Grimm M-O, Bedke J, Nyarangi-Dix J, Khoder W, Foller S, Sommerfeld H-J, Giessing M, Heck M, Meißner W, Slee A, Leucht K, von Rundstedt F, Theil G, Buse S, Siemer S, Albers P, Gratzke C, Hohenfellner M, Stenzl A
Department of Urology, Jena University Hospital, Friedrich-Schiller University, Jena, Germany; Comprehensive Cancer Center Germany (CCCG), Jena, Germany.
Department of Urology, Tübingen University Hospital, Tübingen, Germany.
Ann Oncol. 2025 Aug;36(8):988-998. doi: 10.1016/j.annonc.2025.04.005. Epub 2025 Apr 16.
The prospective, randomised, open-label, multicentre OpeRa trial (NCT03849820) aimed to determine whether robotic-assisted partial nephrectomy (RAPN) is superior to open partial nephrectomy (OPN) in reducing 30-day post-operative complications during the treatment of intermediate/high-complexity renal tumours.
Eligible patients aged ≥18 years had a renal tumour suitable for OPN or RAPN, a RENAL score ≥7, and an estimated glomerular filtration rate ≥50 ml/min/1.73 m. Patients were randomised from 15 March 2019 to 23 November 2021 in 12 German hospitals and assigned (1 : 1) to undergo RAPN or OPN. Primary endpoint was the 30-day post-operative complication rate [Clavien-Dindo (CD) I-V] in the modified intention-to-treat population. We aimed to recruit 606 patients to detect ≥10% reduction in the primary endpoint for RAPN versus OPN.
A total of 240 patients were randomised to RAPN (n = 123) or OPN (n = 117). Enrolment was stopped prematurely due to slow recruitment. After patient withdrawal post-randomisation, 117 patients underwent RAPN and 90 OPN. The primary endpoint was assessable in 112 and 89 patients, respectively. The 30-day complication rate did not differ between groups: RAPN 41/112 (37%) versus OPN 41/89 (46%) (one-sided: P = 0.088). The difference of -9.5% (95% confidence interval -23.1% to 4.2%) numerically favoured RAPN. The most frequent high-grade complications (CD III-IV) to post-operative day 30 (POD30) were urine leakage [RAPN 4/112 (4%) versus OPN 2/89 (2%)] and post-operative bleeding [2/117 (2%) versus 1/89 (1%)]. Compared with OPN, RAPN patients had longer operative and warm ischaemia times, shorter hospital stay, and reported better recovery, less opioid use, less pain, and improved quality of life (QoL) up to POD30.
There was no statistically significant difference in the 30-day complication rate between RAPN and OPN in this underpowered trial. Few high-grade complications occurred over the whole cohort with intermediate/high-complexity tumours. Despite less intense pain management, patients undergoing RAPN reported less pain and better QoL up to POD30.
前瞻性、随机、开放标签、多中心OpeRa试验（NCT03849820）旨在确定在治疗中/高复杂性肾肿瘤时，机器人辅助部分肾切除术（RAPN）在降低术后30天并发症方面是否优于开放性部分肾切除术（OPN）。
年龄≥18岁、患有适合OPN或RAPN的肾肿瘤、RENAL评分≥7且估计肾小球滤过率≥50 ml/min/1.73 m²的患者符合条件。2019年3月15日至2021年11月23日期间，12家德国医院的患者被随机分组（1:1），接受RAPN或OPN治疗。主要终点是改良意向性治疗人群中的术后30天并发症发生率[Clavien-Dindo（CD）I-V级]。我们旨在招募606名患者，以检测RAPN与OPN相比主要终点降低≥10%。
共有240名患者被随机分配至RAPN组（n = 123）或OPN组（n = 117）。由于入组缓慢，研究提前终止。随机分组后有患者退出，117例患者接受了RAPN治疗，90例接受了OPN治疗。分别有112例和89例患者的主要终点可评估。两组间30天并发症发生率无差异：RAPN组41/112（37%），OPN组41/89（46%）（单侧：P = 0.088）。-9.5%的差异（95%置信区间为-23.1%至4.2%）在数值上有利于RAPN组。至术后第30天（POD30）最常见的高级别并发症（CD III-IV级）为尿漏[RAPN组4/112（4%），OPN组2/89（2%）]和术后出血[2/117（2%），1/89（1%）]。与OPN相比，RAPN组患者手术时间和热缺血时间更长，住院时间更短，且报告恢复更好、阿片类药物使用更少、疼痛更轻，至POD30时生活质量（QoL）改善。
在这项效能不足的试验中，RAPN与OPN的30天并发症发生率无统计学显著差异。在整个中/高复杂性肿瘤队列中，高级别并发症较少。尽管疼痛管理强度较低，但接受RAPN治疗的患者至POD30时疼痛更轻，QoL更好。
