Prospective clinical trial to evaluate safety and feasibility of using a single port flexible robotic system for transoral head and neck surgery

Jason Y K Chan; Raymond K Tsang; F Christopher Holsinger; Michael C F Tong; Cherrie W K Ng; Philip W Y Chiu; Simon S M Ng; Eddy W Y Wong

doi:10.1016/j.oraloncology.2019.05.018

Prospective clinical trial to evaluate safety and feasibility of using a single port flexible robotic system for transoral head and neck surgery

Oral Oncol. 2019 Jul:94:101-105. doi: 10.1016/j.oraloncology.2019.05.018. Epub 2019 May 28.

Authors

Jason Y K Chan¹, Raymond K Tsang², F Christopher Holsinger³, Michael C F Tong⁴, Cherrie W K Ng⁴, Philip W Y Chiu⁵, Simon S M Ng⁵, Eddy W Y Wong⁴

Affiliations

¹ Department of Otorhinolaryngology, Head and Neck Surgery, The Chinese University of Hong Kong, Shatin, N.T., Hong Kong Special Administrative Region. Electronic address: jasonchan@ent.cuhk.edu.hk.
² Department of Surgery, The University of Hong Kong, Pok Fu Lam, Hong Kong Special Administrative Region.
³ Division of Head and Neck Surgery, Department of Otolaryngology, Stanford University, Palo, Alto, USA.
⁴ Department of Otorhinolaryngology, Head and Neck Surgery, The Chinese University of Hong Kong, Shatin, N.T., Hong Kong Special Administrative Region.
⁵ Department of Surgery, The Chinese University of Hong Kong, Shatin, N.T., Hong Kong Special Administrative Region.

PMID: 31178203
DOI: 10.1016/j.oraloncology.2019.05.018

Abstract

Introduction: The aim of this study was to determine the clinical safety and feasibility of a novel single-port flexible robot for Transoral Robotic Surgery (TORS).

Materials and methods: This was a prospective phase II / IDEAL stage 2 clinical trial of both benign and malignant lesions of the head and neck. The primary endpoint included conversion rates and perioperative complications within 30 days following surgery. The study was registered on www.ClinicalTrials.gov (NCT03010813). The Fisher's exact test and Mann-Whitney U test were used to compare categorical, and non-parametric data for the trial. A p value <0.05 was considered to be statistically significant. Statistical analysis was performed with SPSS 20.0 (IBM Corp., Armonk, New York) RESULTS: Twenty-one patients safely underwent TORS with the da Vinci SP (Intuitive Surgical Inc., Sunnyvale, CA) demonstrating the feasibility of access to the nasopharynx, oropharynx, larynx and hypopharynx. There were no conversions of the robotic surgical system. There were no serious adverse events or adverse events related to the use of the robot at 30-day follow-up for all patients.

Conclusions: In a prospective Phase II clinical trial, a novel single-port flexible robotic system appears safe and feasible to use for transoral endoscopic head and neck surgery to access the nasopharynx, oropharynx, larynx and hypopharynx.

Keywords: Clinical trial; Head and neck cancer; Robotic surgery; Single port; TORS; Transoral; Transoral robotic surgery.

Publication types

Research Support, Non-U.S. Gov't

MeSH terms

Adult
Aged
Clinical Trials, Phase II as Topic
Female
Head and Neck Neoplasms / mortality
Head and Neck Neoplasms / pathology
Head and Neck Neoplasms / surgery*
Humans
Laryngectomy / adverse effects
Laryngectomy / methods
Male
Middle Aged
Neoplasm Staging
Robotic Surgical Procedures / adverse effects
Robotic Surgical Procedures / methods*
Tonsillectomy

Associated data

ClinicalTrials.gov/NCT03010813