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《康多手术机器人-01 系统辅助腹腔镜根治性肾输尿管切除术:一项前瞻性、单中心、单臂临床研究》

Robot-Assisted Radical Nephroureterectomy Using the KangDuo-Surgical Robot-01 System: A Prospective, Single-Center, Single-Arm Clinical Study.

机构信息

Department of Urology, Peking University First Hospital, Institute of Urology, Peking University, National Urological Cancer Center, Beijing, China.

出版信息

J Endourol. 2024 Jul;38(7):661-667. doi: 10.1089/end.2023.0758. Epub 2024 Jul 1.

DOI:10.1089/end.2023.0758
PMID:38623792
Abstract

To investigate the feasibility, safety, and efficacy of the KangDuo-Surgical Robot-01 (KD-SR-01) system for robot-assisted radical nephroureterectomy (RARNU). This prospective, single-center, single-arm clinical study of patients with upper tract urothelial carcinoma (UTUC) was conducted from August 2022 to July 2023 using the KD-SR-01 system. The perioperative and follow-up data were prospectively recorded. The National Aeronautics and Space Administration task load index was calculated to present ergonomics. The technique was described in detail. A total of 13 patients underwent RARNU. None of the cases conversed to laparoscopic procedure or open procedure. The median docking time and console time were 524 seconds (range 139-963 seconds) and 102.2 minutes (range 55.3-249.3 minutes), respectively. The median estimated blood loss was 40 mL (range 10-100 mL). None of the patients required intraoperative blood transfusion. The median postoperative hospital stay was 4 days (range 2-7 days). Intraoperative or postoperative complications (Clavien-Dindo grade I) occurred in nine patients. The surgeon task load index global score achieved 1.05 ± 1.86. Three patients received the single-docking technique, demonstrating similar perioperative results compared with patients with redocking. The study is registered at www.chictr.org.cn (ChiCTR2200056672). The KD-SR-01 system was feasible, safe, and effective for RARNU.

摘要

研究 KangDuo-Surgical Robot-01(KD-SR-01)系统用于机器人辅助根治性肾输尿管切除术(RARNU)的可行性、安全性和有效性。这项前瞻性、单中心、单臂临床研究于 2022 年 8 月至 2023 年 7 月使用 KD-SR-01 系统对患有上尿路尿路上皮癌(UTUC)的患者进行。前瞻性记录围手术期和随访数据。使用美国国家航空航天局任务负荷指数来呈现人机工程学。详细描述了该技术。共 13 例患者接受了 RARNU。无 1 例患者转为腹腔镜手术或开放手术。中位对接时间和控制台时间分别为 524 秒(范围 139-963 秒)和 102.2 分钟(范围 55.3-249.3 分钟)。中位估计出血量为 40 mL(范围 10-100 mL)。无 1 例患者需要术中输血。中位术后住院时间为 4 天(范围 2-7 天)。9 例患者发生术中或术后并发症(Clavien-Dindo 分级 I)。外科医生任务负荷指数总分为 1.05±1.86。3 例患者采用单对接技术,与重新对接患者的围手术期结果相似。该研究在 www.chictr.org.cn(ChiCTR2200056672)注册。KD-SR-01 系统用于 RARNU 是可行、安全和有效的。

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