3D- vs. 4K-Display System - Influence of "State-of-the-art"-Display Technique On Surgical Performance (IDOSP-Study) in minimal invasive surgery: protocol for a randomized cross-over trial
Abstract Abstract Background Three-dimensional (3D) stereoscopic vision is crucial to perform any kind of manual tasks. The reduction from real life 3D- to virtual two-dimensional (2D) sight is a major challenge in minimal invasive surgery (MIS). 3D-display technique has shown to reduce operation time, mistakes, and to improve the learning curve. Therefore it seems to optimize surgical performance for novice and experienced surgeons. Inspired by consumer electronics 4K-display technique was recently introduced to MIS. Due to its high resolution and zoom-effect surgeons should benefit from it. Aim of this study is to evaluate if “state-of-the-art” 3D- versus 4K- display techniques could influence surgical performance. Methods A randomized cross-over single-institution single-blinded trial is designed. It compares the primary outcome parameter “surgical performance”, represented by “performance time “ and “number of mistakes”, using a passive polarizing 3D- and a 4K-display system (2 arms) to perform different tasks in a minimal invasive/laparoscopic training parkour. Secondary outcome parameters are the mental stress load (NASA task load index) and the learning curve. Unexperienced novices (medical students), non-board certified and board-certified abdominal surgeons participate in the trial (i.e. level of experience, 3 strata). The parkour consists of 7 tasks (novices 5 tasks), which will be repeated 3 times. The 1st run of the parkour will be performed with the randomized display system, the 2nd run with the other one. After each run, the mental stress load is measured. After completion of the parkour, all participants are evaluated by an ophthalmologist for visual acuity and stereoscopic vision with five tests. A sample-size of 36 per stratum is required to detect a standardized effect of 1.0 (including additional 5% for a non-parametric approach) with a power of 80% at two-sided type I error of 5%. Thus, altogether 108 subjects need to be enrolled. Discussion Complex surgical procedures are performed in minimal invasive/laparoscopic technique. This study should provide some evidence to decide which display technique a surgeon could choose to optimize his performance. Trial Registration This trial is registered at clinicaltrials.gov (trial number: NCT 03445429, registered February 7, 2018, http://www.clinicaltrials.gov)