Completion: 2020-02-24
• Last Update Submitted: 2020-02-29
• Last Update Posted: 2020-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 133

Inclusion Criteria

• medical student
• medical doctor
• informed consent signed

Exclusion Criteria

• known deficit of stereoscopic view
• experience with the tasks of the minimal-invasive training set-up
• not able to use both hands for minimal-invasive training set-up

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Surgical Performance Time	immediately after tasks are performed, Day 1	The surgical performance time is defined as time needed to complete the tasks at the minimal-invasive trainer. the time is measured in seconds
Surgical Performance Errors	immediately after tasks are performed, Day 1	it is measured once directly after completing the task with the 3D performance time and the number of errors: the surgical performance errors are defined as the number of defined errors made during the performance of the tasks at the minimal invasive trainer surgical performance errors = number of errors

Secondary Outcome Measures

Name	Time	Method
Task Load	immediately after tasks are performed, Day 1	task load felt by the subjects evaluated by NASA task load index, after tasks with 3 D- and 4 K- systems are completed NASA task load index is evaluated once
Learning curve	immediately after tasks with both systems (3D and 4K) are performed, Day 1	Learning curve after the completeness of the tasks
Stereoscopic view Bagolini	immediately after tasks with both systems (3D and 4K) are performed, Day 1	Qualitative test for assesment of stereoscopic view units : positive /negative/diplopia
Stereoscopic view Lang I/II	immediately after tasks with both systems (3D and 4K) are performed, Day 1	Semi-quantitative test for assesment of stereoscopic view units : arc seconds
Stereoscopic view Titmus	immediately after tasks with both systems (3D and 4K) are performed, Day 1	Semi-quantitative test for assesment of stereoscopic view units : arc seconds (fly at 3550 arc seconds, animals at 400, 200, 100 arc seconds,rings at 800, 400, 200, 140, 100, 80, 60, 50, 40 arc seconds)
Stereoscopic view TNO	immediately after tasks with both systems (3D and 4K) are performed, Day 1	Semi-quantitative test for assesment of stereoscopic view units: arc seconds (480, 240, 120, 60, 30, 15)
Stereoscopic view Cover	immediately after tasks with both systems (3D and 4K) are performed, Day 1	qualitative test for assesment of stereoscopic view units: phoria/tropia

Trial Locations

Locations (1)

University of Cologne, Department of General, Visceral and Cancer Surgery; 🇩🇪 Cologne, Germany