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: 8188187
• 负责人: DIPEN PAREKH
• 金额: $ 68万
• 依托单位: UNIVERSITY OF TEXAS HLTH SCIENCE CENTER
• 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/8188187
• 关键词: Activities of Daily Living; Address; Area; Blood Transfusion; Cancer Control; Cancer Patient; Case Series; Clinical Trials; Complication; Cystectomy; Data; Effectiveness; Evaluation; Event; Funding; Future; Goals; Gold; Hand; Harvest; Hemorrhage; Hospitals; Inferior; Institution; Knowledge; Learning; Length of Stay; Life; Living Costs; Malignant Neoplasms; Malignant neoplasm of urinary bladder; Marketing; Measures; Mission; Morbidity - disease rate; Muscle; Operative Surgical Procedures; Outcome; Outcome Study; Patients; Performance; Perioperative; Phase; Postoperative Period; Progression-Free Survivals; Quality of life; Questionnaires; Radical Cystectomy; Randomized; Randomized Clinical Trials; Randomized Controlled Trials; Recovery; Recovery of Function; Reporting; Research; Resources; Robot; Robotics; Societies; Surgical margins; System; Technology; Testing; Time; Uncertainty; United States National Institutes of Health; Walking; base; burden of illness; cancer therapy; comparative effectiveness; compare effectiveness; cost; design; disability; experience; functional outcomes; grasp; health care service utilization; health related quality of life; improved; indexing; instrumental activity of daily living; lymph nodes; new technology; operation; 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 perioperative outcomes and time to functional recovery without compromising on the oncologic effectiveness. If RARC presumably results in favorable perioperative and functional outcomes, its routine use in surgical treatment of bladder cancer may not be justifiable if it results in inferior oncologic effectiveness and control compared to traditional ORC. Moreover, RARC is being marketed as superior to the traditional operation without systematic comparative effectiveness evaluations through randomized trials. To date, most outcome studies of RARC are either case series reports or comparative effectiveness studies with major methodological limitations. 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 clinical trial comparing long term oncologic and functional outcomes between RARC and ORC for bladder cancer patients to rigorously evaluate the impact of RARC compared to ORC. We will measure 2-year progression free survival, overall survival, perioperative morbidity patient reported and performance related measures of functional independence, quality of life and cost outcomes in each group. Our accrual goal of a total of 320 patients will adequately power the study using a non inferiority design with a predefined non inferiority margin of 15%. The importance of conducting our proposed trial is validated by the active participation of 13 tertiary care academic centers in our proposal. 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 along with the wealth of experience accruing patients to NIH-funded randomized controlled trials 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. PUBLIC HEALTH RELEVANCE: The use of surgical robot has the potential to significantly improve recovery and decrease morbidity in patients with bladder cancer compared to the traditional open surgery. However, the robotic technology is associated with a steep learning curve, perceived as more expensive with uncertainty about long term cancer related outcomes. Optimal utilization of health care resources is a critical issue faced by our society at present. Our proposed clinical trial will be the first definitive comparative effectiveness study comparing robotic and open approach to surgery with regards to long term cancer outcomes, recovery, perioperative morbidity, costs and quality of life that will help influence future surgical approaches in patients with bladder cancer.

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。已经假设机器人辅助自由基膀胱切除术（RARC）显着改善了围手术期的结果和功能恢复的时间，而不会损害肿瘤学有效性。如果RARC可能会导致有利的围手术期和功能结果，那么如果与传统兽人相比，它在外科手术治疗膀胱癌中的常规使用可能是不合理的。此外，RARC的销售优于传统操作，而没有通过随机试验进行系统的比较有效性评估。迄今为止，RARC的大多数结果研究是病例系列报告或具有重大方法论局限性的比较有效性研究。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3阶段多机构的随机临床试验，以比较长期的肿瘤学和功能结果，而RARC和ORC之间的RARC和ORC之间的功能性结果则严格评估RARC与ORC的影响。我们将衡量2年的自由生存，总生存期，围手术期发病患者报告的以及相关的功能独立性，生活质量和每组成本成本的措施。我们的总共320名患者的应计目标将使用非自卑设计为研究提供足够的能力，而预定义的非自卑感为15％。通过13个三级护理学术中心在我们的建议中积极参与的积极参与来验证我们提出的试验的重要性。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。在每个参与机构中进行的大量自由基囊肿以及获得NIH资助的随机对照试验的丰富经验使自己的应计值和参与意愿的机会显着更高。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。 公共卫生相关性：与传统的开放手术相比，手术机器人的使用有可能显着改善膀胱癌患者的恢复和发病率。但是，机器人技术与陡峭的学习曲线有关，认为与长期癌症相关的结果的不确定性更加昂贵。最佳利用医疗保健资源是目前我们社会面临的关键问题。我们提出的临床试验将是第一项确定性的比较有效性研究，比较了手术的机器人和开放式手术方法与长期癌症结局，康复，围手术期发病率，成本和生活质量有关，这将有助于影响膀胱癌患者未来的手术方法。