Prospective clinical trial to evaluate safety and feasibility of using a single port flexible robotic system for transoral head and neck surgery. (July 2019)

• Record Type: Journal Article
• Authors: Chan, Jason Y.K.; Tsang, Raymond K.; Holsinger, F. Christopher; Tong, Michael C.F.; Ng, Cherrie W.K.; Chiu, Philip W.Y.; Ng, Simon S.M.; Wong, Eddy W.Y.
• Is Part Of: Oral oncology. Volume 94(2019)
• Page Start: 101
• Page End: 105
• Publication Date: 2019-07
• Subjects: Robotic surgery -- Single port -- Transoral robotic surgery -- TORS -- Clinical trial -- Transoral -- Head and neck cancer; Mouth -- Cancer -- Periodicals; Mouth -- Tumors -- Periodicals; Mouth Diseases -- Periodicals; Mouth Neoplasms -- Periodicals; Bouche -- Cancer -- Périodiques; Bouche -- Tumeurs -- Périodiques; Tumeurs -- Périodiques; Electronic journals; 616.9943105
• DOI: 10.1016/j.oraloncology.2019.05.018
• Languages: English
• ISSNs: 1368-8375

Abstract

Highlights: A phase II clinical trial of a novel single-port flexible robot for TORS. TORS of the nasopharynx/oropharynx/larynx/hypopharynx was safe and feasible. No serious adverse event or adverse events related to the robot at 30-day follow-up. Improved visualization/maneuverability for TORS of the upper aerodigestive tract. 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 onwww.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.