Zhang Lin, Zhou Huiqin, Wen Zhiyong, Zheng Hang, Yang Kun, Wang Xinghuan
Second Clinical College, Hospital of Wuhan University, Wuhan, China.
Department of Urology, Zhongnan Hospital, Wuhan University, Wuhan, China.
J Endourol. 2025 Apr;39(4):375-380. doi: 10.1089/end.2024.0822. Epub 2025 Mar 19.
To determine the feasibility and safety of a new domestic single-port surgical robot in urologic partial nephrectomy and radical prostatectomy, as measured by the primary metric outcome (surgical success rate). In addition, this study measured important perioperative surgical outcomes, such as operative time, blood loss, postoperative length of stay, docking time, and thermal ischemia time, and reported pathologic data using the surgical robot. This prospective, single-center, single-group clinical study was conducted between August 2023 and October 2023. One surgeon used a new domestic single-port surgical robot (EDGE SP1000) to perform six urologic procedures, including three partial nephrectomies and three extraperitoneal radical prostatectomies. Perioperative data were prospectively recorded, early oncologic outcomes were assessed based on the surgical margin status, and equipment ergonomic comfort was assessed using the National Aeronautics and Space Administration Task Load Index (NASA-TLX). All six procedures were effectively completed without conversion to open surgery, laparoscopy, or use of multiport robots. The average total operation time was 207.92 ± 32.42 minutes, estimated blood loss was 100 mL (10-900 mL), and postoperative hospital stay was 8.67 ± 1.33 days. The average docking time was 16.25 ± 5.68 minutes, and warm ischemia time was 17.00 ± 2.65 minutes. None of the patients required perioperative blood transfusion. All pathologic examination margins were negative. No serious perioperative complications occurred (Clavien-Dindo grade 3). The surgeon reported that the device was comfortable to use, with a NASA-TLX score of 35.67 ± 4.23. It is safe and feasible to perform urologic procedure using the EDGE single-port endoscopic surgical robot (EDGE SP1000) control system.
以主要指标结果（手术成功率）衡量，确定一款新型国产单孔手术机器人在泌尿外科部分肾切除术和根治性前列腺切除术中的可行性和安全性。此外，本研究还测量了重要的围手术期手术结果，如手术时间、失血量、术后住院时间、对接时间和热缺血时间，并报告了使用手术机器人的病理数据。这项前瞻性、单中心、单组临床研究于2023年8月至2023年10月进行。一名外科医生使用一款新型国产单孔手术机器人（EDGE SP1000）进行了6例泌尿外科手术，包括3例部分肾切除术和3例腹膜外根治性前列腺切除术。前瞻性记录围手术期数据，根据手术切缘状态评估早期肿瘤学结果，并使用美国国家航空航天局任务负荷指数（NASA-TLX）评估设备的人体工程学舒适度。所有6例手术均有效完成，未转为开放手术、腹腔镜手术或使用多端口机器人。平均总手术时间为207.92±32.42分钟，估计失血量为100 mL（10 - 900 mL），术后住院时间为8.67±1.33天。平均对接时间为16.25±5.68分钟，热缺血时间为17.00±2.65分钟。所有患者均无需围手术期输血。所有病理检查切缘均为阴性。未发生严重围手术期并发症（Clavien-Dindo 3级）。外科医生报告该设备使用舒适，NASA-TLX评分为35.67±4.23。使用EDGE单孔内镜手术机器人（EDGE SP1000）控制系统进行泌尿外科手术是安全可行的。
