A randomized clinical trial to evaluate transoral head and neck surgery using a single-port flexible robotic system

Abstract

This randomized IDEAL stage 2 clinical trials examined the safety and efficacy of a novel single-port flexible robot for transoral robotic surgery in patients with benign and malignant head and neck tumors. Rates of conversion and perioperative problems within a month of surgery were the main objectives. The Fisher's exact test and the Mann-Whitney U test were used in the statistical analysis, which used a p-value of 0.05 or less to determine significance. With the use of the da Vinci SP technology, 25 participants got TORS that allowed them to swiftly enter their nasopharynx, oropharynx, and hypopharynx. Notably, there were no serious complications or unfavorable robot-related occurrences throughout the 30-day follow-up period or any modifications to the robotic surgical equipment. The novel single-port flexible automated device demonstrates both security and practicality for carrying out transoral endoscopic procedures for head and neck conditions; based on this possible IDEAL stage 2 clinical trials, allowing accessibility to several anatomical regions, such as the larynx, oropharynx, nasopharynx, and hypopharynx.