Open versus robotic-assisted partial nephrectomy in patients with intermediate/high-complexity kidney tumours: final results of the randomised, controlled, open-label, multicentre trial OpeRa.

patients_and_methods

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 m2.

符合条件的患者年龄≥18岁，具有适合OPN或RAPN的肾肿瘤，RENAL评分≥7，以及估算的肾小球滤过率≥50 ml/min/1.73 m2。

Patients were randomised from 15 March 2019 to 23 November 2021 in 12 German hospitals and assigned (1 : 1) to undergo RAPN or OPN.

患者从2019年3月15日至2021年11月23日在德国的12家医院进行随机分组，并按1:1的比例被分配接受机器人辅助腹腔镜肾部分切除术(RAPN)或开放性肾部分切除术(OPN)。

Primary endpoint was the 30-day post-operative complication rate [Clavien-Dindo (CD) I-V] in the modified intention-to-treatpopulation.

主要终点是改良意向治疗人群中30天术后并发症发生率[Clavien-Dindo (CD) I-V级]。

We aimed to recruit 606 patients to detect ≥10% reduction in the primary endpoint for RAPN versus OPN.

我们的目标是招募606名患者，以检测RAPN与OPN相比主要终点指标减少≥10%。

Results

A total of 240 patients were randomised to RAPN (n = 123) or OPN (n = 117).

共有240名患者被随机分配至RAPN组（n = 123）或OPN组（n = 117）。

Enrolment was stopped prematurely due to slow recruitment.

由于招募缓慢，入组工作提前终止。

After patient withdrawal post-randomisation, 117 patients underwent RAPN and 90 OPN.

在随机化后患者退出的情况下，有117名患者接受了机器人辅助腹腔镜肾部分切除术（RAPN），90名患者接受了开放性肾部分切除术（OPN）。

The primary endpoint was assessable in 112 and 89 patients, respectively.

主要终点在分别112名和89名患者中可评估。

The 30-day complication rate did not differ between groups: RAPN 41/112 (37%) versus OPN 41/89 (46%) (one-sided: P = 0.088).

两组30天并发症发生率无差异：机器人辅助腹腔镜肾部分切除术（RAPN）组41/112（37%）与开放性肾部分切除术（OPN）组41/89（46%）（单侧检验：P = 0.088）。

The difference of -9.5% (95% confidence interval-23.1% to 4.2%) numerically favoured RAPN.

数值上，-9.5%（95%置信区间-23.1%至4.2%）有利于机器人辅助腹腔镜肾部分切除术（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%)].

术后30天（POD30）最常见的高级别并发症（CD III-IV级）是尿液泄漏[RAPN 4/112（4%）对比开放性肾部分切除术（OPN）2/89（2%）]和术后出血[2/117（2%）对比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.

与OPN相比，RAPN患者的手术时间和热缺血时间更长，住院时间更短，并报告了更好的恢复情况、较少的阿片类药物使用、较少的疼痛以及直至术后30天的生活质量（QoL）的改善。

Conclusions

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.

在这项样本量不足的试验中，RAPN和OPN之间30天并发症发生率没有统计学上的显著差异。整个队列中，中高复杂性肿瘤患者出现的高级别并发症较少。

Despite less intense pain management, patients undergoing RAPN reported less pain and better QoL up to POD30.

尽管疼痛管理强度较低，但接受机器人辅助部分肾切除术（RAPN）的患者在术后30天内报告的疼痛较少，生活质量（QoL）更好。