Randomized Trial Comparing Robotic and Open Radical Cystectomy

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT01076387
First received: February 24, 2010
Last updated: May 19, 2014
Last verified: May 2014
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To examine clinical and pathological outcomes of robotic-assisted radical cystectomy and open radical cystectomy. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Intra-operative performance (surgical time, blood loss) [ Time Frame: time from anesthesia induction to final skin closure ] [ Designated as safety issue: No ]
  • Pathologic findings, including the stage specific, soft tissue surgical margin rate and number of lymph nodes removed. [ Time Frame: 1.5 years ] [ Designated as safety issue: No ]
  • Bladder cancer recurrence (local, upper tract and distant disease) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • complications grade 2-5 [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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
Study Start Date: February 2010
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: February 2015 (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

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

Responsible Party: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT01076387     History of Changes
Other Study ID Numbers: 10-016
Study First Received: February 24, 2010
Last Updated: May 19, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on July 22, 2014