Department of Urology, Lahey Hospital & Medical Center, Burlington, Massachusetts.
Urology Service, Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, New York.
J Urol. 2023 May;209(5):901-910. doi: 10.1097/JU.0000000000003201. Epub 2023 Feb 1.
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.
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.
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 ( < .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.
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.
我们比较了接受机器人辅助根治性膀胱切除术与开放性根治性膀胱切除术的患者在使用广泛的经过验证的测量方法后的健康相关生活质量。
我们回顾性分析了同时参加了一项比较机器人辅助腹腔镜根治性膀胱切除术与开放性根治性膀胱切除术的随机对照试验和一项健康相关生活质量的前瞻性研究的患者。前瞻性健康相关生活质量研究在术前和术后 3、6、12、18 和 24 个月时收集了 14 项患者报告的结果测量指标。使用带有交互项（研究臂×时间）的线性混合效应模型来测试平均域评分的差异和随时间推移的不同方法的不同影响，同时调整基线评分。
共分析了 72 例患者（机器人辅助根治性膀胱切除术 32 例，开放性根治性膀胱切除术 40 例）。从根治性膀胱切除术后 3 至 24 个月，未发现平均评分有显著差异。在欧洲癌症研究与治疗组织（EORTC）QLQ-C30（核心生活质量问卷）的以下领域中，平均差异较小：全球健康状况（-1.1；95%置信区间-8.4，6.2），身体功能（-0.4；95%置信区间-5.8，5.0），角色功能（0.7；95%置信区间-8.6，10.0）。在膀胱癌特异性领域（EORTC QLQ-BLM30[肌肉浸润性膀胱癌生活质量问卷]）中，平均差异也较小：身体形象（2.9；95%置信区间-7.2，13.1），尿症状（8.0；95%置信区间-3.0，19.0）。在尿流改道症状方面，由于术后 3 个月和 24 个月时开放根治性膀胱切除术的评分较低，因此存在显著的交互项（<0.001）。评估尿、肠、性和心理社会健康相关生活质量的其他领域相似。
在广泛的健康相关生活质量领域比较机器人辅助根治性膀胱切除术与开放性根治性膀胱切除术，从中长期来看，不太可能存在临床相关的差异，因此在选择治疗方法时，这一时期的健康相关生活质量不应作为考虑因素。
