Summary

for people ages 18 years and up (full criteria)
at Orange, California and other locations
study started
estimated completion

Description

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).

Keywords

Bladder Cancer Requiring Cystectomyopen cystectomyrobotic assisted radical cystectomybladder cancerUrinary Bladder NeoplasmsQuality of Life QuestionnairesGet up and Go testHand Grip test

Eligibility

You can join if…

Open to people ages 18 years and up

  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).

You CAN'T join if...

  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.

Locations

  • University of California, Irvine Medical Center (UC Irvine)
    OrangeCalifornia92868United States
  • Mayo Clinic Arizona
    PhoenixArizona85054United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of Miami
ID
NCT01157676
Study Type
Interventional
Last Updated