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

NCT ID: NCT03445429

Last Updated: 2020-03-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 133 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-28
• Study Completion Date: 2020-02-24

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.

Conditions

Surgical Performance

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

3D-display system

Intervention Type: 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

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.

Group Type: EXPERIMENTAL

4K-display system

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Universitätsklinikum Köln

OTHER

Sponsor Role: lead

Responsible Party

Roger Wahba, MD, PhD

Priv.-Doz. Dr. med. Roger Wahba

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Roger Wahba, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Universitätsklinikum Köln

Locations

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

Cologne, , Germany

Countries

Germany

References

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.

Reference Type: DERIVED

PMID: 35869334 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 31138290 (View on PubMed)

Other Identifiers

17-388

Identifier Type: -

Identifier Source: org_study_id