Finished
Open Vs Robotic-Assisted Radical Cystectomy: A Randomized Trial
NCT01157676 · University of Miami · Updated 3 Nov 2020
- What is being tested
- Open radical cystectomy; Robotic assisted radical cystectomy; DaVinci robot
- For
- Bladder Cancer Requiring Cystectomy
- Kind of study
- Tests a treatment or device on volunteers. No drug phase (a device or procedure study).
- Who can join
- Ages 18 years and older. About 350 people. The full rules are on the registry page.
- Where
- United States (16 sites)
- When
- Starts or started July 2011, ends Dec 2018. Registered 7 July 2010.
- Results
- Posted on the registry on 13 Jan 2020.
In the researchers' words
This is a multi-institutional, randomized trial evaluating oncologic, perioperative, and functional outcomes following two standard care procedures for radical cystectomy. The participants will have one of the standard care procedures as part of their care. The two procedures that will be followed are open radical cystectomy and robotic assisted radical cystectomy (RARC). Open cystectomy is considered to be the more traditional approach. While newer, RARC is considered to be equivalent to open surgery when it is performed by a trained robotics surgeon. The reported complication rates of RARC appear comparable to open surgery. This means there is no significant difference in the risk between the two standard procedures. However, despite these potential advantages, true comparison between the open and robotic technique with regards to long term cancer related and functional outcomes has not been accomplished because previous studies did not compare patients of equal health status. The researchers hope to learn whether or not patients undergoing RARC recover more quickly than or at the same rate as patients undergoing an open radical cystectomy while having non inferior cancer related outcomes. This study is funded by the National Institutes of Health (NIH).
Sites
- Mayo Clinic ArizonaPhoenix, Arizona, United States
- University of California, Irvine Medical Center (UC Irvine)Orange, California, United States
- Stanford UniversityStanford, California, United States
- University of MiamiMiami, Florida, United States
- University of Chicago Medical CenterChicago, Illinois, United States
- Loyola University Medical CenterMaywood, Illinois, United States
- Brigham and Women's HospitalBoston, Massachusetts, United States
- University of Michigan Health SystemAnn Arbor, Michigan, United States
- University of MinnesotaMinneapolis, Minnesota, United States
- Mayo ClinicRochester, Minnesota, United States
- University of North CarolinaChapel Hill, North Carolina, United States
- Ohio State University Medical CenterColumbus, Ohio, United States
- Vanderbilt University Medical CenterNashville, Tennessee, United States
- The University of Texas Health Science Center at San Antonio, Medical Arts & Research CenterSan Antonio, Texas, United States
- University of Virginia Health Science Center, Department of UrologyCharlottesville, Virginia, United States
- Cancer Research and Biostatistics (Data Management and Statistical Office)Seattle, Washington, United States
