支持机器人泌尿外科手术的证据

D. K. Kim, K. Rha
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[4] performed a prospective, controlled, nonrandomized trial evaluating urinary incontinence and erectile dysfunction in a total of 14 centers in Sweden including 2,625 patients and concluded that RARP was beneficial in preserving erectile function compared with ORP, with no statistically significant differences in continence or surgical margins. \n \nIn an analysis of RPN, Choi et al. [5] performed a systematic review and meta-analysis of 23 studies and 2,240 patients. The authors concluded that RPN is more favorable than laparoscopic partial nephrectomy (LPN) in terms of a lower conversion rate to radical nephrectomy, more favorable renal function, a shorter length of hospital stay, and a shorter warm ischemia time. Potretzke and Bhayani [6] wrote an editorial comment on our previous article [5]. The authors mentioned the superior outcomes of RPN and the efficiency of excision and suturing. 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引用次数: 1

摘要

自从达芬奇手术系统(Intuitive surgical, Sunnyvale, CA, USA)问世以来,微创手术的趋势加速发展。其他机器人公司的其他平台也即将推出。多端口手术机器人ALF-X系统(SORAR SpA, Milan, Italy)最初被引入妇科手术,最近在机器人辅助部分肾切除术(RPN)的临床前动物研究中进行了评估[1,2]。ALF-X机器人由一个带有触觉手柄的遥控单元、一个三维高清监视器、一个红外眼球追踪系统和四个分离的机械臂组成。触觉反馈使外科医生能够感受到组织的力量和阻力。外科医生可以通过凝视来移动相机,该系统包括一套可重复使用的仪器。其他制造商包括Medrobotics (Raynham, MA, USA),该公司于2015年7月获得了美国食品和药物管理局的Flex机器人系统许可。Flex机器人系统为外科医生提供了难以到达的解剖位置的单点可视化访问。Titan Medical (Toronto, ON, Canada)是一家基于单孔机器人技术的上市公司。该系统采用一个25毫米的单通道端口,包含两个铰接仪器和一个三维高清摄像机。韩国国内制造企业Meree公司开发了REVO I机器人系统。为了补充全球市场,REVO I机器人计划进行临床试验。与此同时,韩国国家循证医疗保健合作机构(NECA)发表了一份关于机器人辅助根治性前列腺切除术(RARP)临床可行性和成本效益的初步报告,该报告来自五个大容量中心,为制定国家卫生政策提供基础数据。在肿瘤预后方面,两组生化复发率和手术切缘阳性率无显著差异。在功能方面,RARP显示,术后3个月和3年的完全尿失禁率最高,分别为88.7%和95.3%。关于机器人系统的成本分析,门槛为3050万韩元(韩元);27000美元(USD),对RARP、腹腔镜根治性前列腺切除术和开放式根治性前列腺切除术(ORP)三者之间的购买成本-效果分析显示,RARP尚不具有成本效益。如果能够减少830万韩元(约7400美元)的费用,RARP将是具有成本效益的。系统的有效性不能抵消成本,因为不同程序之间的有效性没有显著差异,RARP的机器人成本明显高于其他程序。然而,由于成本-效果分析所用的数据为1年的短期数据,需要进行长期的前瞻性研究以进一步进行高质量的分析。最近,高质量的证据正在出现,将机器人与传统对手进行比较。在一项关于RARP的研究中,Wallerstedt等人[3]在瑞典的14个中心进行了ORP与RARP的前瞻性比较试验,共包括2506名患者。该研究前瞻性地进行了3年,并对患者报告的结果进行了测量。RARP组围手术期出血少,住院时间短。ORP术后住院期间再手术及因心血管原因就诊的发生率较高。Haglind等人[4]在瑞典共14个中心进行了一项前瞻性、对照、非随机试验,评估尿失禁和勃起功能障碍,包括2,625名患者,结论是RARP与ORP相比有利于保持勃起功能,在尿失禁或手术边缘方面没有统计学上的显著差异。Choi等[5]在RPN分析中,对23项研究和2240例患者进行了系统回顾和荟萃分析。作者得出结论,RPN在向根治性肾切除术的转换率较低、肾功能较好、住院时间较短、热缺血时间较短等方面优于腹腔镜部分肾切除术(LPN)。Potretzke和Bhayani[6]对我们之前的文章[5]写了一篇社论评论。作者提到了RPN的良好效果和切除缝合的效率。RPN的真正价值在于其可行性、可及性和学习曲线,目前与RPN竞争的手术不是LPN,而是根治性肾切除术、消融和观察。将会有更多新的机器人平台,新的前瞻性随机数据将会出现。 韩国泌尿外科杂志希望继续分享机器人微创手术的最新进展,并加强机器人微创手术的未来前景。
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Supporting evidence for robotic urological surgery
Since the introduction of the da Vinci surgical system (Intuitive Surgical, Sunnyvale, CA, USA), the trend of minimally invasive surgery has accelerated. Recently, Intuitive Surgical launched the new da Vinci Xi platform and a prototype of a single-port surgical system. Other platforms from other robotic companies are on the horizon. The multiport surgical robotic ALF-X system (SORAR SpA, Milan, Italy) was initially introduced for gynecological surgery and was recently assessed in a preclinical animal study of robot-assisted partial nephrectomy (RPN) [1,2]. The ALF-X robot consists of a remote-controlled unit with a haptic handle, a three-dimensional high-definition monitor, an infrared eye-tracking system, and four detached robotic arms. The haptic feedback allows the surgeon to feel the force and resistance to the tissue. The surgeon can move the camera by gaze, and the system includes a large set of reusable instruments. Other manufacturers include Medrobotics (Raynham, MA, USA), which received U.S. Food and Drug Administration clearance for the Flex Robotic System in July 2015. The Flex Robotic System provides surgeons with single-site access visualization of hard-to-reach anatomical