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NCT01157676 · ClinicalTrials.gov registry record · NA
Open Vs Robotic-Assisted Radical Cystectomy: A Randomized Trial
A NA study of Bladder Cancer Requiring Cystectomy, sponsored by University of Miami.
- Completed
- Registry status
- NA
- Development phase
- 350
- Enrollment target
- 16
- Study locations
NCT01157676: Completed NA study of Bladder Cancer Requiring Cystectomy, sponsored by University of Miami.
NCT01157676 is a NA study of Bladder Cancer Requiring Cystectomy that has completed, run by University of Miami. The registered enrollment target is 350 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (75% lower). The trial reports 16 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01157676, a NA study of Bladder Cancer Requiring Cystectomy, has completed, sponsored by University of Miami.
- COMPLETED
- Registry status
- NA
- Development phase
- 350 participants
- Enrollment target
- 16
- Study locations
Study 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).
Primary Outcome
Progression will be determined by the treating physician using the Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 criteria based on radiographic or pathological evidence of disease progression or death from disease.
Conditions Studied
Interventions
- PROCEDURE Open radical cystectomy
- PROCEDURE Robotic assisted radical cystectomy
- DEVICE DaVinci robot
Study Locations (16)
California
- University of California, Irvine Medical Center (UC Irvine) - Orange
- Stanford University - Stanford
Illinois
- University of Chicago Medical Center - Chicago
- Loyola University Medical Center - Maywood
Minnesota
- University of Minnesota - Minneapolis
- Mayo Clinic - Rochester
Arizona
- Mayo Clinic Arizona - Phoenix
Florida
- University of Miami - Miami
Massachusetts
- Brigham and Women's Hospital - Boston
Michigan
- University of Michigan Health System - Ann Arbor
North Carolina
- University of North Carolina - Chapel Hill
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 350 participants |
| Start Date | 2011-07 |
| Est. Completion | 2018-12 |
| Phase | NA |
What the finished NCT01157676 record still lists
NCT01157676 is an interventional study that assigns participants to a tested intervention. The registered 350 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (75% lower).
The record links to 1 condition, with Bladder Cancer Requiring Cystectomy appearing as the primary indexed condition, and to 3 interventions - of which Open radical cystectomy is the first listed.
NCT01157676 lists 16 locations in 13 states (California, Illinois, Minnesota).
Frequently Asked Questions
What is clinical trial NCT01157676 about?
NCT01157676 is a clinical study titled "Open Vs Robotic-Assisted Radical Cystectomy: A Randomized Trial". 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 a...
What is the current status of trial NCT01157676?
This trial is currently completed. It is a NA study. The enrollment target is 350 participants. The study started on 2011-07. Estimated completion is 2018-12.
What conditions does trial NCT01157676 study?
This clinical trial studies the following conditions: Bladder Cancer Requiring Cystectomy.
What interventions are being tested in trial NCT01157676?
The interventions under investigation include: Open radical cystectomy (PROCEDURE), Robotic assisted radical cystectomy (PROCEDURE), DaVinci robot (DEVICE).
Who is sponsoring clinical trial NCT01157676?
This trial is sponsored by University of Miami, which has 721 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01157676 being conducted?
This trial has 16 study locations across Arizona, California, Florida, Illinois, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01157676's enrollment target sits among peer trials
350 292nd of 2000 higher than 1,699 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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