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
File(s) 05_Jan_2022_345140_Revised_Manuscript_Corrected.docx (56.47 KB)
Accepted version
Author(s)
Type
Journal Article
Abstract
Aims: 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.
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.
Date Issued
2022-02-04
Date Acceptance
2022-01-13
Citation
Medical Devices: Evidence and Research, 2022, 2022 (15), pp.15-25
ISSN
1179-1470
Publisher
Dove Medical Press
Start Page
15
End Page
25
Journal / Book Title
Medical Devices: Evidence and Research
Volume
2022
Issue
15
Copyright Statement
© 2022 Motahariasl et al. This work is published and licensed by Dove Medical Press Limited. The full terms of this license are available at https://www.dovepress.com/
terms.php and incorporate the Creative Commons Attribution – Non Commercial (unported, v3.0) License (http://creativecommons.org/licenses/by-nc/3.0/). By accessing
the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed.
For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms (https://www.dovepress.com/terms.php).
terms.php and incorporate the Creative Commons Attribution – Non Commercial (unported, v3.0) License (http://creativecommons.org/licenses/by-nc/3.0/). By accessing
the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed.
For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms (https://www.dovepress.com/terms.php).
License URL
Identifier
https://www.dovepress.com/assessment-of-an-articulating-laparoscopic-needle-holder-flexdex-compa-peer-reviewed-fulltext-article-MDER
Subjects
Science & Technology
Technology
Engineering, Biomedical
Engineering
laparoscopic skills
advanced bimanual skills
2D
FlexDex (TM)
INSTRUMENTS
2D
FlexDex™
advanced bimanual skills
laparoscopic skills
0903 Biomedical Engineering
1103 Clinical Sciences
Publication Status
Published
Date Publish Online
2022-02-04
