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Open Vs Robotic-Assisted Radical Cystectomy: A Randomized Trial

NCT01157676 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 350

Last updated 2020-11-03

Study results available
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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

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.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • University of Miami

    lead OTHER

Principal Investigators

  • Dipen J Parekh, MD · University of Miami

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-07-31
Primary Completion
2018-12-31
Completion
2018-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01157676 on ClinicalTrials.gov