ObjectivesTo compare University of Southern California (USC) Institute of Urology pentafecta and trifecta achievement comparingopen radical cystectomy (ORC) vs robot-assisted RC (RARC) with totally intracorporeal urinary diversion (iUD) from arandomised controlled trial (RCT).Patients and MethodsPatients were eligible for randomisation if they had a diagnostic transurethral resection of bladder tumour with clinical Tstage (cT)2–4, cN0, cM0, or recurrent high-grade non-muscle-invasive bladder cancer and no anaesthesia contraindicationsto 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, neoadjuvantchemotherapy, and cT stage. USC pentafecta was defined as the combination at 1 year after surgery of: negative soft tissuesurgical 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 ofdaytime urinary continence, absence of major complications and recurrence-free status, all assessed at 1 year. Continuousand categorical variables were compared using Student’st-test and chi-square test, respectively. Univariable logisticregression analysis was performed to assess the role of USC pentafecta and trifecta achievement on health-related quality oflife (HRQoL).ResultsThere was no statistically significant difference in USC pentafecta and trifecta achievement between groups. Amongsecondary outcomes, univariable logistic regression analysis was performed and both 1-year USC pentafecta and trifectaachievement were predictors of 2-year unmodified global HRQoL.ConclusionsThis study supports equivalence of RARC-iUD and ORC with regard to surgical quality as described by the USC pentafectaand 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
Open versus robot-assisted radical cystectomy: pentafecta and trifecta achievement comparison from a randomised controlled trial / Mastroianni, Riccardo; Tuderti, Gabriele; Ferriero, Mariaconsiglia; Anceschi, Umberto; Maria Bove, Alfredo; Brassetti, Aldo; Misuraca, Leonardo; D'Annunzio, Simone; Guaglianone, Salvatore; Gallucci, Michele; Simone, Giuseppe. - In: BJU INTERNATIONAL. - ISSN 1464-410X. - (2023). [10.1111/bju.16134]
Open versus robot-assisted radical cystectomy: pentafecta and trifecta achievement comparison from a randomised controlled trial
Riccardo Mastroianni;Gabriele Tuderti;Umberto Anceschi;Aldo Brassetti;Leonardo Misuraca;Simone D'Annunzio;Michele Gallucci;
2023
Abstract
ObjectivesTo compare University of Southern California (USC) Institute of Urology pentafecta and trifecta achievement comparingopen radical cystectomy (ORC) vs robot-assisted RC (RARC) with totally intracorporeal urinary diversion (iUD) from arandomised controlled trial (RCT).Patients and MethodsPatients were eligible for randomisation if they had a diagnostic transurethral resection of bladder tumour with clinical Tstage (cT)2–4, cN0, cM0, or recurrent high-grade non-muscle-invasive bladder cancer and no anaesthesia contraindicationsto 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, neoadjuvantchemotherapy, and cT stage. USC pentafecta was defined as the combination at 1 year after surgery of: negative soft tissuesurgical 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 ofdaytime urinary continence, absence of major complications and recurrence-free status, all assessed at 1 year. Continuousand categorical variables were compared using Student’st-test and chi-square test, respectively. Univariable logisticregression analysis was performed to assess the role of USC pentafecta and trifecta achievement on health-related quality oflife (HRQoL).ResultsThere was no statistically significant difference in USC pentafecta and trifecta achievement between groups. Amongsecondary outcomes, univariable logistic regression analysis was performed and both 1-year USC pentafecta and trifectaachievement were predictors of 2-year unmodified global HRQoL.ConclusionsThis study supports equivalence of RARC-iUD and ORC with regard to surgical quality as described by the USC pentafectaand 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 HRQoLI documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
