Chen Silu, Fan Shubo, Dong Jie, Chen Xu, Li Zhihua, Xie Yi, Wang Bing, Yang Kunlin, Tang Qi, Hao Han, Gu Yaming, Zhang Zheng, Zhang Kai, Ji Zhigang, Zhou Liqun, Xu Weifeng, Shen Cheng, Li Xuesong
Department of Urology, Peking University First Hospital, Institution of Urology, Beijing Key Laboratory of Urogenital Diseases (Male) Molecular Diagnosis and Treatment Center, National Urological Cancer Center, Peking University, Beijing, China.
Department of Urology, Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing, China.
J Endourol. 2025 Feb;39(2):114-120. doi: 10.1089/end.2024.0586. Epub 2025 Jan 24.
The KangDuo Surgical Robot-1500 (KD-SR-1500) is a newly developed surgical robot. We aim to evaluate the feasibility and efficiency of the KD-SR-1500 system for robot-assisted radical prostatectomy (RARP). This prospective, multicenter, single-arm clinical study was conducted among 18-75-year-old patients with suspected T1-2N0M0 prostate cancer scheduled for RARP. The perioperative and follow-up data were prospectively recorded. Early oncologic outcomes were assessed according to surgical margin status and prostate-specific antigen (PSA) at 6 weeks after surgery. Continence was defined as no more than one pad daily. Ergonomics were assessed with the National Aeronautics and Space Administration task load index (NASA-TLX). Perioperative complications were recorded according to the Clavien-Dindo classification. A total of 31 patients were involved in the trial. One patient with severe abdominal adhesion withdrew from the trial. All surgeries were performed successfully without any conversion or secondary surgery due to surgical complications. The median docking time and console time were 3.8 (3.3-5.2) and 104.6 (80.0-145.6) minutes, with a median estimated blood loss of 50 (20-100) mL. Positive surgical margin was observed in 6 (20%) patients. One (3.4%) patient experienced PSA persistence at 6 weeks after surgery. The urinary continence rate was 75.9% (22/29) at 4 weeks after catheter removal. There were no major complications (grade ≥ III) or equipment-related adverse events. The mean NASA-TLX score was 23.9 ± 11.7. The KD-SR-1500 is feasible and effective for the management of T1-T2 prostate cancer.
康多手术机器人-1500（KD-SR-1500）是一款新研发的手术机器人。我们旨在评估KD-SR-1500系统用于机器人辅助根治性前列腺切除术（RARP）的可行性和效率。这项前瞻性、多中心、单臂临床研究在计划接受RARP的18至75岁疑似T1-2N0M0前列腺癌患者中开展。前瞻性记录围手术期和随访数据。根据手术切缘状态和术后6周的前列腺特异性抗原（PSA）评估早期肿瘤学结局。控尿定义为每天使用不超过一片尿垫。使用美国国家航空航天局任务负荷指数（NASA-TLX）评估人体工程学。根据Clavien-Dindo分类记录围手术期并发症。共有31例患者参与试验。1例有严重腹部粘连的患者退出试验。所有手术均成功完成，未因手术并发症进行任何中转或二次手术。中位对接时间和控制台操作时间分别为3.8（3.3-5.2）分钟和104.6（80.0-145.6）分钟，中位估计失血量为50（20-100）mL。6例（20%）患者观察到手术切缘阳性。1例（3.4%）患者术后6周出现PSA持续存在。拔除导尿管后4周的尿控率为75.9%（22/29）。无严重并发症（≥III级）或与设备相关的不良事件。平均NASA-TLX评分为23.9±11.7。KD-SR-1500用于T1-T2期前列腺癌的治疗是可行且有效的。
