机器人手术;进入公共场所的时代

Yong Beom Kim
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Recently, the US Food and Drug Administration cautioned against the use of robotic surgery in cancer operations, stating that “survival benefits to patients when compared to traditional surgery have not been established” after phase III Laparoscopic Approach to Cervical Cancer (LACC) trial. This phase III trial was designed for the definitive comparison of survival outcomes of radical hysterectomy in patients with early stage cervical cancer between minimally invasive surgery (MIS) and open procedure. This trial demonstrated that MIS is associated with lower rates of disease-free survival and overall survival than open procedure [2]. The findings of this LACC trial are consistent with those of a retrospective study based on the data from the Surveillance, Epidemiology, and End Results (SEER) program database of National Cancer Database (NCDB) for the year of 2000–2010 period [3]. Even though underlying mechanism that causes the poorer outcome of MIS in cervical cancer has yet to be identified, the collective findings have largely halted MIS for cervical cancer. Therefore, several societies announced position statement for MIS in cervical cancer. Korean Society of Gynecologic Oncology (KSGO), one of representative society in Korea, stated that all cervical cancer patients scheduled to undergo radical hysterectomy should be informed about the results of the LACC trial together with institutional data before choosing MIS. Furthermore, KSGO emphasized that establishment of optimal indication for MIS based on the tumor size and surgical methods to minimize tumor destruction or intraperitoneal spillage during colpotomy is required to ensure the oncologic safety of MIS in cervical cancer [4]. 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This phase III trial was designed for the definitive comparison of survival outcomes of radical hysterectomy in patients with early stage cervical cancer between minimally invasive surgery (MIS) and open procedure. This trial demonstrated that MIS is associated with lower rates of disease-free survival and overall survival than open procedure [2]. The findings of this LACC trial are consistent with those of a retrospective study based on the data from the Surveillance, Epidemiology, and End Results (SEER) program database of National Cancer Database (NCDB) for the year of 2000–2010 period [3]. Even though underlying mechanism that causes the poorer outcome of MIS in cervical cancer has yet to be identified, the collective findings have largely halted MIS for cervical cancer. Therefore, several societies announced position statement for MIS in cervical cancer. 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引用次数: 1

摘要

这是一篇在知识共享署名非商业许可(http://creativecommons.org/ licenses/by-nc/4.0)的条款下发布的开放获取文章,该许可允许在任何媒介上不受限制的非商业使用、分发和复制,前提是正确引用原始作品。在过去的几十年里,机器人辅助腹腔镜成为传统腹腔镜的一个进步,通过三维视图的可视化、更好的人体工程学、无震颤和更短的学习曲线等主要优势,可以在许多外科领域进行更复杂的手术。尽管缺乏大规模妇科随机对照试验的证据,但妇科机器人辅助腹腔镜手术已呈指数级增长,并已逐步成为妇科各领域的标准手术[1]。最近,美国食品和药物管理局警告不要在癌症手术中使用机器人手术,在第三期腹腔镜宫颈癌手术(LACC)试验后,指出“与传统手术相比,对患者的生存益处尚未确定”。这项III期试验旨在明确比较微创手术(MIS)和开放手术对早期宫颈癌患者根治性子宫切除术的生存结果。该试验表明,与开放式手术相比,MIS的无病生存率和总生存率较低[2]。这项LACC试验的结果与一项基于美国国家癌症数据库(NCDB)监测、流行病学和最终结果(SEER)项目数据库2000-2010年数据的回顾性研究结果一致[3]。尽管导致MIS在宫颈癌中预后较差的潜在机制尚未确定,但总的发现在很大程度上阻止了MIS在宫颈癌中的应用。因此,几个学会宣布了MIS在宫颈癌中的立场声明。韩国妇科肿瘤学会(Korean Society of Gynecologic Oncology, KSGO)是国内具有代表性的学会之一,该学会表示,所有计划行根治性子宫切除术的宫颈癌患者在选择MIS之前,应了解LACC试验的结果和机构数据。此外,KSGO强调,需要根据肿瘤大小和手术方法建立MIS的最佳适应证,以尽量减少阴道切开术中肿瘤破坏或腹腔内溢出,以确保MIS在宫颈癌中的肿瘤安全性[4]。另一方面,最近的一项系统综述显示,对于子宫内膜癌患者,机器人子宫切除术可能是比开放或腹腔镜子宫切除术更安全、更好的选择[5]。另一项荟萃分析对机器人子宫切除术与腹腔镜子宫切除术进行了比较,得出机器人子宫切除术在手术时间、出血量、总并发症发生率和转剖腹手术发生率方面无显著差异[6]。然而,不幸的是,关于肿瘤预后的数据非常有限。机器人手术;进入公共场所的时代
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Robotic surgery; into the era of common place
This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/ licenses/by-nc/4.0) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited. Since the past few decades, robot-assisted laparoscopy becomes an advancement of traditional laparoscopy and allows more complex procedures in many fields of surgery through main advantages including improved visualization by three-dimensional view, better ergonomics, no tremor, and shorter learning curves. Although the evidence from large-scaled randomized controlled trials in gynecology are lacking, gynecologic robot-assisted laparoscopy has shown exponential growth and has been progressively implemented as the standard procedure in various gynecologic field [1]. Recently, the US Food and Drug Administration cautioned against the use of robotic surgery in cancer operations, stating that “survival benefits to patients when compared to traditional surgery have not been established” after phase III Laparoscopic Approach to Cervical Cancer (LACC) trial. This phase III trial was designed for the definitive comparison of survival outcomes of radical hysterectomy in patients with early stage cervical cancer between minimally invasive surgery (MIS) and open procedure. This trial demonstrated that MIS is associated with lower rates of disease-free survival and overall survival than open procedure [2]. The findings of this LACC trial are consistent with those of a retrospective study based on the data from the Surveillance, Epidemiology, and End Results (SEER) program database of National Cancer Database (NCDB) for the year of 2000–2010 period [3]. Even though underlying mechanism that causes the poorer outcome of MIS in cervical cancer has yet to be identified, the collective findings have largely halted MIS for cervical cancer. Therefore, several societies announced position statement for MIS in cervical cancer. Korean Society of Gynecologic Oncology (KSGO), one of representative society in Korea, stated that all cervical cancer patients scheduled to undergo radical hysterectomy should be informed about the results of the LACC trial together with institutional data before choosing MIS. Furthermore, KSGO emphasized that establishment of optimal indication for MIS based on the tumor size and surgical methods to minimize tumor destruction or intraperitoneal spillage during colpotomy is required to ensure the oncologic safety of MIS in cervical cancer [4]. On the other hand, a recent systematic review showed that robotic hysterectomy may be a generally safer and better option than open or laparoscopic hysterectomy for patients with endometrial cancer [5]. Another meta-analysis compared robotic and laparoscopic hysterectomy concluded that there was no significant difference in the duration of surgery and the blood loss, the total complication rate and conversions to laparotomy were less in the robotic hysterectomy [6]. Unfortunately, however, very limited data are available regarding oncologic outcomes. One retrospecRobotic surgery; into the era of common place
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