locations. Titan Medical (Toronto, ON, Canada) is a public company based on Single Port Orifice Robotic Technology. The system utilizes a 25-mm single-access port that contains two articulating instruments and a three-dimensional high-definition camera. The Korean domestic manufacturer Meree Company has developed the REVO I robot system. A clinical trial for the REVO I robot has been planned to supplement the global market. Meanwhile, the Korean national evidence-based health care collaborating agency (NECA) published a preliminary report on the clinical feasibility and cost-effectiveness of robot-assisted radical prostatectomy (RARP) from a total of five high-volume centers to provide fundamental data for instituting the national health policy. Concerning oncological outcomes, there were no significant differences in biochemical recurrence or the positive surgical margin rate. Concerning functional outcomes, RARP revealed the highest continence rate of 88.7% and 95.3% achievement of complete continence at postoperative 3 months and 3 years, respectively. Concerning cost analysis of the robotic system, with a threshold value of 30.5 million Korean won (KRW; 27,000 US dollars [USD]), a cost-effectiveness analysis of purchase among RARP, laparoscopic radical prostatectomy, and open radical prostatectomy (ORP) showed that RARP was not yet cost-effective. RARP could be cost-effective if the expenses could be reduced by 8.3 million KRW (7,400 USD). The effectiveness of the system could not offset the costs, because there was no significant difference in effectiveness among the different procedures, and the robotic cost of RARP was significantly more than that of the other procedures. However, owing to the short term of 1 year of data used for the cost-effectiveness analysis, long-term prospective study is necessary for further high-quality analysis. Recently, high-quality evidence is emerging comparing robotics with its traditional counterparts. In a study of RARP, Wallerstedt et al. [3] performed a prospective comparative trial of ORP versus RARP in a Swedish group of 14 centers including a total of 2,506 patients. The study was conducted prospectively over a 3-year period with patient-reported outcome measurement. The RARP group had less perioperative bleeding and shorter hospital stays. Reoperation during the hospital stay and seeking health care for cardiovascular reasons were more frequent after ORP. Haglind et al. [4] performed a prospective, controlled, nonrandomized trial evaluating urinary incontinence and erectile dysfunction in a total of 14 centers in Sweden including 2,625 patients and concluded that RARP was beneficial in preserving erectile function compared with ORP, with no statistically significant differences in continence or surgical margins. In an analysis of RPN, Choi et al. [5] performed a systematic review and meta-analysis of 23 studies and 2,240 patients. The authors concluded that RPN is more favorable than laparoscopic partial nephrectomy (LPN) in terms of a lower conversion rate to radical nephrectomy, more favorable renal function, a shorter length of hospital stay, and a shorter warm ischemia time. Potretzke and Bhayani [6] wrote an editorial comment on our previous article [5]. The authors mentioned the superior outcomes of RPN and the efficiency of excision and suturing. The true value of RPN is in its feasibility, accessibility, and learning curves, and the procedure competing with RPN now is not LPN, but rather radical nephrectomy, ablation, and observation. There will be more new robotic platforms, and new prospective randomized data will become available. The Korean Journal of Urology hopes to continue to share this knowledge on recent updates in robotic minimally invasive surgery and to enhance future perspectives on robotic minimally invasive surgery.
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