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DOI: 10.1055/a-2297-3647
A Handheld Robot for Endoscopic Endonasal Skull Base Surgery: Updated Preclinical Validation Study (IDEAL Stage 0)
Funding Dr. Starup-Hansen, Dr. Newall, Dr. Khan, Dr. Hanrahan, Dr. Sinha, Dr. Booker, Dr. Marcus, and Dr. Dimitrios Psychogyios are supported by the Wellcome (203145Z/16/Z) /EPSRC (NS/A000050/1) Centre for Interventional and Surgical Sciences, University College London. Dr. Marcus is also funded by the NIHR Biomedical Research Centre at University College London. Dr. Khan and Dr. Hanrahan are supported by the NIHR Academic Clinical Fellowships. Prof. Stoyanov is supported by a Royal Academy of Engineering Chair in Emerging Technologies and an EPSRC Early Career Research Fellowship. Dr. Dimitrakakis, Dr. Dwyer, Dimitrios Psychogyios, and Keshav Iyengar are funded by Panda Surgical Limited. Mr. Marcus, Prof. Stoyanov, and Dr. Dimitrakakis hold shares in Panda Surgical Limited.Dr. Dimitrios Psychogyios, Dr. Danyal Khan, Dr. Emmanouil Dimitrakakis, Dr. Hani Marcus, Dr. James Booker, Dr. John Hanrahan, Dr. Joachim Starup-Hansen, Dr. Keshav Iyengar, Dr. Nicola Newall, Dr. Siddharth Sinha reported payments made to the institution/person by University College London Hospital NHS Foundation Trust.Dr. Emmanouil Dimitrakakis, Dr. Hani Marcus, Dr. Danail Stoyanov reported patents related to “End-effector for endoscopic surgical instrument.”Dr. Hani Marcus is supported by the UCLH/UCL Biomedical Research Centre Neuroscience.Dr. Danail Stoyanov reported: grants: Wellcome Trust, UKRI, European Commission, RAEng; employment: Digital Surgery Ltd (Medtronic); participation on IHU Scientific Advisory Board and AT-NCIGT; hold shares in Odin Vision Ltd (Olympus).
Abstract
Background and Objectives Endoscopic endonasal surgery (EES) has become increasingly popular, yet anatomical constraints posed by the nose and limitations of nonarticulated instruments render EES technically challenging, with a steep associated learning curve. Therefore, we developed a handheld robot to enhance dexterity in endoscopic neurosurgical procedures. A previous trial of the robot demonstrated its potential advantages in endoscopic neurosurgery but also the need for improvements. In this study, we assess the feasibility, acceptability, and comparative performance of the updated robotic prototype (version 0.2) against standard instruments in a preclinical phantom and cadaveric trial.
Methods Ethical approval was received. Participants were stratified according to their neurosurgical experience. In the phantom study, a randomized crossover design compared the robot against standard instruments at a phantom tumor resection task. Statistical analysis was performed using Mann–Whitney U tests and paired t-tests. In the cadaver-based user study, participants evaluated the device's functional domains through a qualitative interview design.
Results In the phantom study, the device demonstrated a learning curve: initial resection attempts favored the traditional instrument (84% vs. 59%, p = 0.055), but parity was achieved by the fifth attempt (80% vs. 83%, p = 0.76). Acceptability was evident, as most clinicians (7/8) preferred the robot for its superior range, ergonomics, and precision. Also, the robot exhibited a diminished cognitive workload. The cadaveric study underscored the robot's clinical feasibility, through sufficient workspace reach and force delivery.
Conclusion: Overall, our robot demonstrates promising acceptability and feasibility for endoscopic neurosurgery, yet further iterative developments are required before proceeding to in-human clinical trials.
* First author equal contribution.
# Senior author equal contribution.
Publication History
Received: 19 October 2023
Accepted: 09 March 2024
Accepted Manuscript online:
01 April 2024
Article published online:
15 April 2024
© 2024. The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/)
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