Open Vs Robotic-Assisted Radical Cystectomy: A Randomized Trial

Status:	Active, not recruiting
Healthy:	No
Age Range:	18 - Any
Updated:	6/28/2018
Start Date:	July 2011
End Date:	December 2018

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).

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.

We found this trial at

sites

University of Miami

Miami, Florida 33124

(305) 284-2211