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

Surgical Performance Clinical Trial

— IDOSP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03445429
• Other study ID #: 17-388
• Status: Completed
• Phase: N/A
• Start date: February 28, 2018
• Est. completion date: February 24, 2020

Study information

• Verified date: February 2020
• Source: Universitätsklinikum Köln
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 133
• Est. completion date: February 24, 2020
• Est. primary completion date: October 4, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Surgical Performance

Intervention

Other:
• 3D-display system
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.
• 4K-display system
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.

Locations

Country	Name	City	State
Germany	University of Cologne, Department of General, Visceral and Cancer Surgery	Cologne

Sponsors (1)

Lead Sponsor	Collaborator
Universitätsklinikum Köln

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	Learning curve	Learning curve after the completeness of the tasks	immediately after tasks with both systems (3D and 4K) are performed, Day 1
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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