Division of Psychosocial Research and Epidemiology, The Netherlands Cancer Institute, Amsterdam, The Netherlands.
Center for Quality of Life, The Netherlands Cancer Institute, Amsterdam, The Netherlands.
BMJ Open. 2023 Mar 7;13(3):e071304. doi: 10.1136/bmjopen-2022-071304.
INTRODUCTION: Radical cystectomy (RC) is the standard treatment for patients with non-metastatic muscle-invasive bladder cancer, as well as for patients with therapy refractory high-risk non-muscle invasive bladder cancer. However, 50-65% of patients undergoing RC experience perioperative complications. The risk, severity and impact of these complications is associated with a patient's preoperative cardiorespiratory fitness, nutritional and smoking status and presence of anxiety and depression. There is emerging evidence supporting multimodal prehabilitation as a strategy to reduce the risk of complications and improve functional recovery after major cancer surgery. However, for bladder cancer the evidence is still limited. The aim of this study is to investigate the superiority of a multimodal prehabilitation programme versus standard-of-care in terms of reducing perioperative complications in patients with bladder cancer undergoing RC. METHODS AND ANALYSIS: This multicentre, open label, prospective, randomised controlled trial, will include 154 patients with bladder cancer undergoing RC. Patients are recruited from eight hospitals in The Netherlands and will be randomly (1:1) allocated to the intervention group receiving a structured multimodal prehabilitation programme of approximately 3-6 weeks, or to the control group receiving standard-of-care. The primary outcome is the proportion of patients who develop one or more grade ≥2 complications (according to the Clavien-Dindo classification) within 90 days of surgery. Secondary outcomes include cardiorespiratory fitness, length of hospital stay, health-related quality of life, tumour tissue biomarkers of hypoxia, immune cell infiltration and cost-effectiveness. Data collection will take place at baseline, before surgery and 4 and 12 weeks after surgery. ETHICS AND DISSEMINATION: Ethical approval for this study was granted by the Medical Ethics Committee NedMec (Amsterdam, The Netherlands) under reference number 22-595/NL78792.031.22. Results of the study will be published in international peer-reviewed journals. TRIAL REGISTRATION NUMBER: NCT05480735.
介绍：根治性膀胱切除术（RC）是治疗非转移性肌层浸润性膀胱癌以及治疗难治性高危非肌层浸润性膀胱癌患者的标准治疗方法。然而，50-65%接受 RC 的患者会发生围手术期并发症。这些并发症的风险、严重程度和影响与患者术前心肺功能适应性、营养和吸烟状况以及焦虑和抑郁的存在有关。有新的证据支持多模式术前康复作为降低主要癌症手术后并发症风险和改善功能恢复的策略。然而，对于膀胱癌，证据仍然有限。本研究旨在研究多模式术前康复方案与标准护理相比，在降低接受 RC 的膀胱癌患者围手术期并发症方面的优越性。
方法和分析：这是一项多中心、开放标签、前瞻性、随机对照试验，将纳入 154 例接受 RC 的膀胱癌患者。患者从荷兰的 8 家医院招募，并随机（1:1）分配到干预组（接受大约 3-6 周的结构化多模式术前康复方案）或对照组（接受标准护理）。主要结局是 90 天内发生 1 个或多个≥2 级并发症（根据 Clavien-Dindo 分类）的患者比例。次要结局包括心肺功能适应性、住院时间、健康相关生活质量、肿瘤组织缺氧生物标志物、免疫细胞浸润和成本效益。数据采集将在基线、手术前和手术后 4 周和 12 周进行。
伦理和传播：这项研究的伦理批准由 NedMec 医学伦理委员会（荷兰阿姆斯特丹）授予，注册号为 22-595/NL78792.031.22。研究结果将发表在国际同行评议期刊上。
试验注册号：NCT05480735。
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