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

Sponsor
Universitätsklinikum Köln (Other)
Overall Status
Completed
CT.gov ID
NCT03445429
Collaborator
(none)
133
1
2
23.9
5.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: 3D-display system
  • Other: 4K-display system
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
133 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
3D- vs. 4K-display System - Influence of "State-of-the-art"-Display Technique on Surgical Performance
Actual Study Start Date :
Feb 28, 2018
Actual Primary Completion Date :
Oct 4, 2019
Actual Study Completion Date :
Feb 24, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: 3D-display system

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
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.

Experimental: 4K-display system

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
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.

Outcome Measures

Primary Outcome Measures

  1. 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

  2. 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

  1. 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

  2. Learning curve [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 [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 [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 [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 [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 [immediately after tasks with both systems (3D and 4K) are performed, Day 1]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Cologne, Department of General, Visceral and Cancer Surgery Cologne Germany 50931

Sponsors and Collaborators

  • Universitätsklinikum Köln

Investigators

  • Principal Investigator: Roger Wahba, MD, PhD, Universitätsklinikum Köln

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Roger Wahba, MD, PhD, Priv.-Doz. Dr. med. Roger Wahba, Universitätsklinikum Köln
ClinicalTrials.gov Identifier:
NCT03445429
Other Study ID Numbers:
  • 17-388
First Posted:
Feb 26, 2018
Last Update Posted:
Mar 3, 2020
Last Verified:
Feb 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Mar 3, 2020