Evaluation of a new developed robotic system for head and neck surgery: a prospective study.

Abstract

Background: Robotic surgery has been a revolution for head and neck tumor patients, with the da Vinci system predominating these procedures. This study aims to evaluate the feasibility, safety, and effectiveness of a newly developed robotic system (KangDuo Surgical Robot-1500, KD-SR-1500) for robotic-assisted parotidectomy and submandibular gland (SMG) resection.

Methods: This prospective, single-arm clinical study was conducted from November 2023 to January 2024 at the West China Hospital of Stomatology, Sichuan University. All operations were performed using the KD-SR-1500 via a trans-hairline approach by one experienced surgeon. Demographic, perioperative, and follow-up data were prospectively collected. To further assess the safety and feasibility of the KD-SR-1500 for parotidectomy, we included a historical control group of patients who underwent endoscopic parotidectomy (EP) at the same institution between 2021 and 2023.

Results: A total of 13 patients underwent parotidectomy and three underwent SMG resection in this prospective study. No cases were converted to endoscopic or open surgery. All robotic procedures were completed successfully, without significant complications observed. None of the 16 patients suffered from facial nerve injury. After propensity score matching, nine patients who underwent robotic parotidectomy (RP) and 28 patients who underwent EP were included. The operation time was not significantly different between the two groups. The RP group demonstrated excellent bleeding control, with an average blood loss of 10.00 mL compared to 47.86 mL in the EP group. Additionally, the robotic group showed superior facial nerve preservation, with no temporary nerve injuries reported, compared to 15 cases in the endoscopic group.

Conclusions: The KD-SR-1500 system has been proven to be a feasible, safe, and effective tool for performing parotidectomy and SMG resection, supporting its utility in robotic-assisted head and neck surgery.