Ma Zhongkai, Guo Zhiyong, Cao Chang, He Jialu, Chen Su, Xia Hui, Li Chunjie, Zhu Guiquan
State Key Laboratory of Oral Diseases & National Center for Stomatology & National Clinical Research Center for Oral Diseases & Department of Head and Neck Oncology, West China Hospital of Stomatology, Sichuan University, Chengdu, China.
Gland Surg. 2025 Jul 31;14(7):1250-1262. doi: 10.21037/gs-2025-149. Epub 2025 Jul 28.
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.
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.
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.
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.
机器人手术对于头颈肿瘤患者而言是一场变革,达芬奇系统在这些手术中占据主导地位。本研究旨在评估一种新开发的机器人系统(康多手术机器人 - 1500,KD - SR - 1500)用于机器人辅助腮腺切除术和下颌下腺(SMG)切除术的可行性、安全性和有效性。
本前瞻性单臂临床研究于2023年11月至2024年1月在四川大学华西口腔医院进行。所有手术均由一名经验丰富的外科医生通过发际内入路使用KD - SR - 1500完成。前瞻性收集人口统计学、围手术期和随访数据。为进一步评估KD - SR - 1500用于腮腺切除术的安全性和可行性,我们纳入了一个历史对照组,该组患者于2021年至2023年在同一机构接受了内镜下腮腺切除术(EP)。
在这项前瞻性研究中,共有13例患者接受了腮腺切除术,3例患者接受了下颌下腺切除术。没有病例转为内镜手术或开放手术。所有机器人手术均成功完成,未观察到重大并发症。16例患者均未发生面神经损伤。经过倾向评分匹配后,纳入了9例接受机器人腮腺切除术(RP)的患者和28例接受EP的患者。两组的手术时间无显著差异。RP组的出血控制良好,平均失血量为10.00 mL,而EP组为47.86 mL。此外,机器人手术组在面神经保留方面表现更优,未报告有暂时性神经损伤,而内镜组有15例。
KD - SR - 1500系统已被证明是一种可行、安全且有效的工具,可用于进行腮腺切除术和下颌下腺切除术,支持其在机器人辅助头颈外科手术中的应用。