422 Assessment of an Articulating Laparoscopic Needle Holder (FlexDex™) Compared to a Conventional Rigid Needle Holder in 2-Dimension Vision Amongst Novices: A Randomised Controlled Study

Abstract

Abstract Aim This study aims to compare novice performance of advanced bimanual laparoscopic skills using an articulating laparoscopic device (FlexDex™) compared to a standard rigid needle holder amongst surgical novices in 2-dimension (2D) visualisation. Method In this prospective randomised trial, novices (n=40) without laparoscopic experience were recruited and randomised into two groups, which used either traditional rigid needle holders or the FlexDex™. Both groups performed 10 repetitions of a validated assessment task. Times taken and error rates were recorded, and results were evaluated based on completion times, error rates, and learning curves. Results The intervention group that used the FlexDex™ completed 10 attempts of the standardised laparoscopic task slower than the control group that used traditional rigid needle holder (415 seconds vs 267 seconds taken for the first three attempts and 283 seconds vs 187 seconds taken for the last three attempts, respectively). The difference in average time for the first three and last three attempts reached statistical significance (P < 0.001). Furthermore, the intervention group demonstrated a higher error rate when compared to the control group (9.2 vs 6.3 errors per individual). Conclusions When compared to the FlexDex™, the traditional rigid needle holder was observed to be superior in task performance speed, leading to shorter completion times and quicker learning effect, as well as fewer errors.