CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 350 enrolled
Drug / intervention
Open radical cystectomy +2 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01157676
NCT01157676N/ACompleted

Open Vs Robotic-Assisted Radical Cystectomy: A Randomized Trial

University of Miami·interventional·Posted Jul 7, 2010·Updated Nov 3, 2020

In Brief

A clinical study evaluating Open radical cystectomy, Robotic assisted radical cystectomy, and 1 other intervention for Bladder Cancer Requiring Cystectomy. Completed, enrolled 350 participants across 16 sites.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJul 7, 2010
Enrollment StartJul 1, 2011
Primary CompletionDec 1, 2018
TodayJul 2, 2026
Enrollment to primary: 7.4 yearsPosted 16.0 years ago

Interventions

Open radical cystectomyprocedure

Standard of care removal of urinary bladder.

Robotic assisted radical cystectomyprocedure

Standard of care removal of urinary bladder using DaVinci robot.

DaVinci robotdevice

DaVinci robotic surgical system.