Bladder Cancer Clinical Trial

Open Vs Robotic-Assisted Radical Cystectomy: A Randomized Trial

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).

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Patient must have biopsy proven bladder cancer. Official pathology report reviewed at the participating institution is required.
Bladder cancer must be clinical stage T1-T4, N0-1, M0. (AJCC 7th edition) or refractory cis (carcinoma in situ).

Exclusion Criteria:

Inability to give informed consent.
Prior major abdominal and pelvic open surgical procedures that would preclude a safe robotic approach, as determined by the treating surgeon.
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.
Age <18 or >99 years.
Pregnancy.

Study is for people with:

Bladder Cancer

Estimated Enrollment:

350

Study ID:

NCT01157676

Recruitment Status:

Completed

Sponsor:

University of Miami

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There are 16 Locations for this study

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Mayo Clinic Arizona
Phoenix Arizona, 85054, United States
University of California, Irvine Medical Center (UC Irvine)
Orange California, 92868, United States
Stanford University
Stanford California, 94305, United States
University of Miami
Miami Florida, 33136, United States
University of Chicago Medical Center
Chicago Illinois, 60637, United States
Loyola University Medical Center
Maywood Illinois, 60153, United States
Brigham and Women's Hospital
Boston Massachusetts, 02115, United States
University of Michigan Health System
Ann Arbor Michigan, 48109, United States
University of Minnesota
Minneapolis Minnesota, 55455, United States
Mayo Clinic
Rochester Minnesota, 55905, United States
University of North Carolina
Chapel Hill North Carolina, 27599, United States
Ohio State University Medical Center
Columbus Ohio, 43210, United States
Vanderbilt University Medical Center
Nashville Tennessee, 37232, United States
The University of Texas Health Science Center at San Antonio, Medical Arts & Research Center
San Antonio Texas, 78229, United States
University of Virginia Health Science Center, Department of Urology
Charlottesville Virginia, 22908, United States
Cancer Research and Biostatistics (Data Management and Statistical Office)
Seattle Washington, 98101, United States

How clear is this clinincal trial information?

Study is for people with:

Bladder Cancer

Estimated Enrollment:

350

Study ID:

NCT01157676

Recruitment Status:

Completed

Sponsor:


University of Miami

How clear is this clinincal trial information?

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