Open Vs Robotic-Assisted Radical Cystectomy: A Randomized Trial
This study is currently recruiting participants.
Verified April 2013 by University of Miami
Sponsor:
University of Miami
Collaborator:
Information provided by (Responsible Party):
Dipen J Parekh, MD, University of Miami
ClinicalTrials.gov Identifier:
NCT01157676
First received: June 30, 2010
Last updated: April 28, 2013
Last verified: April 2013
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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:
- Patient must have biopsy proven bladder cancer. Official pathology report reviewed at the participating institution is required.
- Bladder cancer must be clinical stage T1-T4, N0-1, M0. (AJCC 7th edition) or refractory cis (carcinoma in situ).
Exclusion Criteria:
- Inability to give informed consent.
- Prior major abdominal and pelvic open surgical procedures that would preclude a safe robotic approach, as determined by the treating surgeon.
- 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.
- Age <18 or >99 years.
- Pregnancy.
Contacts and Locations
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: Atreya Dash, MD 714-456-2817 dasha@uci.edu | |
| Contact: Victor Huynh 714-456-8176 vbhuynh@hs.uci.edu | |
| Principal Investigator: Atreya Dash, MD | |
| Stanford University | Recruiting |
| Stanford, California, United States, 94305 | |
| Contact: Mark L Gonzalgo, MD, PhD 650-725-5544 gonzalgo@stanford.edu | |
| Contact: Anna Ramakrishnan, MS 650-736-0697 annarama@stanford.edu | |
| Principal Investigator: Mark Gonzalgo, MD, PhD | |
| United States, Florida | |
| University of Miami | Recruiting |
| Miami, Florida, United States, 33136 | |
| Contact: Dipen Parekh, MD 305-243-6591 parekhd@med.miami.edu | |
| Contact: Murugesan Manoharan, MD 305-243-6090 mmanoharan@med.miami.edu | |
| Principal Investigator: Dipen Parekh, MD | |
| 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: Robert Ward 612-626-6661 rcward@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 | |
| Contact: Raj S Pruthi, MD, FACS 919-966-8217 | |
| 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: Linda Hernandez, RN 210-450-0016 hernandezmh@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: | April 28, 2013 |
| 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 Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site |
Neoplasms Urinary Bladder Diseases Urologic Diseases |
ClinicalTrials.gov processed this record on May 19, 2013