Department of Colorectal Cancer Surgery, The Second Affiliated Hospital of Harbin Medical University, Harbin.
Department of Gastrointestinal Surgery, The First Affiliated Hospital of Chongqing Medical University, Chongqing.
Int J Surg. 2024 Mar 1;110(3):1511-1518. doi: 10.1097/JS9.0000000000000976.
BACKGROUND: Robotic surgery has been a revolution for colon cancer (CC) patients, with the increasing availability of different competitive robotic systems, but evidence of relevant oncologic outcomes is indeed scarce. Our goal was to compare the surgical quality and short-term oncologic outcomes of the Kangduo Surgical Robotic System and the da Vinci Si Robotic System in patients with CC. METHODS: These are results from a subcohort of a multicenter randomized controlled noninferiority trial performed in three centers in China. Enrolled patients were randomly assigned to undergo surgery using either the KD-SR-01 system (KD group) or the da Vinci Si (DV) robotic system (DV group). Neither investigators nor patients were masked to treatment allocation, but assessment of pathological outcomes was masked to treatment allocation. The primary endpoint was surgical success rate. The secondary endpoints were surgical outcomes, pathologic outcomes, and postoperative outcomes. The study is registered at www.chictr.org.cn (ChiCTR2200063172). Although the long-term follow-up results were not a predefined endpoint for this study, late-stage work is in progress. RESULTS: A total of 58 CC patients were included in this study, 28 in the KD group and 30 in the DV group. All patients were successfully operated without any intermediate open/conventional laparoscopic surgery and the success rate of surgery was 100%. Assessment of equipment docking task load and intraoperative operating sensation score were similar between the two groups. Adverse events and Clavien-Dindo grade II or higher grade complication rates were comparable between the two groups. Device arm docking time, robotic arm operation time, and intraoperative bleeding were not significantly different between the two groups. Similar results were obtained from postoperative pathological outcomes and internal environment indexes. CONCLUSIONS: The efficacy and safety of the Kangduo Robotic Surgical System has been proved, operation of the Kangduo Robotic System by experienced surgeons for CC is not less effective than the da Vinci robotic System.
背景：机器人手术为结肠癌（CC）患者带来了一场革命，不同竞争的机器人系统的可用性不断增加，但相关肿瘤学结果的证据确实很少。我们的目标是比较康多手术机器人系统和达芬奇 Si 机器人系统在 CC 患者中的手术质量和短期肿瘤学结果。
方法：这是在中国三个中心进行的多中心随机对照非劣效性试验的亚组结果。纳入的患者被随机分配接受 KD-SR-01 系统（KD 组）或达芬奇 Si（DV）机器人系统（DV 组）手术。调查人员和患者均未对治疗分配进行掩盖，但病理结果评估对治疗分配进行了掩盖。主要终点是手术成功率。次要终点是手术结果、病理结果和术后结果。该研究在中国临床试验注册中心（ChiCTR2200063172）注册。尽管长期随访结果不是本研究的预定终点，但后期工作正在进行中。
结果：共有 58 例 CC 患者纳入本研究，KD 组 28 例，DV 组 30 例。所有患者均成功完成手术，无中间开腹/传统腹腔镜手术，手术成功率为 100%。两组设备对接任务负荷和术中操作感觉评分评估相似。两组不良事件和 Clavien-Dindo Ⅱ级或更高级别的并发症发生率相似。两组设备臂对接时间、机器人臂操作时间和术中出血无显著差异。术后病理结果和内部环境指标也得到了类似的结果。
结论：康多机器人手术系统的疗效和安全性已得到证实，经验丰富的外科医生操作康多机器人系统治疗 CC 的效果不亚于达芬奇机器人系统。
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Zotero 插件
