Randomized Trial Comparing Robotic and Open Radical Cystectomy

March 12, 2020 updated by: Memorial Sloan Kettering Cancer Center

A Prospective, Randomized Trial Comparing Robotic and Open Radical Cystectomy

The purpose of this study is to determine if using robotic surgical technology during bladder cancer surgery helps to reduce complications during and after the surgery. The removal of the bladder and lymph nodes will be done by a robotic or by an open technique. It may be a Robotic-assisted Radical Cystectomy (RARC) and Pelvic Lymph Node Dissection. Or it may be an Open Radical Cystectomy (ORC) and Pelvic Lymph Node Dissection.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

124

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age > 18 years.
  • Scheduled for radical cystectomy at MSKCC

Exclusion Criteria:

  • Prior pelvic or abdominal radiation therapy;
  • Prior extensive open abdominal surgery, defined by the discretion of the attending surgeon
  • Any clinical contraindication for Trendelenburg positioning

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: open radical cystectomy
This is a prospective, randomized study designed to compare two techniques of radical cystectomy with PLND (open and robotic) for bladder cancer.
Procedure: open radical cystectomy
Open radical cystectomy, pelvic lymph node dissection and open urinary diversion.
Active Comparator: robotic-assisted radical cystectomy
This is a prospective, randomized study designed to compare two techniques of radical cystectomy with PLND (open and robotic) for bladder cancer.
Procedure: robotic-assisted radical cystectomy
Robotic radical cystectomy, pelvic lymph node dissection and open urinary diversion. Robotic radical cystectomy is routinely performed by robotically trained and experienced minimally invasive surgeons.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To compare surgical complications of robotic-assisted radical cystectomy and open radical cystectomy.
Time Frame: intraoperative and 90-day postoperative period
intraoperative and 90-day postoperative period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To examine clinical and pathological outcomes of robotic-assisted radical cystectomy and open radical cystectomy.
Time Frame: 2 years
2 years
Intra-operative performance (surgical time, blood loss)
Time Frame: time from anesthesia induction to final skin closure
time from anesthesia induction to final skin closure
Pathologic findings, including the stage specific, soft tissue surgical margin rate and number of lymph nodes removed.
Time Frame: 1.5 years
1.5 years
Bladder cancer recurrence (local, upper tract and distant disease)
Time Frame: 2 years
2 years
complications grade 2-5
Time Frame: 2 years
A secondary analysis will be used to determine if the total burden of grade 2-5 complications in the robotic arm is different from the open arm.
2 years
complication grade 3-5
Time Frame: 2 years
Determine if there is a difference in either the number of patients with grade 3-5 complication or the total number of grade 3-5 complication in the two arms of the study.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memorial Sloan Kettering Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2010

Primary Completion (Actual)

March 12, 2020

Study Completion (Actual)

March 12, 2020

Study Registration Dates

First Submitted

February 24, 2010

First Submitted That Met QC Criteria

February 24, 2010

First Posted (Estimate)

February 26, 2010

Study Record Updates

Last Update Posted (Actual)

March 16, 2020

Last Update Submitted That Met QC Criteria

March 12, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10-016

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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