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

Asit Arora; Jack Faulkner; Vinidh Paleri; Karan Kapoor; Ali Al-Lami; Oladejo Olaleye; Stuart Winter; Geogios Oikonomou; Enyi Ofo; Sebastien Ourselin; Prokar Dasgupta; Mark Slack; Jean-Pierre Jeannon

doi:10.1136/bmjsit-2022-000181

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

BMJ Surg Interv Health Technol. 2024 Mar 15;6(1):e000181. doi: 10.1136/bmjsit-2022-000181. eCollection 2024.

Authors

Asit Arora^{1

2}, Jack Faulkner^{1

2}, Vinidh Paleri³, Karan Kapoor⁴, Ali Al-Lami⁵, Oladejo Olaleye⁶, Stuart Winter⁷, Geogios Oikonomou⁸, Enyi Ofo⁸, Sebastien Ourselin¹, Prokar Dasgupta⁹, Mark Slack¹⁰, Jean-Pierre Jeannon²

Affiliations

¹ School of Biomedical Engineering and Imaging Sciences, King's College London, London, UK.
² Head and Neck Surgery, Guy's Hospital, London, UK.
³ Royal Marsden Hospital NHS Trust, London, UK.
⁴ Surrey and Sussex Healthcare NHS Trust, Redhill, Surrey, UK.
⁵ East Kent Hospitals University NHS Foundation Trust, Canterbury, Kent, UK.
⁶ Otolaryngology, Head and Neck Surgery, University Hospitals of Leicester NHS Trust, Leicester, UK.
⁷ Department of Surgical Sciences, University of Oxford Nuffield, Oxford, Oxfordshire, UK.
⁸ St George's University Hospitals NHS Foundation Trust, London, UK.
⁹ MRC Centre for Transplantation, NIHR Biomedical Research Centre, King's College, London, UK.
¹⁰ CMR Surgical Ltd, Cambridge, UK.

Abstract

Objectives: 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.

Design: IDEAL stage 0 preclinical assessment of the Versius Robotic System in TORS in human cadavers.

Setting: All procedures were performed in a simulated operating theatre environment at a UK surgical training centre.

Participants: 11 consultant head and neck surgeons from the UK, mainland Europe and the USA took part in TORS procedures on six human cadavers.

Interventions: 3 key index procedures were assessed that represent the core surgical workload of TORS: lateral oropharyngectomy, tongue base resection and partial supraglottic laryngectomy.

Main outcome measures: 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.

Results: 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.

Conclusions: 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.

Keywords: Device Evaluation; Ear Nose Throat Devices; Minimally Invasive Surgical Procedures; Robotic Surgical Procedures; Technology.