Open Vs Robotic-Assisted Radical Cystectomy: A Randomized Trial
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ClinicalTrials.gov Identifier: NCT01157676 |
Recruitment Status :
Completed
First Posted : July 7, 2010
Results First Posted : January 13, 2020
Last Update Posted : November 3, 2020
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Sponsor:
University of Miami
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Dipen J Parekh, MD, University of Miami
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Tracking Information | ||||
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First Submitted Date ICMJE | June 30, 2010 | |||
First Posted Date ICMJE | July 7, 2010 | |||
Results First Submitted Date ICMJE | February 11, 2019 | |||
Results First Posted Date ICMJE | January 13, 2020 | |||
Last Update Posted Date | November 3, 2020 | |||
Study Start Date ICMJE | July 2011 | |||
Actual Primary Completion Date | December 2018 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
Conduct a prospective, randomized trial to compare time to recovery after open versus robotic assisted radical cystectomy with pelvic lymph node dissection. [ Time Frame: 24 months ] | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
Cost [ Time Frame: Day 7 ] Fixed and variable costs associated with the procedure.
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Original Secondary Outcome Measures ICMJE | Not Provided | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Open Vs Robotic-Assisted Radical Cystectomy: A Randomized Trial | |||
Official Title ICMJE | Open Vs Robotic-Assisted Radical Cystectomy: A Randomized Trial | |||
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 | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Not Applicable | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: Non inferiority phase 3 randomized clinical trial comparing robotic to open radical cystectomy Masking: None (Open Label)Primary Purpose: Treatment |
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Condition ICMJE | Bladder Cancer Requiring Cystectomy | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
350 | |||
Original Estimated Enrollment ICMJE |
70 | |||
Actual Study Completion Date ICMJE | December 2018 | |||
Actual Primary Completion Date | December 2018 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01157676 | |||
Other Study ID Numbers ICMJE | 20120408 R01CA155388 ( U.S. NIH Grant/Contract ) 36911 ( Other Identifier: Investigator-Assigned ID ) |
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Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Current Responsible Party | Dipen J Parekh, MD, University of Miami | |||
Original Responsible Party | Dipen Parekh, MD, the Univesity of Texas Health Science Center at San Antonio | |||
Current Study Sponsor ICMJE | University of Miami | |||
Original Study Sponsor ICMJE | The University of Texas Health Science Center at San Antonio | |||
Collaborators ICMJE | National Cancer Institute (NCI) | |||
Investigators ICMJE |
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PRS Account | University of Miami | |||
Verification Date | October 2020 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |