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

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

Study Overview

• Status: Completed
• Conditions: Surgical Performance
• Intervention / Treatment: Other: 3D-display system; Other: 4K-display system

• Study Type: Interventional
• Enrollment (Actual): 133
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Cologne, Germany, 50931
    • University of Cologne, Department of General, Visceral and Cancer Surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Universitätsklinikum Köln
• Investigators: Principal Investigator: Roger Wahba, MD, PHD, Universitätsklinikum Köln

Publications and helpful links

General Publications

• Gietzelt C, Datta R, Busshoff J, Bruns T, Wahba R, Hedergott A. The influence of stereoscopic vision on surgical performance in minimal invasive surgery-a substudy of the IDOSP-Study (Influence of 3D- vs. 4 K-Display Systems on Surgical Performance in minimal invasive surgery). Langenbecks Arch Surg. 2022 Nov;407(7):3069-3078. doi: 10.1007/s00423-022-02608-3. Epub 2022 Jul 22.
• Wahba R, Datta RR, Hedergott A, Busshoff J, Bruns T, Kleinert R, Dieplinger G, Fuchs H, Gietzelt C, Moller D, Hellmich M, Bruns CJ, Stippel DL. 3D vs. 4K Display System - Influence of "State-of-the-art"-Display Technique On Surgical Performance (IDOSP-Study) in minimally invasive surgery: protocol for a randomized cross-over trial. Trials. 2019 May 28;20(1):299. doi: 10.1186/s13063-019-3330-7. Erratum In: Trials. 2020 Mar 12;21(1):257.

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 28, 2018
• Primary Completion (ACTUAL): October 4, 2019
• Study Completion (ACTUAL): February 24, 2020

Study Registration Dates

• First Submitted: February 7, 2018
• First Submitted That Met QC Criteria: February 19, 2018
• First Posted (ACTUAL): February 26, 2018

Study Record Updates

• Last Update Posted (ACTUAL): March 3, 2020
• Last Update Submitted That Met QC Criteria: February 29, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 17-388

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No