Two-year Follow-up for Oncological, Functional, and Quality-of-Life Outcomes in the Randomized ROBOCOP II Trial of Robot-assisted Versus Conventional Open Partial Nephrectomy

Background and objective Robot-assisted partial nephrectomy (RAPN) is increasingly used to treat renal cell carcinoma (RCC), but randomized data comparing long-term outcomes to those after open partial nephrectomy (OPN) remain limited. Our aim was to compare oncological, renal function, and health-related quality of life (HRQOL) outcomes at 2 yr for patients who underwent RAPN versus OPN. Methods This single-center phase 2 randomized controlled trial included 50 patients with suspected localized RCC who were randomized 1:1 to RAPN or OPN. After 2-yr follow-up, we assessed overall survival (OS), recurrence-free survival, renal function, and HRQOL, including chronic postoperative pain and flank bulge. Analyses were conducted on an intention-to-treat basis. Key findings and limitations All but one patient completed oncological and renal follow-up, and 47 provided HRQOL data. At 2 yr, overall survival was 100%, with one lymph-node recurrence in the RAPN group. The adjusted mean estimated glomerular filtration rate did not differ between the groups (OPN 74.1 ml/min/1.73 m 2 , 95% confidence interval [CI] 69.7–78.5; RAPN 75.8 ml/min/1.73 m 2 , 95% CI 71.3–80.1; p = 0.59). HRQOL at 2 yr remained high, with no significant difference in changes from baseline between the two groups. Chronic postoperative pain at the operative site (44% vs 0%; p = 0.001) and flank bulge (32% vs 0%; p = 0.007) were significantly more common in the OPN group versus the RAPN group. Conclusions and clinical implications RAPN and OPN yielded excellent long-term outcomes. RAPN offers advantages in terms of postoperative morbidity without compromising renal function or QOL.