Department of Urology, Peking University First Hospital, Institute of Urology, Peking University, National Urological Cancer Center, Beijing, China.
Department of Urology, Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing, China.
Int Braz J Urol. 2024 Nov-Dec;50(6):727-736. doi: 10.1590/S1677-5538.IBJU.2024.0230.
INTRODUCTION: We aim to compare the safety and effectiveness of the KangDuo (KD)-Surgical Robot-01 (KD-SR-01) system and the da Vinci (DV) system for robot-assisted radical nephroureterectomy (RARNU). MATERIALS AND METHODS: This multicenter prospective randomized controlled trial was conducted between March 2022 and September 2023. Group 1 included 29 patients undergoing KD-RARNU. Group 2 included 29 patients undergoing DV-RARNU. Patient demographic and clinical characteristics, perioperative data, and follow-up outcomes were collected prospectively and compared between the two groups. RESULTS: There were no significant differences in patient baseline demographic and preoperative characteristics between the two groups. The success rates in both groups were 100% without conversion to open or laparoscopic surgery or positive surgical margins. No significant difference was observed in docking time [242 (120-951) s vs 253 (62-498) s, P = 0.780], console time [137 (55-290) min vs 105 (62-220) min, P = 0.114], operative time [207 (121-460) min vs 185 (96-305) min, P = 0.091], EBL [50 (10-600) mL vs 50 (10-700) mL, P = 0.507], National Aeronautics and Space Administration Task Load Index scores, and postoperative serum creatinine levels between the two groups. None of the patients showed evidence of distant metastasis, local recurrence, or equipment-related adverse events during the four-week follow-up. One (3.4%) patient in Group 2 experienced postoperative enterovaginal and enterovesical fistulas (Clavien-Dindo grade III). CONCLUSIONS: The KD-SR-01 system is safe and effective for RARNU compared to the DV Si or Xi system. Further randomized controlled studies with larger sample sizes and longer durations are required.
介绍:本研究旨在比较康多(KD)-手术机器人-01(KD-SR-01)系统与达芬奇(DV)系统用于机器人辅助根治性肾输尿管切除术(RARNU)的安全性和有效性。
材料与方法:本多中心前瞻性随机对照试验于 2022 年 3 月至 2023 年 9 月进行。组 1 纳入 29 例行 KD-RARNU 的患者,组 2 纳入 29 例行 DV-RARNU 的患者。前瞻性收集两组患者的人口统计学和临床特征、围手术期数据和随访结果,并进行比较。
结果:两组患者的基线人口统计学和术前特征无显著差异。两组的成功率均为 100%,无中转开放或腹腔镜手术或切缘阳性。两组的对接时间[242(120-951)s 比 253(62-498)s,P=0.780]、控制台时间[137(55-290)min 比 105(62-220)min,P=0.114]、手术时间[207(121-460)min 比 185(96-305)min,P=0.091]、术中出血量[50(10-600)mL 比 50(10-700)mL,P=0.507]、美国国家航空航天局任务负荷指数评分和术后血清肌酐水平均无显著差异。在四周的随访期间,两组患者均无远处转移、局部复发或设备相关不良事件的证据。组 2 中有 1 例(3.4%)患者发生术后肠阴道瘘和肠膀胱瘘(Clavien-Dindo 分级 III 级)。
结论:KD-SR-01 系统用于 RARNU 的安全性和有效性与 DV Si 或 Xi 系统相当。需要进一步开展更大样本量和更长随访时间的随机对照研究。
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