Open Vs Robotic-Assisted Radical Cystectomy: A Randomized Trial
This trial is active, not recruiting.
|Condition||bladder cancer requiring cystectomy|
|Treatments||quality of life questionnaires, get up and go test, hand grip test|
|Sponsor||University of Miami|
|Collaborator||National Cancer Institute (NCI)|
|Start date||March 2009|
|End date||November 2017|
|Trial size||350 participants|
|Trial identifier||NCT01157676, 20120408, 36911, R01CA155388|
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).
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Phoenix, AZ||Mayo Clinic Arizona||no longer recruiting|
|Orange, CA||University of California, Irvine Medical Center (UC Irvine)||no longer recruiting|
|Stanford, CA||Stanford University||no longer recruiting|
|Miami, FL||University of Miami||no longer recruiting|
|Chicago, IL||University of Chicago Medical Center||no longer recruiting|
|Maywood, IL||Loyola University Medical Center||no longer recruiting|
|Boston, MA||Brigham and Women's Hospital||no longer recruiting|
|Ann Arbor, MI||University of Michigan Health System||no longer recruiting|
|Minneapolis, MN||University of Minnesota||no longer recruiting|
|Rochester, MN||Mayo Clinic||no longer recruiting|
|Chapel Hill, NC||University of North Carolina||no longer recruiting|
|Columbus, OH||Ohio State University Medical Center||no longer recruiting|
|Nashville, TN||Vanderbilt University Medical Center||no longer recruiting|
|San Antonio, TX||The University of Texas Health Science Center at San Antonio, Medical Arts & Research Center||no longer recruiting|
|Charlottesville, VA||University of Virginia Health Science Center, Department of Urology||no longer recruiting|
|Seattle, WA||Cancer Research and Biostatistics (Data Management and Statistical Office)||no longer recruiting|
Determine if RARC provides a non inferior oncologic control to open radical cystectomy, as measure by two-year progression free survival.
time frame: 36 months
Male or female participants at least 18 years old.
Inclusion Criteria: 1. Patient must have biopsy proven bladder cancer. Official pathology report reviewed at the participating institution is required. 2. Bladder cancer must be clinical stage T1-T4, N0-1, M0. (AJCC 7th edition) or refractory cis (carcinoma in situ). Exclusion Criteria: 1. Inability to give informed consent. 2. Prior major abdominal and pelvic open surgical procedures that would preclude a safe robotic approach, as determined by the treating surgeon. 3. At the discretion of the treating surgeon, any pre-existing condition such as severe chronic obstructive pulmonary disease that precludes a safe initiation or maintenance of pneumoperitoneum over a prolonged period of time and during surgery. 4. Age <18 or >99 years. 5. Pregnancy.
|Official title||Open Vs Robotic-Assisted Radical Cystectomy: A Randomized Trial|
|Principal investigator||Dipen J Parekh, MD|
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