A Novel Robotic System for Single-port Urologic Surgery: First Clinical Investigation
A Novel Robotic System for Single-port Urologic Surgery: First Clinical Investigation
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DOI：
10.1016/j.eururo.2014.06.039
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发表时间：
2014-12-01
期刊：
影响因子：
23.4
通讯作者：
Villers, Arnauld
中科院分区：
文献类型：
--
作者：
Kaouk, Jihad H.;Haber, Georges-Pascal;Villers, Arnauld
背景：通过单个腹部切口进行腹腔镜手术的想法是为了加快术后恢复。目的：探讨一种新型机器人手术系统在泌尿外科单孔手术中的临床可行性和安全性。设计、环境和参与者：这是一项前瞻性机构审查委员会批准的创新、发展、探索、评估、长期研究（IDEAL）一期研究。入组后，患者于2010年7月接受了为期3周的主要泌尿外科机器人单孔手术。术后随访3年。干预：采用达芬奇SP手术系统进行不同类型的泌尿外科手术。该系统旨在提供与现有多端口达芬奇系统相同的核心临床功能，除了三个铰接内窥镜仪器和一个铰接内窥镜相机通过单个机器人端口插入患者体内。结果测量和统计分析：主要结果是手术的技术可行性（以转换率衡量）和手术的安全性（以围手术期并发症的发生率衡量）。次要终点包括评估其他关键手术围手术期结果以及中期功能和肿瘤结果。结果和局限性：共有19例患者入组研究。其中11例行根治性前列腺切除术；8名受试者接受了肾切除术（部分肾切除术4例，根治性肾切除术2例，单纯性肾切除术2例）。没有转换到其他手术入路。总体而言，根治性前列腺切除术组观察到2个主要的术后并发症（Clavien分级3b），肾切除术组无并发症。随访1年，1例根治性前列腺切除术患者出现生化复发，经补救性放射治疗成功。其中3例肾部分切除术的中位热缺血时间为38分钟。在3年的随访中，所有患者的肾功能都得到了保留；无肿瘤复发。研究的局限性包括样本量小和缺乏对照组。结论：我们描述了一种专门为单口泌尿外科手术设计的新型机器人平台的首次临床应用。主要泌尿外科手术均顺利完成，无转诊。有必要进一步评估以证实这些有希望的发现。患者总结：一种新型的专用机器人系统使外科医生能够通过一个小的腹部切口安全有效地执行各种主要的泌尿外科手术。(C) 2014欧洲泌尿外科协会。Elsevier B.V.版权所有。
Background: The idea of performing a laparoscopic procedure through a single abdominal incision was conceived with the aim of expediting postoperative recovery.Objective: To determine the clinical feasibility and safety of single-port urologic procedures by using a novel robotic surgical system.Design, setting, and participants: This was a prospective institutional review board-approved, Innovation, Development, Exploration, Assessment, Long-term Study (IDEAL) phase 1 study. After enrollment, patients underwent a major urologic robotic single-port procedure over a 3-wk period in July 2010. The patients were followed for 3 yr postoperatively.Intervention: Different types of urologic surgeries were performed using the da Vinci SP Surgical System. This system is intended to provide the same core clinical capabilities as the existing multiport da Vinci system, except that three articulating endoscopic instruments and an articulating endoscopic camera are inserted into the patient through a single robotic port.Outcome measurements and statistical analysis: The main outcomes were the technical feasibility of the procedures (as measured by the rate of conversions) and the safety of the procedures (as measured by the incidence of perioperative complications). Secondary end points consisted of evaluating other key surgical perioperative outcomes as well as midterm functional and oncologic outcomes.Results and limitations: A total of 19 patients were enrolled in the study. Eleven of them underwent radical prostatectomy; eight subjects underwent nephrectomy procedures (partial nephrectomy, four; radical nephrectomy, two; and simple nephrectomy, two). There were no conversions to alternative surgical approaches. Overall, two major (Clavien grade 3b) postoperative complications were observed in the radical prostatectomy group and none in the nephrectomy group. At 1-yr follow-up, one radical prostatectomy patient experienced biochemical recurrence, which was successfully treated with salvage radiation therapy. The median warm ischemia time for three of the partial nephrectomies was 38 min. At 3-yr follow-up all patients presented a preserved renal function; none had tumor recurrence. Study limitations include the small sample and the lack of a control group.Conclusions: We describe the first clinical application of a novel robotic platform specifically designed for single-port urologic surgery. Major urologic procedures were successfully completed without conversions. Further assessment is warranted to corroborate these promising findings.Patient summary: A novel purpose-built robotic system enables surgeons to perform safely and effectively a variety of major urologic procedures through a single small abdominal incision. (C) 2014 European Association of Urology. Published by Elsevier B.V. All rights reserved.