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

Study Overview
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Brief Summary
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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.

Official Title
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3D- vs. 4K-display System - Influence of State-of-the-art-Display Technique on Surgical Performance

Conditions
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Surgical Performance

Intervention / Treatment
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* Other: 3D-display system
* Other: 4K-display system


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 3D-display system<br>Subjects in this arm will perform the tasks on the minimal-invasive training set-up first with the 3D-display system. Then they will do the NASA task load index questionnaire. After that they will perform the tasks with the 4 K-display system. After that again a NASA Task load index questionnaire is performed. | Other: 3D-display system<br>* The subjects will perform tasks on a minimal-invasive/laparoscopic training set-up. They will perform the tasks with a 3D-display system or a 4K-display system. The intervention type 3D-display system means that the training-set up is performed first with 3D-display system an after that with the 4K-display system.<br>|
| Experimental: 4K-display system<br>Subjects in this arm will perform the tasks on the minimal-invasive training set-up first with the 4K-display system. Then they will do the NASA task load index questionnaire. After that they will perform the tasks with the 3D-display system. After that again a NASA Task load index questionnaire is performed. | Other: 4K-display system<br>* The subjects will perform tasks on a minimal-invasive/laparoscopic training set-up. They will perform the tasks with a 3D-display system or a 4K-display system. The intervention type 4K-display system means that the training-set up is performed first with 4K-display system and after that with the 3D-display system.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical Performance Time | The surgical performance time is defined as time needed to complete the tasks at the minimal-invasive trainer. the time is measured in seconds | immediately after tasks are performed, Day 1 | 
| Surgical Performance Errors | 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 | immediately after tasks are performed, Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Task Load | 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 | immediately after tasks are performed, Day 1 | 
| Learning curve | Learning curve after the completeness of the tasks | immediately after tasks with both systems (3D and 4K) are performed, Day 1 | 
| Stereoscopic view Bagolini | Qualitative test for assesment of stereoscopic view units : positive /negative/diplopia | immediately after tasks with both systems (3D and 4K) are performed, Day 1 | 
| Stereoscopic view Lang I/II | Semi-quantitative test for assesment of stereoscopic view units : arc seconds | immediately after tasks with both systems (3D and 4K) are performed, Day 1 | 
| Stereoscopic view Titmus | 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) | immediately after tasks with both systems (3D and 4K) are performed, Day 1 | 
| Stereoscopic view TNO | Semi-quantitative test for assesment of stereoscopic view units: arc seconds (480, 240, 120, 60, 30, 15) | immediately after tasks with both systems (3D and 4K) are performed, Day 1 | 
| Stereoscopic view Cover | qualitative test for assesment of stereoscopic view units: phoria/tropia | immediately after tasks with both systems (3D and 4K) are performed, Day 1 |