Medical Devices: Evidence and Research (Feb 2022)

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

  • Motahariasl N,
  • Farzaneh SB,
  • Motahariasl S,
  • Kokotkin I,
  • Sousi S,
  • Zargaran A,
  • Zargaran D,
  • Bijendra Patel

Journal volume & issue
Vol. Volume 15
pp. 15 – 25

Abstract

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Nima Motahariasl,1 Sayed Borna Farzaneh,1 Sina Motahariasl,2 Ilya Kokotkin,3 Sara Sousi,4,5 Alexander Zargaran,5,6 David Zargaran,7 Bijendra Patel8 1St George’s Hospital NHS Trust, London, SW17 0QT, UK; 2Lewisham and Greenwich NHS Trust, London, SE13 6LH, UK; 3St George’s University of London, London, SW17 0RE, UK; 4Department of Surgery and Cancer, Imperial College London, Hammersmith Campus, London, W12 0NN, UK; 5King’s College London, London, SE1 1UL, Greater London, UK; 6Chelsea and Westminster Hospital, London, SW10 9NH, UK; 7Royal Free Hospital, London, NW3 2QG, UK; 8Barts Cancer Institute, Queen Mary University of London, London, UKCorrespondence: Sara SousiDepartment of Surgery and Cancer, Imperial College London, Hammersmith Campus, London, W12 0NN, UK, Email [email protected]: 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.Keywords: laparoscopic skills, advanced bimanual skills, 2D, FlexDex™

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