Open vs Robot-Assisted Radical Cystectomy: A Randomized Trial

开放与机器人辅助根治性膀胱切除术：随机试验

• 批准号: 8504084
• 负责人: DIPEN PAREKH
• 金额: $ 78.38万
• 依托单位: UNIVERSITY OF MIAMI SCHOOL OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-07-01 至 2016-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8504084
• 关键词: Academic Medical Centers; Activities of Daily Living; Address; Analgesics; Area; Arizona; Blood Transfusion; California; Cancer Control; Cancer Patient; Chicago; Clinic; Clinical; Clinical Trials; Cystectomy; Data; Day Surgery; Effectiveness; Funding; Future; Gold; Hand; Harvest; Health Sciences; Health system; Hemorrhage; Hospitals; Inferior; Institution; Knowledge; Learning; Length of Stay; Life; Liquid substance; Malignant Neoplasms; Malignant neoplasm of urinary bladder; Measurement; Measures; Medical center; Michigan; Minnesota; Mission; Morbidity - disease rate; Muscle; North Carolina; Ohio; Operative Surgical Procedures; Outcome; Patients; Performance; Perioperative; Phase; Postoperative Period; Progression-Free Survivals; Quality of life; Questionnaires; Radical Cystectomy; Randomized; Randomized Controlled Trials; Recovery; Recovery of Function; Reporting; Research; Resources; Robot; Robotics; Societies; Surgical complication; Surgical margins; System; Technology; Testing; Texas; Time; Uncertainty; United States; United States National Institutes of Health; Universities; Virginia; Walking; burden of illness; cancer therapy; comparative effectiveness; compare effectiveness; cost; design; disability; effectiveness clinical trial; experience; functional outcomes; grasp; health care service utilization; health related quality of life; improved; indexing; instrumental activity of daily living; interest; lymph nodes; new technology; prospective; randomized trial; robot assistance; standard care; standard of care; tertiary care; trial comparing; willingness

DESCRIPTION (provided by applicant): Open Radical Cystectomy (ORC) is currently the gold standard treatment for muscle-invasive bladder cancer. While it is associated with adequate survival outcomes, it is also associated with considerable recovery time and postoperative morbidity. With the intent of making the surgery less invasive, the use of surgical robot has been applied in patients with bladder cancer. It has been hypothesized that Robotic-Assisted Radical Cystectomy (RARC) significantly improves time to functional recovery without compromising on the oncologic effectiveness. Phase 3 prospective randomized trials comparing the effectiveness of RARC to ORC are needed to validate this hypothesis. In keeping with NIH's mission to pursue research and apply knowledge that extends healthy life and reduces the burdens of illness and disability, we plan on conducting a phase 3 multi-institutional randomized comparative effectiveness clinical trial comparing oncologic and functional outcomes between RARC and ORC for bladder cancer patients. We will measure 2 year progression free survival, overall survival, patient reported and performance related measures of functional independence, perioperative morbidity and quality of life in each group. The value, interest and importance of conducting our proposed trial is validated by the active participation of 13 tertiary care academic centers located across the United States in our proposal. The participating clinical institutions are the University of Texas Health Science Center San Antonio, University of Chicago Medical Center, Vanderbilt University Medical Center, Stanford University Medical Center, University of California at Irvine Medical Center, Mayo Clinic in Scottsdale, Arizona, Henry Ford Health System, Detroit, University of Michigan Medical Center, Loyola University Medical Center, University of Minnesota Medical Center, Ohio State University Medical Center, University of Virginia Medical Center at Charlottesville and University of North Carolina Medical Center. The results from this study will be critical to determining the comparative effectiveness of RARC compared with ORC and potentially change the standard of care in the surgical approach for patients with bladder cancer. The exceedingly high volume of radical cystectomies performed at each of the participating institutions (more than 50 radical cystectomies per year at each institution) along with the wealth of experience accruing patients to NIH-funded randomized controlled trials (e.g. PCPT, MTOPS and SELECT) lends itself to significantly higher chances of patient accrual and willingness to participate. As we strive toward efficient utilization of healthcare resources, it is critical that we evaluate the true effectiveness of new technologies and determine whether the higher upfront costs are justified by improvements in other areas. There is a window of opportunity to gather randomized, prospective data, comparing RARC to ORC before the forces of the marketplace determine the standard of care.

描述（由申请人提供）：开放自由基膀胱切除术（ORC）目前是肌肉侵入性膀胱癌的金标准治疗方法。虽然它与适当的生存结果相关，但它也与大量恢复时间和术后发病率有关。为了使手术侵入性降低，手术机器人的使用已应用于膀胱癌患者。据推测，机器人辅助自由基膀胱切除术（RARC）可显着改善功能恢复的时间，而不会损害肿瘤学有效性。需要比较RARC与兽人的有效性的前瞻性随机试验来验证这一假设。为了遵循NIH的使命，要进行研究和应用知识，以延长健康的生命并减少疾病和残疾的负担，我们计划进行第三阶段的三级机构随机比较有效性临床试验，以比较Bladder Cancer患者RARC和ORC之间的肿瘤学和功能结果。我们将衡量每组功能独立性，围手术期发病率和生活质量的2年无进展生存，总生存期，患者报告和与绩效相关的措施。进行我们建议的试验的价值，兴趣和重要性通过位于美国各地的13个三级护理学术中心的积极参与来验证我们的提案。参与的临床机构是德克萨斯大学健康科学中心圣安东尼奥大学，芝加哥大学医学中心，范德比尔特大学医学中心，斯坦福大学医学中心，加利福尼亚大学，伊利诺伊州医学中心的亨利·福特医学中心的亨利·福特医学中心的亨利·福特医学中心的亨利·福特卫生系统的梅奥诊所的欧文医学中心，梅奥诊所，梅奥诊所，诺里亚大学医学中心。夏洛茨维尔和北卡罗来纳大学医学中心的中心。与ORC相比，这项研究的结果对于确定RARC的比较有效性至关重要，并有可能改变膀胱癌患者的手术方法中的护理标准。在每个参与机构（每个机构每年超过50多个自由基囊肿）进行的自由基囊切除术以及获得NIH资助的随机对照试验的丰富经验（例如，PCPT，MTOPS和SELECT）具有显着更高的愿意参与患者的机会。当我们努力有效利用医疗保健资源时，至关重要的是，我们必须评估新技术的真正有效性，并确定较高的前期成本是否通过其他领域的改进来证明是合理的。有机会收集随机，前瞻性数据，将RARC与兽人进行比较，然后在市场力量决定护理标准之前。