Evaluation of a Newly-developed Oral and Maxillofacial Surgical Robotic Platform (KD-SR-01) in Head and Neck Surgery: A Preclinical Trial in Porcine Models

Abstract

Robotic surgery is known as the "third technological revolution" in the field of surgery, and is an important milestone in the development of modern surgery. However, there is a notable absence of robots tailored specifically for head and neck surgery. In this study, we evaluated the feasibility, validity, and security of a newly-developed oral and maxillofacial robotic surgical platform in head and neck surgery, comparing it with a standard endoscopic system. Six healthy porcine models were randomly assigned to either the robotic group using KD-SR-01 or the endoscopic group. A single surgeon performed parotidectomy, submandibular gland resection, and neck dissection in both groups, collecting baseline characteristics, operative data, postoperative outcomes, and cognitive workload assessments. The results showed that all operations were completed successfully without any serious complications. The robotic group demonstrated a rapid average docking time of 5.50 ± 1.05 minutes for head and neck surgical procedures, with a total operative time of 88.00 ± 5.76 minutes, compared to 81.33 ± 7.81 minutes in the endoscopic group. Notably, the robotic group had significantly lower estimated blood loss and reduced cognitive workload on the surgeon and assistant. This study concludes that the newly-developed oral and maxillofacial surgical robotic system is technically feasible, safe, and valid for head and neck surgery, holding great promise for the future. However, further investigation through well-designed clinical trials with long-term follow-up is necessary to establish the full potential of this emerging robotic platform.