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.

Sutura laparoscópica mecanizada con FlexDex Surgical System® para ubicaciones anatómicamente difíciles / Robotic-like suturing with FlexDex Surgical System® for difficult laparoscopic suture

El campo de la cirugía laparoscópica ha experimentado un crecimiento exponencial en los últimos años. A pesar de los grandes avances en este campo, las herramientas laparoscópicas estándar no han logrado su desarrollo óptimo, presentando ciertas deficiencias en lo que a movilidad y ergonomía se refiere. La cirugía robótica ha intentado aportar soluciones a estos problemas, sin embargo, existen inconvenientes, entre los que se encuentran su elevado coste, escasa disponibilidad y la necesidad de capacitación específica, lo que condiciona su rentabilidad y generalización de uso. Presentamos los resultados de una serie clínica prospectiva de 20 casos, en los que se ha testado la seguridad, eficacia y ergonomía de FlexDex® para la realización de suturas intracorpóreas laparoscópicas. El resultado muestra una herramienta segura y funcional que ofrece control y precisión en su manejo, además de mejorar la ergonomía del cirujano. Este dispositivo supone una alternativa que combina la precisión y el rango de movimientos de la cirugía robótica, con la mayor disponibilidad de la laparoscopia convencional. (AU)

The field of laparoscopic surgery has experienced an exponential growth in recent years. Despite great progress in this field, standard laparoscopic tools have not been optimally developed and still has some deficiencies when it comes to mobility and ergonomics. Robotic surgery has attempted to solve these problems by improving the articulation of surgical instruments. However, it presents a series of disadvantages, among which are its high cost, low availability and the need of a specific training, which conditions its profitability and hinders a widespread use. We present the results of a prospective clinical series of 20 cases in which the safety, efficacy and ergonomics of FlexDex® have been tested for performing laparoscopic intracorporeal sutures. The result is a safe and functional tool that offers both control and precision in its handling, while improves the ergonomics of the surgeon. This device represents an alternative that combines the precision and range of movements of robotic surgery with the greater availability of conventional laparoscopy. (AU)

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.

Robotic-like suturing with FlexDex Surgical System® for difficult laparoscopic suture. / Sutura laparoscópica mecanizada con FlexDex Surgical System® para ubicaciones anatómicamente difíciles.

The field of laparoscopic surgery has experienced an exponential growth in recent years. Despite great progress in this field, standard laparoscopic tools have not been optimally developed and still has some deficiencies when it comes to mobility and ergonomics. Robotic surgery has attempted to solve these problems by improving the articulation of surgical instruments. However, it presents a series of disadvantages, among which are its high cost, low availability and the need of a specific training, which conditions its profitability and hinders a widespread use. We present the results of a prospective clinical series of 20 cases in which the safety, efficacy and ergonomics of FlexDex® have been tested for performing laparoscopic intracorporeal sutures. The result is a safe and functional tool that offers both control and precision in its handling, while improves the ergonomics of the surgeon. This device represents an alternative that combines the precision and range of movements of robotic surgery with the greater availability of conventional laparoscopy.