Open Vs Robotic-Assisted Radical Cystectomy: A Randomized Trial
Public ClinicalTrials.gov record NCT01157676. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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).
Study identification
- NCT ID
- NCT01157676
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 350 participants
Conditions and interventions
Conditions
Interventions
- Open radical cystectomy Procedure
- Robotic assisted radical cystectomy Procedure
- DaVinci robot Device
Procedure · Device
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 2011 (Type not available)
- Primary completion
- Dec 2018 (Actual)
- Completion
- Dec 2018 (Actual)
- Last update posted
- Nov 3, 2020
2011 – 2018
United States locations
- U.S. sites
- 16
- U.S. states
- 13
- U.S. cities
- 16
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Mayo Clinic Arizona | Phoenix | Arizona | 85054 | — |
| University of California, Irvine Medical Center (UC Irvine) | Orange | California | 92868 | — |
| Stanford University | Stanford | California | 94305 | — |
| University of Miami | Miami | Florida | 33136 | — |
| University of Chicago Medical Center | Chicago | Illinois | 60637 | — |
| Loyola University Medical Center | Maywood | Illinois | 60153 | — |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | — |
| University of Michigan Health System | Ann Arbor | Michigan | 48109 | — |
| University of Minnesota | Minneapolis | Minnesota | 55455 | — |
| Mayo Clinic | Rochester | Minnesota | 55905 | — |
| University of North Carolina | Chapel Hill | North Carolina | 27599 | — |
| Ohio State University Medical Center | Columbus | Ohio | 43210 | — |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | — |
| The University of Texas Health Science Center at San Antonio, Medical Arts & Research Center | San Antonio | Texas | 78229 | — |
| University of Virginia Health Science Center, Department of Urology | Charlottesville | Virginia | 22908 | — |
| Cancer Research and Biostatistics (Data Management and Statistical Office) | Seattle | Washington | 98101 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01157676, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Nov 3, 2020 · Synced Oct 20, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01157676 live on ClinicalTrials.gov.