Open Vs Robotic-Assisted Radical Cystectomy: A Randomized Trial

Completed · Not applicable

Conditions studied: Bladder Cancer Requiring Cystectomy

In brief

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).

Key facts

Study ID

NCT01157676

Run by

University of Miami

People needed

350

Starts

2011-07-01

Expected to finish

2018-12-01

Last updated by the study team

2020-11-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• Mayo Clinic Arizona — Phoenix, Arizona, United States
• University of California, Irvine Medical Center (UC Irvine) — Orange, California, United States
• Stanford University — Stanford, California, United States
• University of Miami — Miami, Florida, United States
• University of Chicago Medical Center — Chicago, Illinois, United States
• Loyola University Medical Center — Maywood, Illinois, United States
• Brigham and Women's Hospital — Boston, Massachusetts, United States
• University of Michigan Health System — Ann Arbor, Michigan, United States
• University of Minnesota — Minneapolis, Minnesota, United States
• Mayo Clinic — Rochester, Minnesota, United States
• University of North Carolina — Chapel Hill, North Carolina, United States
• Ohio State University Medical Center — Columbus, Ohio, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• The University of Texas Health Science Center at San Antonio, Medical Arts & Research Center — San Antonio, Texas, United States
• University of Virginia Health Science Center, Department of Urology — Charlottesville, Virginia, United States
• Cancer Research and Biostatistics (Data Management and Statistical Office) — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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