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.

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.

Evaluation of Advanced Bimanual Skills in Novices Using the Wrist-Like FlexDex™ Articulating Laparoscopic Needle Holder in 2D and 3D Vision: A Randomised Trial.

AIM: The aim of this study was to evaluate the novice performance of advanced bimanual laparoscopic skills using the articulating FlexDexTM laparoscopic needle holder in two-dimensional (2D) and three-dimensional (3D) visual systems. METHODS: In this prospective randomised trial, novices (n=40) without laparoscopic experience were recruited from a university cohort and randomised into two groups, which used the FlexDexTM and 2D or the FlexDex™ and 3D. Both groups performed 10 repetitions of a validated assessment task. Times taken and error rates were measured, and assessments were made based on completion times, error rates and learning curves. RESULTS: The intervention group that used FlexDexTM and 3D visual output completed 10 attempts of the standardised laparoscopic task quicker than the control group that used FlexDexTM with standard 2D visual output (268 seconds vs 415 seconds taken for the first three attempts and 176 seconds vs 283 seconds taken for the last three attempts, respectively). Moreover, each attempt was completed faster by the intervention group compared to the control group. The difference in average time for the first three and last three attempts reached statistical significance (P < 0.001). CONCLUSION: Combination of 3D visual systems and the FlexDexTM laparoscopic needle holder resulted in superior task performance speed, leading to shorter completion times and quicker learning effect. Although the 3D group demonstrated lower mean error rates, it did not reach statistical significance. KEY STATEMENT: 3D visual systems lead to faster task completion times when combined with an articulating laparoscopic needle holder compared to 2D vision. This effect however is not seen in error rates.