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

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.

Methods: 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 s versus 267 s taken for the first three attempts and 283 s versus 187 s 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 (9.3 versus 6.2 errors per individual).

Conclusion: 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.

Key statement: Traditional rigid needle holder leads to faster task completion times and lower error rates when compared with an articulating laparoscopic needle holder in 2D vision.