Overview

This trial is active, not recruiting.

Condition bladder cancer requiring cystectomy
Treatments quality of life questionnaires, get up and go test, hand grip test
Sponsor University of Miami
Collaborator National Cancer Institute (NCI)
Start date March 2009
End date November 2017
Trial size 350 participants
Trial identifier NCT01157676, 20120408, 36911, R01CA155388

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
Standard of care treatment
quality of life questionnaires
Quality of Life Questionnaires
get up and go test
Timed Get up and Go test
hand grip test
Hand grip strength test
Standard of care treatment
quality of life questionnaires
Quality of Life Questionnaires
get up and go test
Timed Get up and Go test
hand grip test
Hand grip strength test

Primary Outcomes

Measure
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

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title Open Vs Robotic-Assisted Radical Cystectomy: A Randomized Trial
Principal investigator Dipen J Parekh, MD
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by University of Miami.