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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
350
Standard of care removal of urinary bladder.
Standard of care removal of urinary bladder using DaVinci robot.
DaVinci robotic surgical system.
Mayo Clinic Arizona
Phoenix, Arizona, United States
University of California, Irvine Medical Center (UC Irvine)
Orange, California, United States
Stanford University
Stanford, California, United States
University of Miami
Miami, Florida, United States
University of Chicago Medical Center
Chicago, Illinois, United States
Loyola University Medical Center
Maywood, Illinois, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
University of Michigan Health System
Ann Arbor, Michigan, United States
University of Minnesota
Minneapolis, Minnesota, United States
Mayo Clinic
Rochester, Minnesota, United States
...and 6 more locations
Percentage of Participants With 2-year Progression Free Survival (PFS)
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.
Time frame: 24 months
Number of Participants With Positive Margins
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.
Time frame: At time of cystectomy, approximately 1 hour.
Number of Participants Requiring Lymph Node Dissection
Evaluated are the number of participants requiring extended or standard lymph node dissection
Time frame: At time of cystectomy, approximately 1 hour
Quality of Life (QOL) Outcomes
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.
Time frame: at baseline, 3 month, and 6 months
Number of Participants With Post-surgical Complications
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.
Time frame: 90 days post operative
Amount of Estimated Blood Loss (EBL) in ml
Perioperative measures such as EBL will be evaluated by measuring the amount of participant blood loss in ml.
Time frame: At time of cystectomy, approximately 1 hour
Number of Participants Requiring Blood Transfusion
Number of participants requiring peri, intra, and post operative blood transfusion.
Time frame: At time of cystectomy, approximately 1 hour
Number of Days of Post Operative Length of Hospital Stay
Number of days of post operative length of hospital stay will be evaluated
Time frame: Day 10 post surgery
Length of Operative Time
Length of minutes of cystectomy procedure
Time frame: At time of cystectomy, approximately 1 hour
Laboratory Values
Serum Hemoglobin (Hb) and Albumin will be reported in grams per deciliters (g/dL)
Time frame: baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months, 36 months
Measures of Functional Independence as Assessed by the Activities of Daily Living (ADL) Questionnaire
Participant reported ADL questionnaire is a 7 item questionnaire with scores ranging from 7-21 with a lower score indicating increased independence.
Time frame: baseline, 1 month , 3 months, 6 months
Percentage of Participants With 3-year Progression Free Survival (PFS)
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.
Time frame: 3 years
Quality of Life (QOL) Outcomes as Assessed by the Short Form 8 (SF-8) Questionnaire
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.
Time frame: baseline, 3 month, and 6 month
Total Number of Participants Requiring Intra-operative Fluid Requirement
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.
Time frame: At time of cystectomy, approximately 1 hour
Total Postoperative Analgesic Requirements
Total postoperative analgesic requirements in milli grams
Time frame: At time of cystectomy, approximately 1 hour
Creatinine Value.
Serum creatinine will be reported in milligrams per deciliters (mg/dL).
Time frame: baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months, 36 months
Measures of Functional Independence as Assessed by the Instrumental Activities of Daily Living (IADL) Questionnaire
Participant reported IADL questionnaire is an 8 item questionnaire with scores ranging from 8-32 with a lower score indicating increased independence.
Time frame: baseline, 1 month, 3 months, 6 months
Performance Related Measures of Functional Independence as Assessed by the Hand Grip Strength Test
The hand grip strength test is measured in kilograms of pressure using a handheld dynamometer.
Time frame: baseline, 1 month, 3 months, 6 months
Performance Related Measures of Functional Independence as Assessed by the Time Up and Go (TUG) Walking Test
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.
Time frame: baseline, 1 month, 3 months, 6 months
Quality of Life (QOL) Outcomes as Assessed by the Functional Assessment of Cancer Therapy - Vanderbilt Cystectomy Index (FACT-VCI) Questionnaire
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.
Time frame: baseline, 3 months, 6 months
Cost
Fixed and variable costs associated with the procedure.
Time frame: Day 7
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