Open vs Robot-Assisted Radical Cystectomy: A Randomized Trial

描述(申请人提供)：开放根治性膀胱切除术(ORC)是目前肌肉浸润性膀胱癌的黄金标准治疗方法。虽然它与足够的生存结果相关，但它也与相当长的恢复时间和术后发病率有关。为了使手术侵入性更小，手术机器人的使用已经应用于膀胱癌患者。据推测，机器人辅助根治性膀胱切除术(RARC)在不影响肿瘤疗效的情况下，显著缩短了功能恢复的时间。第三阶段的前瞻性随机试验需要比较RARC和ORC的有效性来验证这一假设。为了与NIH追求研究和应用知识以延长健康寿命和减少疾病和残疾负担的使命保持一致，我们计划进行一项第三阶段多机构随机比较有效性临床试验，比较RARC和ORC对膀胱癌患者的肿瘤学和功能结果。我们将测量两年无进展存活率、总存活率、患者报告情况以及与功能独立性、围手术期发病率和生活质量相关的绩效指标。我们提议的13个三级护理学术中心积极参与我们的提议，验证了进行我们提议的试验的价值、兴趣和重要性。参与的临床机构包括德克萨斯大学圣安东尼奥健康科学中心、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、加州大学欧文医学中心、亚利桑那州斯科茨代尔的梅奥诊所、亨利·福特医疗系统、底特律、密歇根大学医学中心、洛约拉大学医学中心、明尼苏达大学医学中心、俄亥俄州立大学医学中心、弗吉尼亚大学夏洛茨维尔医学中心和北卡罗来纳大学医学中心。这项研究的结果将是确定RARC与ORC的比较有效性的关键，并有可能改变膀胱癌患者手术方式的护理标准。每个参与机构进行的根治性膀胱切除术的数量都非常大(每个机构每年都超过50次根治性膀胱切除术)，加上NIH资助的随机对照试验(如PCPT、MTOPS和SELECT)积累了丰富的患者经验，这本身就使患者获得收益的机会和参与意愿大大增加。在我们努力高效利用医疗资源的同时，评估新技术的真正有效性并确定较高的前期成本是否因其他领域的改进而合理，这一点至关重要。在市场的力量决定护理标准之前，有机会收集随机的、前瞻性的数据，将RARC与ORC进行比较。

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.