Open Vs Robotic-Assisted Radical Cystectomy: A Randomized Trial

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by University of Miami
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Dipen J Parekh, MD, University of Miami
ClinicalTrials.gov Identifier:
NCT01157676
First received: June 30, 2010
Last updated: February 8, 2014
Last verified: February 2014
  Purpose

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).


Condition Intervention
Bladder Cancer Requiring Cystectomy
Other: Quality of Life Questionnaires
Other: Get up and Go test
Other: Hand Grip test

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Open Vs Robotic-Assisted Radical Cystectomy: A Randomized Trial

Resource links provided by NLM:


Further study details as provided by University of Miami:

Primary Outcome Measures:
  • Determine if RARC provides a non inferior oncologic control to open radical cystectomy, as measure by two-year progression free survival. [ Time Frame: 36 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 320
Study Start Date: March 2009
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Open cystectomy
Standard of care treatment
Other: Quality of Life Questionnaires
Quality of Life Questionnaires
Other: Get up and Go test
Timed Get up and Go test
Other: Hand Grip test
Hand grip strength test
Robotic assisted radical cystectomy
Standard of care treatment
Other: Quality of Life Questionnaires
Quality of Life Questionnaires
Other: Get up and Go test
Timed Get up and Go test
Other: Hand Grip test
Hand grip strength test

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Bladder cancer patients who are a candidate for radical cystectomy.

Criteria

Inclusion Criteria:

  1. Patient must have biopsy proven bladder cancer. Official pathology report reviewed at the participating institution is required.
  2. Bladder cancer must be clinical stage T1-T4, N0-1, M0. (AJCC 7th edition) or refractory cis (carcinoma in situ).

Exclusion Criteria:

  1. Inability to give informed consent.
  2. Prior major abdominal and pelvic open surgical procedures that would preclude a safe robotic approach, as determined by the treating surgeon.
  3. At the discretion of the treating surgeon, any pre-existing condition such as severe chronic obstructive pulmonary disease that precludes a safe initiation or maintenance of pneumoperitoneum over a prolonged period of time and during surgery.
  4. Age <18 or >99 years.
  5. Pregnancy.
  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: NCT01157676

Contacts
Contact: Dipen J Parekh, MD (305) 243-6591 parekhd@med.miami.edu
Contact: Murugesan Manoharan, MD (305) 243-6090 mmanoharan@med.miami.edu

Locations
United States, Arizona
Mayo Clinic Arizona Recruiting
Phoenix, Arizona, United States, 85054
Contact: Laurie Mihalik    480-342-3256    mihalik.laurie@mayo.edu   
Principal Investigator: Eric Castle, MD         
United States, California
University of California, Irvine Medical Center (UC Irvine) Recruiting
Orange, California, United States, 92868
Contact: Victor Huynh    714-456-8176    vbhuynh@hs.uci.edu   
Contact: Atreya Dash, MD       atreya@uw.edu   
Principal Investigator: Edward Uchio, MD         
Stanford University Recruiting
Stanford, California, United States, 94305
Contact: Ida Bezabeh    650-725-8057    ibezabeh@stanford.edu   
Principal Investigator: Eila Skinner, MD         
United States, Florida
University of Miami Recruiting
Miami, Florida, United States, 33136
Contact: Mark Gonzalgo, MD, PhD    305-243-6591    m.gonzalgo@med.miami.edu   
Contact: Dipen Parekh, MD    305 243 6591    parekhd@med.miami.edu   
Principal Investigator: Mark Gonzalgo, MD, PhD         
United States, Illinois
University of Chicago Medical Center Recruiting
Chicago, Illinois, United States, 60637
Contact: Natali Rutiaga    773-702-4653    nrutiaga@medicine.bsd.uchicago.edu   
Principal Investigator: Norm Smith, MD         
Loyola University Medical Center Recruiting
Maywood, Illinois, United States, 60153
Contact: Marcus L Quek, MD    708-216-5098    mquek@lumc.edu   
Contact: Mary Beth Bartolotta, RN, BSN    708-327-2237    mbartolotta@lumc.edu   
Principal Investigator: Marcus Quek, MD         
United States, Massachusetts
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Adam Kibel, MD    617-732-6325    akibel@partners.org   
Contact: Michael Meyers    617-732-8958    mmeyers@pchi.partners.org   
Principal Investigator: Adam Kibel, MD         
United States, Michigan
University of Michigan Health System Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Alon Z Weizer, MD    734-615-8829    aweizer@med.umich.edu   
Contact: Jean E Humrich, CCRP    734-232-4862    jeo@med.umich.edu   
Principal Investigator: Alon Weizer, MD         
United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Badrinath Konety, MD    612-624-7792    brkonety@umn.edu   
Contact: Therese Perrier    612-624-7794    perri084@umn.edu   
Principal Investigator: Badrinath Konety, MD         
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Matthew Tollefson, MD    507-266-4319    tollefson.matthew@mayo.edu   
Contact: Steven Boorijian, MD    507-284-3982    boorjian.stephen@mayo.edu   
Principal Investigator: Matthew K. Tollefson, MD         
United States, North Carolina
University of North Carolina Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Michael Woods, MD    919-966-8217    michael_woods@med.unc.edu   
Principal Investigator: Michael Woods, MD         
United States, Ohio
Ohio State University Medical Center Recruiting
Columbus, Ohio, United States, 43210
Contact: Ahmad Sabsigh, MD    614-366-8560    ahmad.shabsigh@osumc.edu   
Contact: David Sharp, MD    614-366-7389    David.Sharp2@osumc.edu   
Principal Investigator: Ahmad Sabsigh, MD         
United States, Tennessee
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37232
Contact: Pamela Steele, RN    615-343-2120    pamela.steele@vanderbilt.edu   
Contact: Brenda Hughes, RN    615-343-0445    brenda.hughes@vanderbilt.edu   
Principal Investigator: Daniel Barocas, MD         
United States, Texas
The University of Texas Health Science Center at San Antonio, Medical Arts & Research Center Recruiting
San Antonio, Texas, United States, 78229
Contact: Robert Svatek, MD    210-567-5676    svatek@uthscsa.edu   
Principal Investigator: Robert Svatek, MD         
United States, Virginia
University of Virginia Health Science Center, Department of Urology Recruiting
Charlottesville, Virginia, United States, 22908
Contact: Patricia Battle, LPN, CRC    434-924-5649    pya@virginia.edu   
Contact: Elaine Woodson    434-982-3704    mew3u@virginia.edu   
Principal Investigator: Tracey Krupski, MD         
United States, Washington
Cancer Research and Biostatistics (Data Management and Statistical Office) Not yet recruiting
Seattle, Washington, United States, 98101
Contact: Vicki Green    206-652-4252    vickig@crab.org   
Contact: John J Crowley, PhD    206-839-1738    johnc@crab.org   
Sponsors and Collaborators
University of Miami
Investigators
Principal Investigator: Dipen J Parekh, MD University of Miami
  More Information

No publications provided

Responsible Party: Dipen J Parekh, MD, Chairman of Urology, University of Miami
ClinicalTrials.gov Identifier: NCT01157676     History of Changes
Other Study ID Numbers: 36911, R01CA155388
Study First Received: June 30, 2010
Last Updated: February 8, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Miami:
open cystectomy
robotic assisted radical cystectomy
bladder cancer

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

ClinicalTrials.gov processed this record on October 20, 2014