Status:
COMPLETED
Open Vs Robotic-Assisted Radical Cystectomy: A Randomized Trial
Lead Sponsor:
University of Miami
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Bladder Cancer Requiring Cystectomy
Eligibility:
All Genders
18+ years
Phase:
NA
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 o...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2018
Estimated Enrollment :
350 Patients enrolled
Trial Details
Trial ID
NCT01157676
Start Date
July 1 2011
End Date
December 1 2018
Last Update
November 3 2020
Active Locations (16)
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1
Mayo Clinic Arizona
Phoenix, Arizona, United States, 85054
2
University of California, Irvine Medical Center (UC Irvine)
Orange, California, United States, 92868
3
Stanford University
Stanford, California, United States, 94305
4
University of Miami
Miami, Florida, United States, 33136