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Surgical PerformanceIDOSPNCT03445429

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

A study testing 3D-display system and 4K-display system in people with Surgical Performance, run by Universitätsklinikum Köln at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Surgical Performance
What is being tested?
3D-display system and 4K-display system
Could I receive a placebo?
No, everyone receives an active treatment
How many people
133 participants
Where
1 siteGermany
Study dates
28 Feb 2018to 24 Feb 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • medical student
  • medical doctor
  • informed consent signed

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Germany1 site

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

    Cologne, 50931

Other trials in Germany

About this study

Official title: 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.

Being tested
3D-display system, 4K-display system

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 3D-display systemOther

    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 systemOther

    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.

Study groups in NCT03445429
Study groupRoleWhat they receive
3D-display systemExperimentalSubjects 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.
Receives: Other: 3D-display system
4K-display systemExperimentalSubjects 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.
Receives: Other: 4K-display system

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: immediately after tasks are performed, Day 1

  2. 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

    Measured: immediately after tasks are performed, Day 1

Secondary outcomes (7)

  1. 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

    Measured: immediately after tasks are performed, Day 1

  2. Learning curve

    Learning curve after the completeness of the tasks

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

  3. Stereoscopic view Bagolini

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

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

  4. Stereoscopic view Lang I/II

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

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

  5. 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)

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

  6. Stereoscopic view TNO

    Semi-quantitative test for assesment of stereoscopic view units: arc seconds (480, 240, 120, 60, 30, 15)

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

  7. Stereoscopic view Cover

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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Feb 2018
  2. Study start28 Feb 2018
  3. Primary completion4 Oct 2019
  4. Study completion24 Feb 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Single blind
Who is masked
Participant
Enrolment
133 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03445429
Sponsor's protocol ID
17-388
Acronym
IDOSP
Status last verified
Feb 2020
First submitted
7 Feb 2018
Last updated
3 Mar 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

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.

    PubMed 35869334

  • 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.

    PubMed 31138290

Questions about this trial

What is this clinical trial studying?

A study testing 3D-display system and 4K-display system in people with Surgical Performance, run by Universitätsklinikum Köln at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Surgical Performance Time (time frame: immediately after tasks are performed, Day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03445429, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2020.

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