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.
|Effective start/end date||7/1/11 → 4/30/17|
- National Institutes of Health: $679,965.00
- National Institutes of Health: $555,870.00
- National Institutes of Health: $542,841.00
- National Institutes of Health: $783,812.00
- National Institutes of Health: $551,281.00