Clinical trial NCT03445429: Influence of 3D- vs. 4K-display System on Surgical Performance
Official title: 3D- vs. 4K-display System - Influence of "State-of-the-art"-Display Technique on Surgical Performance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgical Performance
Lead sponsor: Universitätsklinikum Köln
Sponsor class: OTHER
First posted: 2018-02-26
Enrollment: 133
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Surgical Performance Time
timeFrame: immediately after tasks are performed, Day 1
measure: Surgical Performance Errors
timeFrame: immediately after tasks are performed, Day 1
Secondary outcomes:
measure: Task Load
timeFrame: immediately after tasks are performed, Day 1
measure: Learning curve
timeFrame: immediately after tasks with both systems (3D and 4K) are performed, Day 1
measure: Stereoscopic view Bagolini
timeFrame: immediately after tasks with both systems (3D and 4K) are performed, Day 1
measure: Stereoscopic view Lang I/II
timeFrame: immediately after tasks with both systems (3D and 4K) are performed, Day 1
measure: Stereoscopic view Titmus
timeFrame: immediately after tasks with both systems (3D and 4K) are performed, Day 1
measure: Stereoscopic view TNO
timeFrame: immediately after tasks with both systems (3D and 4K) are performed, Day 1
measure: Stereoscopic view Cover
timeFrame: immediately after tasks with both systems (3D and 4K) are performed, Day 1
Other outcomes:
Locations:
city: Cologne
country: Germany
facility: University of Cologne, Department of General, Visceral and Cancer Surgery
Study officials:
affiliation: Universitätsklinikum Köln
name: Roger Wahba, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.