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Open Vs Robotic-Assisted Radical Cystectomy: A Randomized Trial

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ClinicalTrials.gov Identifier: NCT01157676
Recruitment Status : Completed
First Posted : July 7, 2010
Results First Posted : January 13, 2020
Last Update Posted : November 3, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Dipen J Parekh, MD, University of Miami

Brief Summary:
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 or disease Intervention/treatment Phase
Bladder Cancer Requiring Cystectomy Procedure: Open radical cystectomy Procedure: Robotic assisted radical cystectomy Device: DaVinci robot Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 350 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Non inferiority phase 3 randomized clinical trial comparing robotic to open radical cystectomy
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open Vs Robotic-Assisted Radical Cystectomy: A Randomized Trial
Study Start Date : July 2011
Actual Primary Completion Date : December 2018
Actual Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Open cystectomy
Open cystectomy performed using an incision made just above or at the level of umbilicus to the pubic symphysis.
Procedure: Open radical cystectomy
Standard of care removal of urinary bladder.

Active Comparator: Robotic assisted radical cystectomy
Robotic assisted Radical Cystectomy (RARC) is accomplished by a robot assisted laparoscopic approach.
Procedure: Robotic assisted radical cystectomy
Standard of care removal of urinary bladder using DaVinci robot.

Device: DaVinci robot
DaVinci robotic surgical system.




Primary Outcome Measures :
  1. Percentage of Participants With 2-year Progression Free Survival (PFS) [ Time Frame: 24 months ]
    Progression will be determined by the treating physician using the Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 criteria based on radiographic or pathological evidence of disease progression or death from disease.

  2. Number of Participants With Positive Margins [ Time Frame: At time of cystectomy, approximately 1 hour. ]
    Evaluated are the number of participants with positive surgical, bladder, and urethral margins. Positive margin is defined as presence of tumor cells at the edge of the dissected tissue.

  3. Number of Participants Requiring Lymph Node Dissection [ Time Frame: At time of cystectomy, approximately 1 hour ]
    Evaluated are the number of participants requiring extended or standard lymph node dissection

  4. Quality of Life (QOL) Outcomes [ Time Frame: at baseline, 3 month, and 6 months ]
    Functional Assessment of Cancer Therapy- Vanderbilt Cystectomy Index (FACT-VCI) scores range is 0-168 which is sum of physical, emotional, wellbeing, and FACTS Bl Cys. higher scores=better QOL.

  5. Number of Participants With Post-surgical Complications [ Time Frame: 90 days post operative ]
    Post surgical complications will be evaluated using the Clavien grading system with scores ranging from 0-5 with the higher number indicating increased post-surgical complications.

  6. Amount of Estimated Blood Loss (EBL) in ml [ Time Frame: At time of cystectomy, approximately 1 hour ]
    Perioperative measures such as EBL will be evaluated by measuring the amount of participant blood loss in ml.

  7. Number of Participants Requiring Blood Transfusion [ Time Frame: At time of cystectomy, approximately 1 hour ]
    Number of participants requiring peri, intra, and post operative blood transfusion.

  8. Number of Days of Post Operative Length of Hospital Stay [ Time Frame: Day 10 post surgery ]
    Number of days of post operative length of hospital stay will be evaluated

  9. Length of Operative Time [ Time Frame: At time of cystectomy, approximately 1 hour ]
    Length of minutes of cystectomy procedure

  10. Laboratory Values [ Time Frame: baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months, 36 months ]
    Serum Hemoglobin (Hb) and Albumin will be reported in grams per deciliters (g/dL)

  11. Measures of Functional Independence as Assessed by the Activities of Daily Living (ADL) Questionnaire [ Time Frame: baseline, 1 month , 3 months, 6 months ]
    Participant reported ADL questionnaire is a 7 item questionnaire with scores ranging from 7-21 with a lower score indicating increased independence.

  12. Percentage of Participants With 3-year Progression Free Survival (PFS) [ Time Frame: 3 years ]
    Progression will be determined by the treating physician using the RECIST Version 1.1 criteria based on radiographic or pathological evidence of disease progression or death from disease.

  13. Quality of Life (QOL) Outcomes as Assessed by the Short Form 8 (SF-8) Questionnaire [ Time Frame: baseline, 3 month, and 6 month ]
    The SF-8 consists of two component summary scores; physical (PCS) and mental component summary (MCS). They are scored by weighting each score to a norm-based scoring model. The total scores will be reported as a percentile with higher score indicating better quality of health.

  14. Total Number of Participants Requiring Intra-operative Fluid Requirement [ Time Frame: At time of cystectomy, approximately 1 hour ]
    Total number of participants requiring Intra-operative fluid requirement. (blood+plasma+platelets) Note: In robotic group 1 participant received both plasma and platelets and 1 other received platelets in addition to blood transfusion. In the open group 5 participants received plasma in addition to blood transfusion.

