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Fewer complications with robotic surgery in renal cancer

Presented by
Prof. Marc-Oliver Grimm, Universitätsklinikum Jena, Germany
Conference
EAU 2022
Trial
Phase 3, OpeRa
Doi
https://doi.org/10.55788/7e8ac5d6
Numerically lower complication rates were observed with robotic surgery versus open surgery in patients with intermediate or high complexity renal tumours. In addition, shorter hospital stays were reported in patients who underwent robotic surgery [1].

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.

 

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