Prospective Randomized Controlled Trial of Robotic versus Open Radical Cystectomy for Bladder Cancer: Perioperative and Pathologic Results
Prospective Randomized Controlled Trial of Robotic versus Open Radical Cystectomy for Bladder Cancer: Perioperative and Pathologic Results
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DOI：
10.1016/j.eururo.2009.10.024
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发表时间：
2010-02-01
期刊：
影响因子：
23.4
通讯作者：
Pruthi, Raj S.
中科院分区：
文献类型：
--
作者：
Nix, Jeff;Smith, Angela;Pruthi, Raj S.
背景：近年来，外科医生已经开始报道一系列根治性膀胱切除术的微创方法，包括机器人辅助技术，证明了这种手术的可行性，具有出血少、肠功能恢复和出院速度快的潜力。尽管有这些经验和观察，但在这一点上，缺乏关于机器人膀胱切除术益处的高水平临床证据，目前的经验代表了病例系列，充其量只能与历史对照进行有限的比较。目的：我们报告了一项关于开放和机器人辅助的腹腔镜根治性膀胱切除术的前瞻性随机试验的结果，比较了围手术期结局、并发症和短期麻醉药物的使用。设计、背景和参与者：一项前瞻性随机单中心非劣势研究，比较了开放和机器人方法在膀胱尿路上皮癌根治性膀胱切除术患者中的应用。在接受手术的41名患者中，21名随机接受机器人手术，20名接受开放手术。干预：根治性膀胱切除、双侧盆腔淋巴清扫和尿流改道，采用开放手术入路或机器人辅助的腹腔镜技术。测量：主要终点是淋巴结(LN)产量，非劣质边缘为4个LN。次要终点包括人口学特征、围手术期结果、病理结果和短期麻醉药物使用情况。结果与局限性：单因素分析显示，两组患者在年龄、性别、体重指数、美国麻醉医师学会分类、阿司匹林抗凝方案、临床分期或改道类型等方面均无显著差异。在手术室时间、估计失血量、排气时间、排便时间和住院患者使用硫酸吗啡等效物方面有显著差异。在总体并发症发生率或住院时间方面没有显著差异。在手术病理上，机器人组有14例pt2病或以上，3例pt3/t4病，4例结节阳性。在开放组中，8例pt2病或更高；5例pt3/t4病；7例结节阳性疾病。机器人组平均摘除19枚LN，开放组为18枚。潜在的研究局限性包括有限的临床和肿瘤学随访，以及研究相对较小和单一机构的性质。结论：我们展示了一项以LN产量为主要终点的前瞻性随机对照非劣势研究的结果，证明了机器人方法不逊于开放方法。在围手术期的几个参数上，机器人手术入路也优于开放手术入路。(C)2009年欧洲泌尿外科协会。爱思唯尔出版公司版权所有。
Background: In recent years, surgeons have begun to report case series of minimally invasive approaches to radical cystectomy, including robotic-assisted techniques demonstrating the surgical feasibility of this procedure with the potential of lower blood loss and more rapid return of bowel function and hospital discharge. Despite these experiences and observations, at this point high levels of clinical evidence with regard to the benefits of robotic cystectomy are absent, and the current experiences represent case series with limited comparisons to historical controls at best.Objective: We report our results on a prospective randomized trial of open versus robotic-assisted laparoscopic radical cystectomy with regard to perioperative outcomes, complications, and short-term narcotic usage.Design, setting, and participants: A prospective randomized single-center noninferiority study comparing open versus robotic approaches to cystectomy in patients who are candidates for radical cystectomy for urothelial carcinoma of the bladder. Of the 41 patients who underwent surgery, 21 were randomized to the robotic approach and 20 to the open technique.Intervention: Radical cystectomy, bilateral pelvic lymphadenectomy, and urinary diversion by either an open approach or by a robotic-assisted laparoscopic technique.Measurements: The primary end point was lymphnode (LN) yield with a noninferiority margin of four LNs. Secondary end points included demographic characteristics, perioperative outcomes, pathologic results, and short-term narcotic use.Results and limitations: On univariate analysis, no significant differences were found between the two groups with regard to age, sex, body mass index, American Society of Anesthesiologists classification, anticoagulation regimen of aspirin, clinical stage, or diversion type. Significant differences were noted in operating room time, estimated blood loss, time to flatus, time to bowel movement, and use of inpatient morphine sulfate equivalents. There was no significant difference in regard to overall complication rate or hospital stay. On surgical pathology, in the robotic group 14 patients had pT2 disease or higher; 3 patients had pT3/T4 disease; and 4 patients had node-positive disease. In the open group, eight patients had pT2 disease or higher; five patients had pT3/T4 disease; and seven patients had node-positive disease. The mean number of LNs removed was 19 in the robotic group versus18 in the open group. Potential study limitations include the limited clinical and oncologic follow-up and the relatively small and single-institution nature of the study.Conclusions: We present the results of a prospective randomized controlled noninferiority study with a primary end point of LN yield, demonstrating the robotic approach to be noninferior to the open approach. The robotic approach also compares favorably with the open approach in several perioperative parameters. (C) 2009 European Association of Urology. Published by Elsevier B. V. All rights reserved.