NCT01157676

Open Vs Robotic-Assisted Radical Cystectomy: A Randomized Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 350 (actual)
• Sponsor: University of Miami · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Bladder Cancer Requiring Cystectomy

Interventions

Type	Name	Description
PROCEDURE	Open radical cystectomy	Standard of care removal of urinary bladder.
PROCEDURE	Robotic assisted radical cystectomy	Standard of care removal of urinary bladder using DaVinci robot.
DEVICE	DaVinci robot	DaVinci robotic surgical system.

Timeline

• Start date: 2011-07-01
• Primary completion: 2018-12-01
• Completion: 2018-12-01
• First posted: 2010-07-07
• Last updated: 2020-11-03
• Results posted: 2020-01-13

Locations

16 sites across 1 country: United States