Department of Urology, Rijnstate Hospital, Arnhem, The Netherlands.
Department of Urology, Rijnstate Hospital, Arnhem, The Netherlands; Department of Operating Rooms, Radboud Institute for Health Sciences, Radboud University Medical Center, Nijmegen, The Netherlands.
Eur Urol. 2021 May;79(5):609-618. doi: 10.1016/j.eururo.2020.12.023. Epub 2021 Jan 11.
Radical cystectomy with pelvic lymph node dissection (PLND) and urinary diversion in patients with bladder cancer is known for its high risk of complications. Although open radical cystectomy (ORC) is regarded as the standard treatment, robot-assisted radical cystectomy (RARC) is increasingly used in practice, despite the fact that high-quality evidence comparing the effectiveness of both techniques is lacking.
To study the effectiveness of RARC compared with that of ORC, in terms of 90 d complications (Clavien-Dindo), health-related quality of life (HRQOL), and clinical outcomes.
DESIGN, SETTING, AND PARTICIPANTS: A prospective comparative effectiveness study was conducted in 19 Dutch centres, expert in either ORC or RARC. Follow-up visits were scheduled at 30, 90, and 365 d.
Standard ORC or RARC with PLND, using a standardised perioperative protocol.
The primary outcome was any-grade complications after 90 d. Secondary outcomes included HRQOL, complications (minor, major, 30 d, and 365 d), and clinical outcomes. Differences were calculated as risk differences (RDs) between the groups with 95% confidence intervals (CIs), adjusted for potential baseline differences by means of propensity score-based inverse probability of treatment weighting.
Between March 2016 and November 2018, 348 patients were included (n = 168 for ORC, n = 180 for RARC). At 90 d, any-grade complication rates were 63% for ORC and 56% for RARC (RD -6.4%, 95% CI -17 to 4.5). Major complication rates were 15% for ORC and 16% for RARC (RD 0.9%, 95% CI -7.0 to 8.8). Total minor complication rates were 57% for ORC and 49% for RARC (RD -7.6%, 95% CI -19 to 3.6). Analyses showed no statistically significant differences in HRQOL between ORC and RARC. Some differences were found in the secondary outcomes in favour of either RARC or ORC. The major drawback inherent to the design comprises residual confounding.
This multicentre comparative effectiveness study showed no statistically significant differences between ORC and RARC in terms of complications and HRQOL.
This multicentre study did not show differences in overall complication rates, health-related quality of life, mortality, and clinical and oncological outcomes between open and robot-assisted radical cystectomy in bladder cancer patients.
膀胱癌患者行根治性膀胱切除术（RC）加盆腔淋巴结清扫术（PLND）和尿流改道术，其并发症风险高。虽然开放性 RC（ORC）被认为是标准治疗方法，但机器人辅助 RC（RARC）在实践中越来越多地被应用，尽管缺乏比较两种技术有效性的高质量证据。
研究 RARC 与 ORC 在 90 天并发症（Clavien-Dindo 分级）、健康相关生活质量（HRQOL）和临床结局方面的有效性。
设计、地点和参与者：这是一项在 19 家荷兰中心进行的前瞻性比较有效性研究，这些中心均擅长 ORC 或 RARC。随访时间分别为 30、90 和 365 天。
PLND 行标准 ORC 或 RARC，采用标准化围手术期方案。
主要结局为 90 天后任何级别的并发症。次要结局包括 HRQOL、并发症（轻度、重度、30 天和 365 天）和临床结局。差异计算为两组之间的风险差异（RD），置信区间（CI）为 95%，通过基于倾向评分的逆概率治疗加权调整潜在基线差异。
2016 年 3 月至 2018 年 11 月，共纳入 348 例患者（ORC 组 168 例，RARC 组 180 例）。90 天时，ORC 的任何级别并发症发生率为 63%，RARC 为 56%（RD-6.4%，95%CI-17%至 4.5%）。ORC 的主要并发症发生率为 15%，RARC 为 16%（RD 0.9%，95%CI-7.0%至 8.8%）。ORC 的总轻度并发症发生率为 57%，RARC 为 49%（RD-7.6%，95%CI-19%至 3.6%）。分析显示，ORC 和 RARC 之间在 HRQOL 方面无统计学显著差异。在某些次要结局中，RARC 或 ORC 存在优势。设计固有的主要缺陷是存在残余混杂。
这项多中心比较有效性研究显示，在并发症和 HRQOL 方面，ORC 和 RARC 之间无统计学显著差异。
这项多中心研究未显示在膀胱癌患者中，开放性和机器人辅助根治性膀胱切除术在总体并发症发生率、健康相关生活质量、死亡率以及临床和肿瘤学结局方面存在差异。
