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
Mené en Allemagne sur 240 patients atteints d'une tumeur rénale de complexité intermédiaire ou élevée, cet essai randomisé multicentrique compare l'efficacité, du point de vue du taux de complications postopératoires à 30 jours, de 2 types de néphrectomie partielle, l'une assistée par robot et l'autre par voie ouverte
Background: 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 postoperative complications during the treatment of intermediate/high-complexity renal tumours.
Patients and methods: Eligible patients aged ≥18 years had a renal tumour suitable for OPN or RAPN, a RENAL score ≥7, and an eGFR ≥50ml/min/1.73m2. Patients were randomised from 15-Mar-2019 to 23-Nov-2021 in 12 German hospitals and assigned (1:1) to undergo RAPN or OPN. Primary endpoint was the 30-day postoperative complication rate (Clavien-Dindo I-V) in the modified intention-to-treat (mITT) population. We aimed to recruit 606 patients to detect ≥10% reduction in the primary endpoint for RAPN vs. OPN.
Results: 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%) vs. OPN 41/89 (46%) (one-sided: P=0.088). The difference of -9.5% (95% CI -23.1–4.2) numerically favoured RAPN. The most frequent high-grade complications (Clavien-Dindo III-IV) to postoperative day 30 (POD30) were urine leakage (RAPN 4/112 [4%] vs. OPN 2/89 [2%]) and postoperative bleeding (2/117 [2%] vs. 1/89 [1%]). Compared to 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 up to POD30.
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. Despite less intense pain management, patients undergoing RAPN reported less pain and better quality of life up to POD30.
Annals of Oncology , résumé 2025