Introduction: Radical Cystectomy (RC) with urinary diversion (UD) is still considered a complex surgery associated with significant morbidity and impact on daily life activity. Available Literature on cost-analysis missed to consider the impact of RC on patients’ role functioning (RF) and financial difficulties (FI). In this study, we performed an interim analysis from an ongoing randomised controlled trial (RCT) comparing ORC and RARC with totally intracorporeal UD (Clinical Trials: NCT03434132).
Methods: Patients were eligible for randomization if they had a diagnostic TURBt with T2-4, N0-N1, M0, or recurrent high-grade non-muscle invasive bladder cancer (BC) and no anesthesiologic contraindications to robotic surgery. From January 2018 to date, 62 patients were randomised into ORC or RARC arm based on the following variables: gender, BMI, ASA score, preoperative Hemoglobin, planned UD (intracorporeal ileal neobladder or conduit), neoadiuvant chemotherapy and clinical T-stage. Prospective evaluation of hospital costs factors was listed, such as: operative time (OT), length of stay (LoS), adherence to ERAS protocol and surgical procedure’s costs. Impact of RC on daily life work activities was evaluated collecting self-assessed questionnaires EORTC generic (QLQ-C30). The following items were analysed: baseline vs 1-yr RF and FI. Categorical and continuous variables were compared with Chi-square and Student t tests, respectively.
Results: At interim analysis of first 58 consecutive patients enrolled (30 RARC, 28 ORC, 50% of estimated sample size), OT (p<0.001] and surgical devices costs (p<0.001] were significantly higher for robotic approach. Instead, any statistically significant difference between groups was found for adherence to ERAS protocol (p=0.871) and LoS (p=0.464] (Tab.1). At 1-yr follow-up, ORC patients reported a significant reduction of RF (p=0.027) and FI (p=0.045) (Tab.2).
Conclusions: Preliminary data from interim analysis confirm significantly higher hospital costs of RARC. These costs could be counterbalanced by a faster return to daily life and to job activities, and by lower incidence of financial difficulties. The impact of these items on global cost analysis for national health system requires further analysis with larger sample size and longer follow-up. Source of