New robotic platform for transoral robotic surgery: an IDEAL stage 0 study.

Device Evaluation Ear Nose Throat Devices Minimally Invasive Surgical Procedures Robotic Surgical Procedures Technology

Journal

BMJ surgery, interventions, & health technologies
ISSN: 2631-4940
Titre abrégé: BMJ Surg Interv Health Technol
Pays: England
ID NLM: 101764673

Informations de publication

Date de publication:
2024
Historique:
received: 04 01 2023
accepted: 28 11 2023
medline: 19 3 2024
pubmed: 19 3 2024
entrez: 19 3 2024
Statut: epublish

Résumé

This study aims to assess the feasibility to perform transoral robotic surgery (TORS) with a new robotic platform, the Versius Surgical System (CMR Surgical, UK) in a preclinical cadaveric setting in accordance to stage 0 of the IDEAL-D framework. IDEAL stage 0 preclinical assessment of the Versius Robotic System in TORS in human cadavers. All procedures were performed in a simulated operating theatre environment at a UK surgical training centre. 11 consultant head and neck surgeons from the UK, mainland Europe and the USA took part in TORS procedures on six human cadavers. 3 key index procedures were assessed that represent the core surgical workload of TORS: lateral oropharyngectomy, tongue base resection and partial supraglottic laryngectomy. The primary outcome was the successful completion of each surgical procedure. Secondary outcomes included the optimisation of system setup, instrumentation and surgeon-reported outcomes for feasibility of each component procedural step. 33 cadaveric procedures were performed and 32 were successfully completed. One supraglottic laryngectomy was not fully completed due to issues dividing the epiglottic cartilage with available instrumentation. Surgeon-reported outcomes met the minimal level of feasibility in all procedures and a consensus that it is feasible to perform TORS with Versius was reached. Available instrumentation was not representative of other robotic platforms used in TORS and further instrument optimisation is recommended before wider dissemination. It is feasible to perform TORS with the Versius Surgical System (CMR Surgical) within a pre-clinical cadaveric setting. Clinical evaluation is needed and appropriate with the system. Further instrument development and optimisation is desirable.

Identifiants

pubmed: 38500710
doi: 10.1136/bmjsit-2022-000181
pii: bmjsit-2022-000181
pmc: PMC10946345
doi:

Types de publication

Journal Article

Langues

eng

Pagination

e000181

Informations de copyright

© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Déclaration de conflit d'intérêts

Competing interests: This study was funded by CMR Surgical Ltd. including providing access to laboratory space, cadavers and the robotic system. Mark Slack is a co-founder and current chief medical officer of CMR Surgical.

Auteurs

Asit Arora (A)

School of Biomedical Engineering and Imaging Sciences, King's College London, London, UK.
Head and Neck Surgery, Guy's Hospital, London, UK.

Jack Faulkner (J)

School of Biomedical Engineering and Imaging Sciences, King's College London, London, UK.
Head and Neck Surgery, Guy's Hospital, London, UK.

Vinidh Paleri (V)

Royal Marsden Hospital NHS Trust, London, UK.

Karan Kapoor (K)

Surrey and Sussex Healthcare NHS Trust, Redhill, Surrey, UK.

Ali Al-Lami (A)

East Kent Hospitals University NHS Foundation Trust, Canterbury, Kent, UK.

Oladejo Olaleye (O)

Otolaryngology, Head and Neck Surgery, University Hospitals of Leicester NHS Trust, Leicester, UK.

Stuart Winter (S)

Department of Surgical Sciences, University of Oxford Nuffield, Oxford, Oxfordshire, UK.

Geogios Oikonomou (G)

St George's University Hospitals NHS Foundation Trust, London, UK.

Enyi Ofo (E)

St George's University Hospitals NHS Foundation Trust, London, UK.

Sebastien Ourselin (S)

School of Biomedical Engineering and Imaging Sciences, King's College London, London, UK.

Prokar Dasgupta (P)

MRC Centre for Transplantation, NIHR Biomedical Research Centre, King's College, London, UK.

Mark Slack (M)

CMR Surgical Ltd, Cambridge, UK.

Jean-Pierre Jeannon (JP)

Head and Neck Surgery, Guy's Hospital, London, UK.

Classifications MeSH