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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

Tracking Information
First Submitted Date  ICMJE June 30, 2010
First Posted Date  ICMJE July 7, 2010
Results First Submitted Date  ICMJE February 11, 2019
Results First Posted Date  ICMJE January 13, 2020
Last Update Posted Date November 3, 2020
Study Start Date  ICMJE July 2011
Actual Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 23, 2019)
  • 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.
  • 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.
  • 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
  • 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.
  • 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.
  • 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.
  • 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.
  • 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
  • Length of Operative Time [ Time Frame: At time of cystectomy, approximately 1 hour ]
    Length of minutes of cystectomy procedure
  • 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)
  • 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.
  • 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.
  • 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.
  • 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.
  • Total Postoperative Analgesic Requirements [ Time Frame: At time of cystectomy, approximately 1 hour ]
    Total postoperative analgesic requirements in milli grams
  • 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).
  • 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.
  • 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.
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: July 5, 2010)
Conduct a prospective, randomized trial to compare time to recovery after open versus robotic assisted radical cystectomy with pelvic lymph node dissection. [ Time Frame: 24 months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 23, 2019)
Cost [ Time Frame: Day 7 ]
Fixed and variable costs associated with the procedure.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Open Vs Robotic-Assisted Radical Cystectomy: A Randomized Trial
Official Title  ICMJE Open Vs Robotic-Assisted Radical Cystectomy: A Randomized Trial
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Bladder Cancer Requiring Cystectomy
Intervention  ICMJE
  • Procedure: Open radical cystectomy
    Standard of care removal of urinary bladder.
  • Procedure: Robotic assisted radical cystectomy
    Standard of care removal of urinary bladder using DaVinci robot.
  • Device: DaVinci robot
    DaVinci robotic surgical system.
Study Arms  ICMJE
  • Active Comparator: Open cystectomy
    Open cystectomy performed using an incision made just above or at the level of umbilicus to the pubic symphysis.
    Intervention: Procedure: Open radical cystectomy
  • Active Comparator: Robotic assisted radical cystectomy
    Robotic assisted Radical Cystectomy (RARC) is accomplished by a robot assisted laparoscopic approach.
    Interventions:
    • Procedure: Robotic assisted radical cystectomy
    • Device: DaVinci robot
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 13, 2015)
350
Original Estimated Enrollment  ICMJE
 (submitted: July 5, 2010)
70
Actual Study Completion Date  ICMJE December 2018
Actual Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01157676
Other Study ID Numbers  ICMJE 20120408
R01CA155388 ( U.S. NIH Grant/Contract )
36911 ( Other Identifier: Investigator-Assigned ID )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Dipen J Parekh, MD, University of Miami
Original Responsible Party Dipen Parekh, MD, the Univesity of Texas Health Science Center at San Antonio
Current Study Sponsor  ICMJE University of Miami
Original Study Sponsor  ICMJE The University of Texas Health Science Center at San Antonio
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Dipen J Parekh, MD University of Miami
PRS Account University of Miami
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP