Open versus robot‐assisted radical cystectomy: pentafecta and trifecta achievement comparison from a randomised controlled trial

Abstract

OBJECTIVES: To compare University of Southern California (USC) Institute of Urology pentafecta and trifecta achievement comparing open radical cystectomy (ORC) vs robot-assisted RC (RARC) with totally intracorporeal urinary diversion (iUD) from a randomised controlled trial (RCT). PATIENTS AND METHODS: Patients were eligible for randomisation if they had a diagnostic transurethral resection of bladder tumour with clinical T stage (cT)2-4, cN0, cM0, or recurrent high-grade non-muscle-invasive bladder cancer and no anaesthesia contraindications to robotic surgery. Patients were enrolled with a covariate adaptive randomisation process based on the following variables: body mass index, American Society of Anesthesiologists score, preoperative haemoglobin, planned UD, neoadjuvant chemotherapy, and cT stage. USC pentafecta was defined as the combination at 1 year after surgery of: negative soft tissue surgical margins, ≥16 lymph node (LN) yield, absence of major (Clavien-Dindo Grade ≥III) complications at 90 days, absence of UD-related long-term sequalae, and absence of clinical recurrence. Trifecta was defined as the coexistence of daytime urinary continence, absence of major complications and recurrence-free status, all assessed at 1 year. Continuous and categorical variables were compared using Student's t-test and chi-square test, respectively. Univariable logistic regression analysis was performed to assess the role of USC pentafecta and trifecta achievement on health-related quality of life (HRQoL). RESULTS: There was no statistically significant difference in USC pentafecta and trifecta achievement between groups. Among secondary outcomes, univariable logistic regression analysis was performed and both 1-year USC pentafecta and trifecta achievement were predictors of 2-year unmodified global HRQoL. CONCLUSIONS: This study supports equivalence of RARC-iUD and ORC with regard to surgical quality as described by the USC pentafecta and trifecta. We described a significant impact of USC pentafecta and trifecta achievement on global health status/HRQoL, providing a strict correlation between objective evaluation of surgical outcomes and self-reported HRQoL.