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

February 29, 2020 updated by: Roger Wahba, MD, PhD, Universitätsklinikum Köln

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
133

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
immediately after tasks are performed, Day 1
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
immediately after tasks are performed, Day 1

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
immediately after tasks are performed, Day 1
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
immediately after tasks with both systems (3D and 4K) are performed, Day 1
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
immediately after tasks with both systems (3D and 4K) are performed, Day 1
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
immediately after tasks with both systems (3D and 4K) are performed, Day 1
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)
immediately after tasks with both systems (3D and 4K) are performed, Day 1
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)
immediately after tasks with both systems (3D and 4K) are performed, Day 1
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
immediately after tasks with both systems (3D and 4K) are performed, Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universitätsklinikum Köln

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Roger Wahba, MD, PHD, Universitätsklinikum Köln

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 28, 2018

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 4, 2019

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 24, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 7, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 19, 2018

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 26, 2018

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 3, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 29, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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