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Completed

NCT Number: NCT03445429

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Cologne, Department of General, Visceral and Cancer Surgery

Cologne, 50931, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

3D-display system

Other

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

Other

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.

Primary outcomes

  1. Surgical Performance Time

    Time frame: 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

  2. Surgical Performance Errors

    Time frame: 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 outcomes

  1. Task Load

    Time frame: 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

  2. Learning curve

    Time frame: immediately after tasks with both systems (3D and 4K) are performed, Day 1

    Learning curve after the completeness of the tasks

  3. Stereoscopic view Bagolini

    Time frame: immediately after tasks with both systems (3D and 4K) are performed, Day 1

    Qualitative test for assesment of stereoscopic view units : positive /negative/diplopia

  4. Stereoscopic view Lang I/II

    Time frame: immediately after tasks with both systems (3D and 4K) are performed, Day 1

    Semi-quantitative test for assesment of stereoscopic view units : arc seconds

  5. Stereoscopic view Titmus

    Time frame: 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)

  6. Stereoscopic view TNO

    Time frame: 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)

  7. Stereoscopic view Cover

    Time frame: immediately after tasks with both systems (3D and 4K) are performed, Day 1

    qualitative test for assesment of stereoscopic view units: phoria/tropia

Sponsors and collaborators

Lead sponsor

Universitätsklinikum Köln

Other

Registry information

Official study title

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

Acronym: IDOSP

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Feb 26, 2018
Registry last updated
Mar 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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