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Brief Title: Open Vs Robotic-Assisted Radical Cystectomy: A Randomized Trial
Official Title: Open Vs Robotic-Assisted Radical Cystectomy: A Randomized Trial
Study ID: NCT01157676
Brief Summary: 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).
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Mayo Clinic Arizona, Phoenix, Arizona, United States
University of California, Irvine Medical Center (UC Irvine), Orange, California, United States
Stanford University, Stanford, California, United States
University of Miami, Miami, Florida, United States
University of Chicago Medical Center, Chicago, Illinois, United States
Loyola University Medical Center, Maywood, Illinois, United States
Brigham and Women's Hospital, Boston, Massachusetts, United States
University of Michigan Health System, Ann Arbor, Michigan, United States
University of Minnesota, Minneapolis, Minnesota, United States
Mayo Clinic, Rochester, Minnesota, United States
University of North Carolina, Chapel Hill, North Carolina, United States
Ohio State University Medical Center, Columbus, Ohio, United States
Vanderbilt University Medical Center, Nashville, Tennessee, United States
The University of Texas Health Science Center at San Antonio, Medical Arts & Research Center, San Antonio, Texas, United States
University of Virginia Health Science Center, Department of Urology, Charlottesville, Virginia, United States
Cancer Research and Biostatistics (Data Management and Statistical Office), Seattle, Washington, United States
Name: Dipen J Parekh, MD
Affiliation: University of Miami
Role: PRINCIPAL_INVESTIGATOR