BJU Int. 2023 Jul 20. doi: 10.1111/bju.16134. Online ahead of print.
ABSTRACT
OBJECTIVES: to compare USC pentafecta and trifecta achievement comparing open radical cystectomy (ORC) vs robot-assisted RC (RARC) with totally intracorporeal UD (i-UD) from a randomised controlled trial (RCT) MATERIALS AND METHODS: Patients were eligible for randomization if they had a diagnostic TURBt with cT2-4, cN0, cM0, or recurrent HG NMIBC and no anesthesiologic contraindications to robotic surgery. Patients were enrolled with a covariate adaptive randomization process based on the following variables: BMI, ASA score, preoperative haemoglobin, planned UD, neoadjuvant chemotherapy and cT-stage. USC pentafecta was defined as the combination, 1-yr after surgery, of negative soft tissue surgical margins, ≥ 16 lymph node (LN) yield, absence of major (Clavien≥3) 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 t and Chi-Square tests, respectively. Univariable logistic regression analysis was performed to assess the role of USC pentafecta and trifecta achievement on HRQoL.
RESULTS: No statistically significant difference was observed in USC pentafecta and trifecta achievement between groups. Among secondary outcomes, univariable logistic regression analysis was performed and both 1yr USC Pentafecta and trifecta achievement were predictors of 2yrs unmodified global QoL.
CONCLUSIONS: This study supports equivalence of RARC-iUD and ORC with regard to surgical quality as described by USC pentafecta and trifecta. We described a significant impact of USC pentafecta and trifecta achievement on global health status/QoL, providing a strict correlation between objective evaluation of surgical outcomes and self-reported HRQoL.
PMID:37470132 | DOI:10.1111/bju.16134
