The phase 3 OpeRa trial (NCT03849820) was designed to show the superiority of robot-assisted partial nephrectomy (RAPN) to open partial nephrectomy (OPN) in patients with intermediate or high complexity kidney tumours. Prof. Marc-Oliver Grimm (Universitätsklinikum Jena, Germany) presented the results. Due to slow enrolment, only 240 patients instead of the indicated 606 patients were randomised 1:1 to RAPN or OPN. In total, 95% of patients in the RAPN group and 77% of patients in the OPN group received the anticipated treatment. The 30-day post-operative complication rate was the primary endpoint of the trial.
A trend towards a reduced 30-day complication rate was observed in favour of the RAPN arm (36.6% vs 46.1%; P=0.175). This effect was mostly driven by a decreased rate of grade 1 (OPN 19.1% vs RAPN 11.6%) and grade 2 (19.1% vs 13.4%) adverse events (AEs) in the RAPN arm. The corresponding grade 3-a, grade 3-b, and grade 4-a AE rates were comparable between the 2 arms, with 3.4%, 3.4%, and 1.1% in the OPN arm and 5.4%, 4.5%, and 1.8% in the RAPN arm, respectively. A substantial difference between AEs ‘possibly or definitely’ related to treatment was observed to the benefit of those who received RAPN (37.1% vs 23.2%; P=0.032). Also, the number of post-operative hospital days to discharge was lower in patients who received RAPN (7 vs 6; P<0.001). In contrast, the median operating time was significantly longer in the RAPN arm (167 vs 122 minutes; P<0.001).
Prof. Grimm concluded that, although underpowered, the trial showed a clear trend for fewer complications with robotic surgery compared with open surgery in patients with intermediate or high complexity renal tumours. Analyses of postoperative pain medication, patient-reported outcomes, and quality of life are ongoing.
1. Grimm M-O, et al. Complications with open versus robotic-assisted partial nephrectomy (OpeRa) in patients with intermediate/high-complexity kidney tumours. Game-changing session 1, EAU 2022, 01–04 July.