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Randomized Controlled Trial
. 2023 May;209(5):901-910.
doi: 10.1097/JU.0000000000003201. Epub 2023 Feb 1.

Health-related Quality of Life After Robotic-assisted vs Open Radical Cystectomy: Analysis of a Randomized Trial

Affiliations
Randomized Controlled Trial

Health-related Quality of Life After Robotic-assisted vs Open Radical Cystectomy: Analysis of a Randomized Trial

Matthew B Clements et al. J Urol. 2023 May.

Abstract

Purpose: We compare health-related quality of life using a broad range of validated measures in patients randomized to robotic-assisted radical cystectomy vs open radical cystectomy.

Methods: We retrospectively analyzed patients that had enrolled in both a randomized controlled trial comparing robotic-assisted laparoscopic radical cystectomy vs open radical cystectomy and a separate prospective study of health-related quality of life. The prospective health-related quality of life study collected 14 patient-reported outcomes measures preoperatively and at 3, 6, 12, 18, and 24 months postoperatively. Linear mixed-effects models with an interaction term (study arm×time) were used to test for differences in mean domain scores and differing effects of approach over time, adjusting for baseline scores.

Results: A total of 72 patients were analyzed (n=32 robotic-assisted radical cystectomy, n=40 open radical cystectomy). From 3-24 months post-radical cystectomy, no significant differences in mean scores were detected. Mean differences were small in the following European Organization for Research and Treatment of Cancer QLQ-C30 (Core Quality of Life Questionnaire) domains: Global Quality of Life (-1.1; 95% CI -8.4, 6.2), Physical Functioning (-0.4; 95% CI -5.8, 5.0), Role Functioning (0.7; 95% CI -8.6, 10.0). Mean differences were also small in bladder cancer-specific domains (European Organization for Research and Treatment of Cancer QLQ-BLM30 [Muscle Invasive Bladder Cancer Quality of Life Questionnaire]): Body Image (2.9; 95% CI -7.2, 13.1), Urinary Symptoms (8.0; 95% CI -3.0, 19.0). In Urostomy Symptoms, there was a significant interaction term (P < .001) due to lower open radical cystectomy scores at 3 and 24 months. Other domains evaluating urinary, bowel, sexual, and psychosocial health-related quality of life were similar.

Conclusions: Over a broad range of health-related quality of life domains comparing robotic-assisted radical cystectomy and open radical cystectomy, there are unlikely to be clinically relevant differences in the medium to long term, and therefore health-related quality of life over this time period should not be a consideration in choosing between approaches.

Keywords: carcinoma; cystectomy; quality of life; robotic surgical procedures; transitional cell; urinary bladder neoplasms.

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Conflict of interest statement

Conflict of Interest: The Authors have no conflicts of interest to disclose.

Figures

Figure 1.
Figure 1.
Randomization of study patients. The dashed line indicates analysis off of the initial trial protocol. ORC indicates open radical cystectomy; QOL, quality of life; RARC, robotic-assisted radical cystectomy; RC, radical cystectomy.
Figure 2.
Figure 2.
Linear mixed-effects model estimates of mean scores over 24 months of follow-up for selected domains comparing open radical cystectomy (blue) and robotic-assisted radical cystectomy (orange). Models are adjusted for baseline domain scores. EORTC indicates European Organization for Research and Treatment of Cancer; QLQ-BLM30, Muscle Invasive Bladder Cancer Quality of Life Questionnaire; QLQ-C30, Core Quality of Life Questionnaire; QOL, quality of life; RC, radical cystectomy.
Figure 3.
Figure 3.
Linear mixed-effects model estimates of mean scores over 24 months of follow-up for selected domains comparing open radical cystectomy (blue) and robotic-assisted radical cystectomy (orange). Models are adjusted for baseline domain scores. DCS indicates Decisional Conflict Scale; EORTC, European Organization for Research and Treatment of Cancer; FRQ, Fear of Recurrence Questionnaire; IIQ, Incontinence Impact Questionnaire; MHI, Mental Health Inventory; MSK BFI, Memorial Sloan Kettering Cancer Center Bowel Function Index; QLQ-BLM30, Muscle Invasive Bladder Cancer Quality of Life Questionnaire; RC, radical cystectomy; SWLS, Satisfaction With Life Scale.

Comment in

References

    1. Hu JC, Chughtai B, O'Malley P, et al. Perioperative outcomes, health care costs, and survival after robotic-assisted versus open radical cystectomy: a national comparative effectiveness study. Eur Urol. 2016;70(1):195–202. - PubMed
    1. Bochner B, Dalbagni G, Sjoberg D, et al. Comparing open radical cystectomy and robot-assisted laparoscopic radical cystectomy: a randomized clinical trial. Eur Urol. 2015;67(6):1042–1050. - PMC - PubMed
    1. Parekh D, Reis I, Castle E, et al. Robot-assisted radical cystectomy versus open radical cystectomy in patients with bladder cancer (RAZOR): an open-label, randomised, phase 3, non-inferiority trial. Lancet. 2018;391(10139):2525–2536. - PubMed
    1. Becerra M, Venkatramani V, Reis I, et al. Health related quality of life of patients with bladder cancer in the RAZOR trial: a multi-institutional randomized trial comparing robot versus open radical cystectomy. J Urol. 2020;204(3):450–459. - PubMed
    1. Venkatramani V, Reis I, Gonzalgo M, et al. Comparison of robot-assisted and open radical cystectomy in recovery of patient-reported and performance-related measures of independence: a secondary analysis of a randomized clinical trial. JAMA Netw Open. 2022;5(2):e2148329. - PMC - PubMed

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