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Randomized Trial Comparing Robotic and Open Radical Cystectomy

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01076387
First Posted: February 26, 2010
Last Update Posted: March 3, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center
  Purpose
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.

Condition Intervention Phase
Bladder Cancer Procedure: open radical cystectomy Procedure: robotic-assisted radical cystectomy Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Randomized Trial Comparing Robotic and Open Radical Cystectomy

Resource links provided by NLM:


Further study details as provided by Memorial Sloan Kettering Cancer Center:

Primary Outcome Measures:
  • To compare surgical complications of robotic-assisted radical cystectomy and open radical cystectomy. [ Time Frame: intraoperative and 90-day postoperative period ]

Secondary Outcome Measures:
  • To examine clinical and pathological outcomes of robotic-assisted radical cystectomy and open radical cystectomy. [ Time Frame: 2 years ]
  • Intra-operative performance (surgical time, blood loss) [ Time Frame: 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 ]
  • Bladder cancer recurrence (local, upper tract and distant disease) [ Time Frame: 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.

  • 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.


Enrollment: 124
Actual Study Start Date: February 2010
Estimated Study Completion Date: February 2018
Estimated Primary Completion Date: February 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01076387


Locations
United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Investigators
Principal Investigator: Vincent Laudone, MD Memorial Sloan Kettering Cancer Center
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT01076387     History of Changes
Other Study ID Numbers: 10-016
First Submitted: February 24, 2010
First Posted: February 26, 2010
Last Update Posted: March 3, 2017
Last Verified: March 2017

Keywords provided by Memorial Sloan Kettering Cancer Center:
Bladder
Cystectomy
Robotic
Open Radical
10-016

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases


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