Quality‐of‐life outcomes of the ROBOtic‐assisted versus Conventional Open Partial nephrectomy (ROBOCOP) II trial

Abstract

ObjectivesTo comprehensively compare quality‐of‐life (QoL) outcomes between open partial nephrectomy (OPN) and robot‐assisted PN (RAPN) from the randomised ROBOtic‐assisted versus Conventional Open Partial nephrectomy (ROBOCOP) II trial, as QoL data comparing OPN and RAPN are virtually non‐existent, especially not from randomised controlled trials (RCTs).Patients and MethodsThe ROBOCOP II was a single‐centre, open‐label RCT between OPN and RAPN. The pre‐planned analyses of QoL outcomes are presented. Data were analysed descriptively in a modified intention‐to‐treat population.ResultsA total of 50 patients underwent surgery. At postoperative Day 90 (POD90), there was no significant difference for the Kidney Disease Quality of Life‐Short Form questionnaire score (mean [sd] OPN 72 [20] vs RAPN 76 [15], P = 0.850), while there were advantages for RAPN in the subdomains of ‘Pain’ (P = 0.006) and ‘Physical functioning’ (P = 0.011) immediately after surgery. For the European Organisation for Research and Treatment of Cancer quality of life questionnaire 30‐item core there were overall advantages directly after surgery (mean [sd] score OPN 63 [20] vs RAPN 75 [17], P = 0.031), as well as for the subdomains ‘Fatigue’ (P = 0.026), ‘Pain’ (P = 0.002) and ‘Constipation’ (P = 0.045) but no differences at POD90. There were no differences for the EuroQoL five Dimensions five Levels questionnaire at POD90 (mean [sd] score OPN 70 [22] vs RAPN 72 [17], P = 1.0) or at any other time point. Finally, no significant differences were found for the overall Convalescence and Recovery Evaluation questionnaire score at POD90 (mean [sd] OPN 84 [13] vs RAPN 86 [10], P = 0.818) but less pain in the RAPN group (P = 0.017) directly after surgery.ConclusionsPain and physical functioning as subdomains of QoL are improved after RAPN compared to OPN in the early postoperative course, while there are no differences anymore after 3 months.