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Open Vs Robotic-Assisted Radical Cystectomy: A Randomized Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01157676
Recruitment Status : Active, not recruiting
First Posted : July 7, 2010
Last Update Posted : June 26, 2018
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Dipen J Parekh, MD, University of Miami

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).

Condition or disease Intervention/treatment Phase
Bladder Cancer Requiring Cystectomy Other: Quality of Life Questionnaires Other: Get up and Go test Other: Hand Grip test Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 350 participants
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
Official Title: Open Vs Robotic-Assisted Radical Cystectomy: A Randomized Trial
Study Start Date : July 2011
Actual Primary Completion Date : December 2017
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Open cystectomy
Standard of care treatment
Other: Quality of Life Questionnaires
Quality of Life Questionnaires

Other: Get up and Go test
Timed Get up and Go test

Other: Hand Grip test
Hand grip strength test

Active Comparator: Robotic assisted radical cystectomy
Standard of care treatment
Other: Quality of Life Questionnaires
Quality of Life Questionnaires

Other: Get up and Go test
Timed Get up and Go test

Other: Hand Grip test
Hand grip strength test

Primary Outcome Measures :
  1. Determine if RARC provides a non inferior oncologic control to open radical cystectomy, as measure by two-year progression free survival. [ Time Frame: 36 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01157676

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

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Dipen J Parekh, MD, Chairman of Urology, University of Miami Identifier: NCT01157676     History of Changes
Other Study ID Numbers: 20120408
R01CA155388 ( U.S. NIH Grant/Contract )
36911 ( Other Identifier: Investigator-Assigned ID )
First Posted: July 7, 2010    Key Record Dates
Last Update Posted: June 26, 2018
Last Verified: June 2018
Keywords provided by Dipen J Parekh, MD, University of Miami:
open cystectomy
robotic assisted radical cystectomy
bladder cancer
Additional relevant MeSH terms:
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Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Urinary Bladder Diseases
Urologic Diseases