Hatakeyama Shingo, Yamamoto Hiroyuki, Kitamura Hiroshi, Kamoto Toshiyuki, Kikuchi Eiji
National Clinical Database Steering Committee of Japanese Urological Association, Tokyo, Japan.
Department of Urology, Hirosaki University Graduate School of Medicine, Hirosaki, Japan.
Cancer Med. 2025 Aug;14(15):e71109. doi: 10.1002/cam4.71109.
Radical cystectomy (RC) is a standard-of-care treatment for muscle-invasive bladder cancer (MIBC). However, there is a lack of data comparing the benefit of robot-assisted radical cystectomy (RARC) with laparoscopic radical cystectomy (LRC) or open radical cystectomy (ORC) in Japan. We aimed to explore the safety of RARC compared with that of LRC or ORC using the Japanese National Clinical Database (NCD).
This retrospective study reviewed the data of 17,549 patients with MIBC who underwent radical cystectomy between February 2019 and December 2022 in the Japanese NCD. We compared the postoperative complications within 30 days between the surgical procedures using the Clavien-Dindo classification. Multivariable logistic regression analysis was conducted for grade ≥ 3 postoperative complications.
Overall, 8308, 3101, and 6140 patients underwent RARC, LRC, and ORC, respectively. The rates of any grade and grade ≥ 3 postoperative complications within 30 days were significantly lower in the RARC group than in the ORC group. RARC had no significant difference in grade ≥ 3 postoperative complications in the ileal neobladder. Regarding any grade postoperative complications, RARC had a significantly lower rate of delirium, surgical site infection, sepsis, and gastrointestinal tract leakage than ORC. Multivariable logistic regression analysis revealed that the incidence of grade ≥ 3 postoperative complications was significantly lower in RARC (odds ratio, 0.83; 95% confidence interval, 0.72-0.95).
RARC had a lower complication rate compared with ORC. LRC had comparable outcomes to RARC. The findings of this study contribute to RARC as being the standard treatment for MIBC.
根治性膀胱切除术(RC)是肌层浸润性膀胱癌(MIBC)的标准治疗方法。然而,在日本,缺乏比较机器人辅助根治性膀胱切除术(RARC)与腹腔镜根治性膀胱切除术(LRC)或开放性根治性膀胱切除术(ORC)疗效的数据。我们旨在利用日本国家临床数据库(NCD)探讨RARC与LRC或ORC相比的安全性。
这项回顾性研究回顾了2019年2月至2022年12月在日本NCD接受根治性膀胱切除术的17549例MIBC患者的数据。我们使用Clavien-Dindo分类法比较了手术方式之间30天内的术后并发症。对≥3级术后并发症进行多变量逻辑回归分析。
总体而言,分别有8308例、3101例和6140例患者接受了RARC、LRC和ORC。RARC组30天内任何级别的术后并发症发生率和≥3级术后并发症发生率均显著低于ORC组。RARC在回肠新膀胱≥3级术后并发症方面无显著差异。关于任何级别的术后并发症,RARC的谵妄、手术部位感染、脓毒症和胃肠道漏发生率均显著低于ORC。多变量逻辑回归分析显示,RARC中≥3级术后并发症的发生率显著较低(优势比,0.83;95%置信区间,0.72-0.95)。
与ORC相比,RARC的并发症发生率较低。LRC的结果与RARC相当。本研究结果有助于将RARC作为MIBC的标准治疗方法。