Abstract

We developed an interactive augmented reality tool (HoloPointer) that enables real-time annotation on a laparoscopy monitor for intraoperative guidance. This application operates exclusively via verbal commands and head movements to ensure a sterile workflow. Purpose of this randomized controlled clinical trial was to evaluate the integration of this new technology into the operating room. This prospective single-center study included 32 elective laparoscopic cholecystectomies (29 surgical teams, 15 trainees, 13 trainers). Primary objectives and assessment measures was the HoloPointer's influence on surgical performance (subjective assessment, global operative assessment of laparoscopic skills - GOALS, and Critical View of Safety -CVS). Secondary objectives and outcome variables were its influence on operation time, quality of assistance (5 point likert-scale), and user-friendliness (System Usability Scale - SUS, 0-100 points). Gestural corrections were reduced by 59.4% (4.6 SD 8.1 vs. 1.9 SD 4.7; p > 0.05) and verbal corrections by 36.1% (17.8 SD 12.9 vs. 11.4 SD 8.1; p > 0.05). Subjective surgical performance could be improved by 84,6% of participants. No statistically significant differences were observed for objective parameters GOALS, CVS and operation time. In the SUS, the application achieved an average score of 72.5 SD 16.3 (good user-friendliness). Of the participants, 69.2% wanted to use the HoloPointer more frequently. The majority of trainees had improved their surgical performance using the HoloPointer in elective laparoscopic cholecystectomies, and the rate of classic but potentially misleading corrections was noticeably reduced. The HoloPointer has the potential to improve education in minimally invasive surgery.

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