Peking Union Medical College Reports Findings in Surgical Technology (Robot-assi sted Radical Prostatectomy with the KangDuo Surgical System Versus the da Vinci Si System: A Prospective, Double-center, Randomized Controlled Trial)
Peking Union Medical College Reports Findings in Surgical Technology (Robot-assi sted Radical Prostatectomy with the KangDuo Surgical System Versus the da Vinci Si System: A Prospective, Double-center, Randomized Controlled Trial)
由新闻记者-机器人与机器学习的工作人员新闻编辑每日新闻-外科新研究-外科技术是一篇报道的主题。根据NewsRx记者在北京的新闻报道,研究表明:“康铎手术机器人(KD-SR)是一种新开发的手术机器人,比较机器人辅助根治性前列腺切除术(RARP)与达芬奇手术系统(DV-SS-Si)的安全性和有效性。”新闻记者引用北京协和医学院的一篇研究报道:“在18-75岁疑似T1-2N0M0前列腺癌(PCa)行RARP的患者中,进行了一项前瞻性双中心非劣效性随机对照试验,用KD-SR(KD-RARP)进行RARP,用DV-SI(DV-RARP)进行RARP。主要结果是手术成功,定义为:手术可以按照既定方案进行。”无需改变其他手术方式,术后因外科并发症而不需再次手术,次要结果为短期功能和肿瘤学结果,非劣效性阈值设为10%,共纳入80例患者,平均年龄2岁。结果79例患者(KD-RARP组40例,DV-RARP组39例)尿控率均为100%,两组尿控率在1、2、3、6个月无明显差异。KD-RARP组和DV-RARP组II级不良事件发生率分别为20%和17.9%(P=0.82),未发生II级不良事件,KD-RARP组中位手术时间明显长于DV-RARP组(177.5 vs 145 min)。主要限制因素是随访期短,生存不被视为主要结局。KD-SR是RARP的可行选择,与T1-2 PCa的DV-SI相比,短期结局可接受。
Abstract
By a News Reporter-Staff News Editor at Robotics & Machine Learning Daily News Daily News-New research on Surgery-Surgical Tec hnology is the subject of a report. According to news reporting from Beijing, Pe ople's Republic of China, by NewsRx journalists, research stated, "The KangDuo S urgical Robot (KD-SR) is a newly developed surgical robot. To compare the safety and efficacy of robot-assisted radical prostatectomy (RARP) using the KD-SR wit h those of the da Vinci Si Surgical System (DV-SS-Si)." The news correspondents obtained a quote from the research from Peking Union Med ical College, "A prospective double-center noninferiority randomized controlled trial was conducted among 18-75-yr-old patients with suspected T1-2N0M0 prostate cancer (PCa) scheduled for RARP. RARP with the KD-SR (KD-RARP) versus RARP with the DV-SS-Si (DV-RARP). The primary outcome was surgical success, defined as fo llows: surgery can be performed according to the established protocol, without s witching to other surgical modalities, and without secondary surgery due to surg ical complications after surgery. The secondary outcome was short-term functiona l and oncological outcomes. The noninferiority threshold was set at 10% . Eighty patients were enrolled, while the full analysis set finally included 79 patients (40 with KD-RARP and 39 with DV-RARP). The success rate was 100% in both groups. We could not find differences in urinary continence rate at 1, 2 , 3, and 4 wk after catheter removal between the groups (p > 0.05). The rate of Clavien-Dindo grade II adverse events was 20% in the KD-RARP group and 17.9 % in the DV-RARP group (p = 0.82), an d no grade III adverse events occurred. The median operation time was significan tly longer in the KD-RARP group than in the DV-RARP group (177.5 vs 145 min, p = 0.012). The main limitations were the short follow-up period and that survival was not considered as the primary outcome. The KD-SR is a viable option for RARP , with acceptable short-term outcomes compared with the DV-SS-Si for T1-2 PCa."
Key words
Beijing/People's Republic of China/Asi a/Clinical Research/Clinical Trials and Studies/Emerging Technologies/Health and Medicine/Machine Learning/Male Urologic Surgical Procedures/Medical Devi ces/Men's Health/Prostatectomy/Robot/Robotics/Surgery/Surgical System/Sur gical Technology