  15. Total Postoperative Analgesic Requirements [ Time Frame: At time of cystectomy, approximately 1 hour ]
    Total postoperative analgesic requirements in milli grams

  16. Creatinine Value. [ Time Frame: baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months, 36 months ]
    Serum creatinine will be reported in milligrams per deciliters (mg/dL).

  17. Measures of Functional Independence as Assessed by the Instrumental Activities of Daily Living (IADL) Questionnaire [ Time Frame: baseline, 1 month, 3 months, 6 months ]
    Participant reported IADL questionnaire is an 8 item questionnaire with scores ranging from 8-32 with a lower score indicating increased independence.

  18. Performance Related Measures of Functional Independence as Assessed by the Hand Grip Strength Test [ Time Frame: baseline, 1 month, 3 months, 6 months ]
    The hand grip strength test is measured in kilograms of pressure using a handheld dynamometer.

  19. Performance Related Measures of Functional Independence as Assessed by the Time Up and Go (TUG) Walking Test [ Time Frame: baseline, 1 month, 3 months, 6 months ]
    The TUG test is measured in seconds. Patients will be timed as they rise from a standard chair, walk 3 meters, turn, walk back, and sit again.

  20. Quality of Life (QOL) Outcomes as Assessed by the Functional Assessment of Cancer Therapy - Vanderbilt Cystectomy Index (FACT-VCI) Questionnaire [ Time Frame: baseline, 3 months, 6 months ]
    FACT-VCI consists of eight domains: Five subscale scores (physical wellbeing, social wellbeing, emotional wellbeing, functional wellbeing, and FACT for patients with Bladder Cancer following Cystectomy [FACT-BL-Cys]) and three derived scores (trial outcome index), FACT-General form (FACT-G), and FACT-BL-Cys Total.The ranges of scores for each domain are as follows: 0-28 for physical, social, and functional wellbeing; 0-24 for emotional wellbeing; 0-60 for FACT-BL-Cys; 0-116 for FACT-VCI Trial Outcome Index (sum of physical wellbeing, functional wellbeing, and FACT-BL-Cys scores); 0-108 for FACT-G (sum of physical, social, emotional, and functional wellbeing scores); and 0-168 for FACT-BL-Cys Total (sum of physical, social, emotional, and functional wellbeing scores, and FACT-BL-Cys).The higher score indicates increased wellbeing.


Secondary Outcome Measures :
  1. Cost [ Time Frame: Day 7 ]
    Fixed and variable costs associated with the procedure.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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): NCT01157676


Locations
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United States, Arizona
Mayo Clinic Arizona
Phoenix, Arizona, United States, 85054
United States, California
University of California, Irvine Medical Center (UC Irvine)
Orange, California, United States, 92868
Stanford University
Stanford, California, United States, 94305
United States, Florida
University of Miami
Miami, Florida, United States, 33136
United States, Illinois
University of Chicago Medical Center
Chicago, Illinois, United States, 60637
Loyola University Medical Center
Maywood, Illinois, United States, 60153
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
United States, Michigan
University of Michigan Health System
Ann Arbor, Michigan, United States, 48109
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, North Carolina
University of North Carolina
Chapel Hill, North Carolina, United States, 27599
United States, Ohio
Ohio State University Medical Center
Columbus, Ohio, United States, 43210
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
United States, Texas
The University of Texas Health Science Center at San Antonio, Medical Arts & Research Center
San Antonio, Texas, United States, 78229
United States, Virginia
University of Virginia Health Science Center, Department of Urology
Charlottesville, Virginia, United States, 22908
United States, Washington
Cancer Research and Biostatistics (Data Management and Statistical Office)
Seattle, Washington, United States, 98101
Sponsors and Collaborators
University of Miami
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Dipen J Parekh, MD University of Miami
  Study Documents (Full-Text)

Documents provided by Dipen J Parekh, MD, University of Miami:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dipen J Parekh, MD, Chairman of Urology, University of Miami
ClinicalTrials.gov Identifier: NCT01157676    
Other Study ID Numbers: 20120408
R01CA155388 ( U.S. NIH Grant/Contract )
36911 ( Other Identifier: Investigator-Assigned ID )
First Posted: July 7, 2010    Key Record Dates
Results First Posted: January 13, 2020
Last Update Posted: November 3, 2020
Last Verified: October 2020
Keywords provided by Dipen J Parekh, MD, University of Miami:
open cystectomy
robotic assisted radical cystectomy
bladder cancer
Additional relevant MeSH terms:
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Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases