Abstract Background: Open radical cystectomy (ORC) is still considered the reference approach for RC, although robot-assisted RC (RARC) has recently gained in popularity. There are literature reports on perioperative and oncologic outcomes of RARC, but functional outcomes and aspects related to health-related quality of life (HRQoL) remain unexplored. Objective: To report an interim analysis of 1-yr HRQoL outcomes from an ongoing randomised controlled trial comparing ORC and RARC with totally intracorporeal urinary diversion (iUD) (ClinicalTrials.gov NCT03434132). Design, setting, and participants: Patients with cT2-4N0M0 non-muscle-invasive bladder cancer or bacillus Calmette-Guérin failure who were candidates for cystectomy with curative intent without absolute contraindications to robotic surgery were included. A covariate adaptive randomisation based on the following variables was used: body mass index, American Society of Anesthesiologists score, preoperative haemoglobin level, cT stage, type of UD, and neoadjuvant chemotherapy. Intervention: ORC or RARC with iUD. Outcome measurements and statistical analysis: Data from patient-reported European Organization for Research and Treatment of Cancer QoL questionnaires (QLQ-C30 and QLQ-BLM30) were collected at baseline and 1 yr. Continuous variables were compared using the Student t test. Results and limitations: At interim analysis, 51 patients (24 RARC, 27 ORC) were analysed. Overall, both groups reported significant worsening of body image and physical and sexual functions (all p ≤ 0.012). Patients receiving ORC were more likely to report significant 1-yr impairment of role functioning, symptoms scales and bowel symptoms (all p ≤ 0.048). Patients receiving RARC reported significant impairment of urinary symptoms and problems (p = 0.018). Conclusions: This study suggests equivalence between RARC-iUD and ORC for most HRQoL domains. Notwithstanding, after 1 yr patients receiving ORC were more likely to experience a decline in role functioning and higher symptoms scale, while RARC-iUD patients were more likely to report significant increases in urinary symptoms and problems. Patient summary: We analysed 1-year data for health-related quality of life from an ongoing trial comparing open and robotic surgery for removal of the bladder in patients with bladder cancer. Robotic surgery seems to provide benefits for most quality-of-life items on patient-reported questionnaires. This trial is registered at ClinicalTrial.gov as NCT03434132.

Comparison of Patient-reported Health-related Quality of Life Between Open Radical Cystectomy and Robot-assisted Radical Cystectomy with Intracorporeal Urinary Diversion: Interim Analysis of a Randomised Controlled Trial / Mastroianni, Riccardo; Tuderti, Gabriele; Anceschi, Umberto; Maria Bove, Alfredo; Brassetti, Aldo; Ferriero, Mariaconsiglia; Zampa, Ashanti; Giannarelli, Diana; Guaglianone, Salvatore; Gallucci, Michele; Simone, Giuseppe. - In: EUROPEAN UROLOGY FOCUS. - ISSN 2405-4569. - (2021). [10.1016/j.euf.2021.03.002]

Comparison of Patient-reported Health-related Quality of Life Between Open Radical Cystectomy and Robot-assisted Radical Cystectomy with Intracorporeal Urinary Diversion: Interim Analysis of a Randomised Controlled Trial

Riccardo Mastroianni;Gabriele Tuderti;Umberto Anceschi;Aldo Brassetti;Michele Gallucci;
2021

Abstract

Abstract Background: Open radical cystectomy (ORC) is still considered the reference approach for RC, although robot-assisted RC (RARC) has recently gained in popularity. There are literature reports on perioperative and oncologic outcomes of RARC, but functional outcomes and aspects related to health-related quality of life (HRQoL) remain unexplored. Objective: To report an interim analysis of 1-yr HRQoL outcomes from an ongoing randomised controlled trial comparing ORC and RARC with totally intracorporeal urinary diversion (iUD) (ClinicalTrials.gov NCT03434132). Design, setting, and participants: Patients with cT2-4N0M0 non-muscle-invasive bladder cancer or bacillus Calmette-Guérin failure who were candidates for cystectomy with curative intent without absolute contraindications to robotic surgery were included. A covariate adaptive randomisation based on the following variables was used: body mass index, American Society of Anesthesiologists score, preoperative haemoglobin level, cT stage, type of UD, and neoadjuvant chemotherapy. Intervention: ORC or RARC with iUD. Outcome measurements and statistical analysis: Data from patient-reported European Organization for Research and Treatment of Cancer QoL questionnaires (QLQ-C30 and QLQ-BLM30) were collected at baseline and 1 yr. Continuous variables were compared using the Student t test. Results and limitations: At interim analysis, 51 patients (24 RARC, 27 ORC) were analysed. Overall, both groups reported significant worsening of body image and physical and sexual functions (all p ≤ 0.012). Patients receiving ORC were more likely to report significant 1-yr impairment of role functioning, symptoms scales and bowel symptoms (all p ≤ 0.048). Patients receiving RARC reported significant impairment of urinary symptoms and problems (p = 0.018). Conclusions: This study suggests equivalence between RARC-iUD and ORC for most HRQoL domains. Notwithstanding, after 1 yr patients receiving ORC were more likely to experience a decline in role functioning and higher symptoms scale, while RARC-iUD patients were more likely to report significant increases in urinary symptoms and problems. Patient summary: We analysed 1-year data for health-related quality of life from an ongoing trial comparing open and robotic surgery for removal of the bladder in patients with bladder cancer. Robotic surgery seems to provide benefits for most quality-of-life items on patient-reported questionnaires. This trial is registered at ClinicalTrial.gov as NCT03434132.
2021
Keywords: Bladder cancer; Health-related quality of life; Open radical cystectomy; Randomised controlled trial; Robot-assisted radical cystectomy.
01 Pubblicazione su rivista::01l Trial clinico
Comparison of Patient-reported Health-related Quality of Life Between Open Radical Cystectomy and Robot-assisted Radical Cystectomy with Intracorporeal Urinary Diversion: Interim Analysis of a Randomised Controlled Trial / Mastroianni, Riccardo; Tuderti, Gabriele; Anceschi, Umberto; Maria Bove, Alfredo; Brassetti, Aldo; Ferriero, Mariaconsiglia; Zampa, Ashanti; Giannarelli, Diana; Guaglianone, Salvatore; Gallucci, Michele; Simone, Giuseppe. - In: EUROPEAN UROLOGY FOCUS. - ISSN 2405-4569. - (2021). [10.1016/j.euf.2021.03.002]
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11573/1616732
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