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Open Vs Robotic-Assisted Radical Cystectomy: A Randomized Trial

18 Years
Open (Enrolling)
Bladder Cancer Requiring Cystectomy

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Trial Information

Open Vs Robotic-Assisted Radical Cystectomy: A Randomized Trial

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.

Type of Study:


Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Determine if RARC provides a non inferior oncologic control to open radical cystectomy, as measure by two-year progression free survival.

Outcome Time Frame:

36 months

Safety Issue:


Principal Investigator

Dipen J Parekh, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Miami


United States: Institutional Review Board

Study ID:




Start Date:

March 2009

Completion Date:

August 2016

Related Keywords:

  • Bladder Cancer Requiring Cystectomy
  • open cystectomy
  • robotic assisted radical cystectomy
  • bladder cancer
  • Urinary Bladder Neoplasms



Mayo Clinic Rochester, Minnesota  55905
Loyola University Medical Center Maywood, Illinois  60153
Stanford University Stanford, California  94305
Brigham and Women's Hospital Boston, Massachusetts  02115
Vanderbilt University Medical Center Nashville, Tennessee  37232-2516
University of Minnesota Minneapolis, Minnesota  55455
University of North Carolina Chapel Hill, North Carolina  27599
University of Chicago Medical Center Chicago, Illinois  60637
Ohio State University Medical Center Columbus, Ohio  43210
University of Miami Miami, Florida  33136
Mayo Clinic Arizona Scottsdale, Arizona  85259
University of Michigan Health System Ann Arbor, Michigan  
University of California, Irvine Medical Center (UC Irvine) Orange, California  92868
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