Comparing Open Radical Cystectomy and Robot-assisted Laparoscopic Radical Cystectomy: A Randomized Clinical Trial.
Comparing Open Radical Cystectomy and Robot-assisted Laparoscopic Radical Cystectomy: A Randomized Clinical Trial.
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DOI：
10.1016/j.eururo.2014.11.043
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发表时间：
2015-06
期刊：
影响因子：
23.4
通讯作者：
Laudone, Vincent P.
中科院分区：
文献类型：
--
作者：
Bochner, Bernard H.;Dalbagni, Guido;Sjoberg, Daniel D.;Silberstein, Jonathan;Paz, Gal E. Keren;Donat, S. Machele;Coleman, Jonathan A.;Mathew, Sheila;Vickers, Andrew;Schnorr, Geoffrey C.;Feuerstein, Michael A.;Rapkin, Bruce;Parra, Raul O.;Herr, Harry W.;Laudone, Vincent P.
关键词：
膀胱癌（BCa）患者的开放性根治性膀胱切除术（ORC）和尿流改道与显著的围手术期并发症风险相关。比较机器人辅助根治性膀胱切除术（RARC）和ORC技术的围手术期并发症。2010年至2013年期间，在计划通过根治性膀胱癌（RC）、盆腔淋巴结清扫术（PLND）和尿流改道进行确定性治疗的BCa患者中进行了一项前瞻性随机对照试验。患者被随机分配至ORC/PLND或RARC/PLND，均采用开放性尿流改道。术后随访90 d。标准ORC或RARC伴PLND;所有尿流改道均通过开放性方法进行。主要结局为改良Clavien系统定义的总体90天2-5级并发症。次要结局包括比较高级并发症、估计失血量、手术时间、病理结局、3个月和6个月患者报告的生活质量（QOL）结局以及手术室和住院总费用。采用卡方检验评估二元结局的差异，采用随机分组作为协变量的协方差分析评估连续结局的差异，对于QOL终点，采用基线评分。该试验入组了124例患者，其中118例随机分组并接受了RC/PLND。60例随机分配至RARC，58例随机分配至ORC。在90天时，分别在62%和66%的RARC和ORC患者中观察到2-5级并发症（差异的95%置信区间为-21%至13%; p = 0.7）。在我们强制的中期分析中，2-5级并发症的发生率相似，符合无效标准;因此，试验提前结束。与ORC组相比，RARC组的平均术中失血量较低（p = 0.027），但手术时间显著较长（p < 0.001）。病理变量，包括积极的手术切缘和淋巴结产量相似。两组的平均住院时间均为8天（标准差分别为3天和5天; p = 0.5）。两组之间的3个月和6个月QOL结局相似。成本分析表明，与RARC相比，ORC具有优势。一个局限性是在一个单一的高容量，转诊中心的设置，我们的研究结果可能无法推广到所有的设置。该试验未能确定机器人辅助技术在接受RC/PLND和尿流改道的患者中优于标准开放手术的巨大优势。无论手术技术如何，观察到相似的90天并发症发生率、住院时间、病理结局以及3个月和6个月QOL结局。在118例接受根治性膀胱切除术、盆腔淋巴结清扫术和尿流改道术的膀胱癌患者中，一半随机接受开放手术，一半接受机器人辅助腹腔镜手术。我们比较了开放组与机器人组术后90天内的并发症发生率，发现两组之间无显著差异。
Open radical cystectomy (ORC) and urinary diversion in patients with bladder cancer (BCa) are associated with significant perioperative complication risk. To compare perioperative complications between robot-assisted radical cystectomy (RARC) and ORC techniques. A prospective randomized controlled trial was conducted during 2010 and 2013 in BCa patients scheduled for definitive treatment by radical cystectomy (RC), pelvic lymph node dissection (PLND), and urinary diversion. Patients were randomized to ORC/PLND or RARC/PLND, both with open urinary diversion. Patients were followed for 90 d postoperatively. Standard ORC or RARC with PLND; all urinary diversions were performed via an open approach. Primary outcomes were overall 90-d grade 2–5 complications defined by a modified Clavien system. Secondary outcomes included comparison of high-grade complications, estimated blood loss, operative time, pathologic outcomes, 3- and 6-mo patient-reported quality-of-life (QOL) outcomes, and total operative room and inpatient costs. Differences in binary outcomes were assessed with the chi-square test, with differences in continuous outcomes assessed by analysis of covariance with randomization group as covariate and, for QOL end points, baseline score. The trial enrolled 124 patients, of whom 118 were randomized and underwent RC/PLND. Sixty were randomized to RARC and 58 to ORC. At 90 d, grade 2–5 complications were observed in 62% and 66% of RARC and ORC patients, respectively (95% confidence interval for difference, −21% to −13%; p = 0.7). The similar rates of grade 2–5 complications at our mandated interim analysis met futility criteria; thus, early closure of the trial occurred. The RARC group had lower mean intraoperative blood loss (p = 0.027) but significantly longer operative time than the ORC group (p < 0.001). Pathologic variables including positive surgical margins and lymph node yields were similar. Mean hospital stay was 8 d in both arms (standard deviation, 3 and 5 d, respectively; p = 0.5). Three- and 6-mo QOL outcomes were similar between arms. Cost analysis demonstrated an advantage to ORC compared with RARC. A limitation is the setting at a single high-volume, referral center; our findings may not be generalizable to all settings. This trial failed to identify a large advantage for robot-assisted techniques over standard open surgery for patients undergoing RC/PLND and urinary diversion. Similar 90-d complication rates, hospital stay, pathologic outcomes, and 3- and 6-mo QOL outcomes were observed regardless of surgical technique. Of 118 patients with bladder cancer who underwent radical cystectomy, pelvic lymph node dissection, and urinary diversion, half were randomized to open surgery and half to robot-assisted laparoscopic surgery. We compared the rate of complications within 90 d after surgery for the open group versus the robotic group and found no significant difference between the two groups.
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