Department of Urology, IRCCS Regina Elena National Cancer Institute, Rome, Italy.
Department of Urology, IRCCS Regina Elena National Cancer Institute, Rome, Italy.
Eur Urol. 2024 May;85(5):422-430. doi: 10.1016/j.eururo.2024.01.018. Epub 2024 Feb 8.
Randomised controlled trials (RCTs) comparing open radical cystectomy (ORC) and robot-assisted RC (RARC) have involved an extracorporeal approach for urinary diversion (UD), undermining the potential benefits of a totally robotic procedure. Our objective was to compare 3-yr outcomes from a RCT comparing ORC to RARC with totally intracorporeal UD (iUD).
Patients with cT2-4 N0 M0 or bacillus Calmette-Guérin-failed high-grade non-muscle-invasive urothelial carcinoma who were candidates for RC without absolute contraindications to robotic surgery were included. A covariate adaptive randomisation process based on body mass index, American Society of Anesthesiologists score, preoperative haemoglobin, type of UD, neoadjuvant chemotherapy, and cT stage was used. The primary endpoint was to investigate the superiority of RARC with iUD in terms of a 50% reduction in transfusion rate. Secondary outcomes included adherence to an early recovery after surgery protocol, perioperative and postoperative outcomes, readmission and complication rates, a cost analysis, and functional, oncological, and health-related quality-of-life outcomes.
Overall, 116 patients were enrolled. The primary endpoint was confirmed, as the overall perioperative transfusion rate was significantly lower in the RARC cohort, with an absolute risk reduction of 19% (95% confidence interval 2-36%; p = 0.046). No differences in perioperative and postoperative complications and 3-yr oncological outcomes were observed between the groups. Despite the superiority of ORC on quantitative analysis of night-time pad use, there were no differences in the probabilities of recovery of daytime and night-time continence. Body image was significantly better in the RARC cohort. Cost analysis confirmed that RARC is a more expensive surgical procedure.
Our findings support RARC with iUD as a safe surgical option; the transfusion rate was reduced by 50% and the complication rates and 3-yr oncological outcomes were comparable to those with ORC. The minimally invasive nature of RARC was reflected in better body image perception in this cohort. The probabilities of daytime and night-time continence recovery were comparable between the groups. Higher costs remain a drawback of robotic surgery.
This RCT demonstrated a 50% transfusions rate's reduction compared to ORC. We confirmed safety and feasibility of RARC with i-UD providing comparable peri- and postoperative complication rates, as well as, 3yr oncologic outcomes to those of ORC. Patients receiving either RARC-iUD or ORC had comparable probabilities of urinary continence recovery after surgery.
比较开放根治性膀胱切除术（ORC）和机器人辅助 RC（RARC）的随机对照试验（RCT）均采用了体外尿路转流（UD）方法，这削弱了完全机器人手术的潜在益处。我们的目的是比较一项 RCT 的 3 年结果，该 RCT 比较了 ORC 与完全腔内 UD（iUD）的 RARC。
纳入了符合以下条件的 cT2-4 N0 M0 或卡介苗失败的高级别非肌肉浸润性尿路上皮癌患者，这些患者适合进行 RC 且无机器人手术的绝对禁忌证。采用基于体重指数、美国麻醉医师协会评分、术前血红蛋白、UD 类型、新辅助化疗和 cT 分期的协变量自适应随机化过程。主要终点是研究 RARC 联合 iUD 在降低输血率 50%方面的优势。次要结局包括术后早期恢复协议的依从性、围手术期和术后结局、再入院和并发症发生率、成本分析以及功能、肿瘤学和健康相关生活质量结局。
共有 116 名患者入组。主要终点得到确认，因为 RARC 组的围手术期总输血率显著降低，绝对风险降低 19%（95%置信区间 2-36%；p=0.046）。两组之间的围手术期和术后并发症以及 3 年肿瘤学结果无差异。尽管 ORC 在夜间垫使用的定量分析中具有优势，但日间和夜间控尿的恢复概率无差异。RARC 组的身体形象明显更好。成本分析证实 RARC 是一种更昂贵的手术。
我们的研究结果支持 RARC 联合 iUD 作为一种安全的手术选择；输血率降低了 50%，并发症发生率和 3 年肿瘤学结果与 ORC 相当。RARC 的微创性反映在该队列中更好的身体形象感知。两组日间和夜间控尿恢复的概率无差异。高成本仍然是机器人手术的一个缺点。
与 ORC 相比，本 RCT 显示输血率降低了 50%。我们证实了 RARC 联合 i-UD 的安全性和可行性，其围手术期和术后并发症发生率与 ORC 相当，3 年肿瘤学结果也相似。接受 RARC-iUD 或 ORC 的患者术后尿控恢复的概率无差异。
