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%; = 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.

中文翻译：

---

机器人辅助完全体内尿流改道根治性膀胱切除术与开放根治性膀胱切除术：随机对照试验的 3 年结果

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) 涉及体外尿流改道 (UD) 方法，削弱了完全机器人手术的潜在益处。我们的目标是比较 ORC 与 RARC 与完全体内 UD (iUD) 的随机对照试验的 3 年结果。患有cT2-4 N0 M0或卡介苗失败的高级别非肌层浸润性尿路上皮癌的患者被纳入研究，这些患者是RC候选者，没有机器人手术的绝对禁忌症。使用基于体重指数、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。主要终点是调查 RARC 联合 iUD 在输血率降低 50% 方面的优越性。次要结局包括遵守术后早期康复方案、围手术期和术后结局、再入院和并发症率、成本分析以及功能、肿瘤和健康相关的生活质量结局。总共有 116 名患者入组。主要终点得到确认，因为 RARC 队列的总体围手术期输血率显着降低，绝对风险降低了 19%（95% 置信区间 2–36%；= 0.046）。两组之间的围手术期和术后并发症以及 3 年肿瘤学结果没有差异。尽管 ORC 在定量分析夜间护垫使用方面具有优势，但白天和夜间失禁恢复的概率没有差异。 RARC 队列中的身体形象明显更好。成本分析证实 RARC 是一种更昂贵的外科手术。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 的微创性质反映在该队列中更好的身体形象感知上。各组之间白天和夜间失禁恢复的概率相当。成本较高仍然是机器人手术的一个缺点。该随机对照试验表明，与 ORC 相比，输血率降低了 50%。我们确认了 RARC 与 i-UD 的安全性和可行性，其围手术期和术后并发症发生率以及 3 年肿瘤学结果与 ORC 相当。接受 RARC-iUD 或 ORC 的患者术后尿失禁恢复的可能性相当。