MP56-05: Impact of comprehensive measurement of Surgical Outcomes on Subjective assessment of Health Related Quality of Life in patients receiving Radical Cystectomy with orthotopic Padua Ileal Bladder: single center randomized controlled trial
Introduction: Functional outcomes of Radical Cystectomy (RC) with orthotopic padua ileal bladder (PIB) are poorly reported and their impact on HRQoL underivestigated. We evaluated impact of trifecta and tetrafecta achievement on global health status from an ongoing RCT (NCT03434132).
Methods: Inclusion criteria were: diagnostic TURBt with cT2-4cN0cM0, or recurrent HG NMIBC and no anesthesiologic contraindications to RARC. Between Jan 2018 and Sept 2020 patients were enrolled with a covariate adaptive randomization process based on BMI, ASA, baseline hgb, UD, neoadjuvant chemo and cTstage. We previously described Trifecta as the combination of day continence, no major complication (CD=3) and recurrence-free status, at 1yr. Tetrafecta also included night continence. Global health status/QoL (QL) was evaluated from EORTC QLQC30 questionnaires. Satisfactory HRQoL outcome was defined as 1yr QL decrease <10% from baseline. Continuous and categorical variables were compared using Student t and Chi-Square tests. Logistic regression analysis was performed to assess the role of trifecta achievement on HRQoL.
Results: Out of 116 patients enrolled 88 underwent PIB and 75 reached a minimum follow-up of 1yr. Baseline clinical features were reported Tab 1. Trifecta was achieved in 41 patients (55%) while tetrafecta in 17 (23%). Trifecta achievement had a significant impact on QL patients who achieved trifecta had a lower probability (34%) to observe a QL decrease=10% compared with patients who did not achieve trifecta (62%) (p=0.021). Tetrafecta achievement had a negligible impact on QL (29% and 52%, tetrafecta achieved vs tetrafecta not achieved p=0.166) suggesting a minor impact of night continence on HRQoL (Fig 1). At logistic regression analysis patients who achieved trifecta had 68% lower probability to experience an overall QL decrease=10% (OR 0.321, 95% CI 0.125-0.827; p=0.019)
Conclusions: This study described a significant impact of trifecta on HRQoL, providing a strict correlation between objective evaluation of surgical outcomes and self reported HRQoL. Tetrafecta seems to play a negligible role on HRQoL, even if a larger cohort is needed to establish the HRQoL impact of night urinary continence.
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