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).
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Percentage of Participants With 2-year Progression Free Survival (PFS)
Timeframe: 24 months
Number of Participants With Positive Margins
Timeframe: At time of cystectomy, approximately 1 hour.
Number of Participants Requiring Lymph Node Dissection
Timeframe: At time of cystectomy, approximately 1 hour
Quality of Life (QOL) Outcomes
Timeframe: at baseline, 3 month, and 6 months
Number of Participants With Post-surgical Complications
Timeframe: 90 days post operative
Amount of Estimated Blood Loss (EBL) in ml
Timeframe: At time of cystectomy, approximately 1 hour
Number of Participants Requiring Blood Transfusion
Timeframe: At time of cystectomy, approximately 1 hour
Number of Days of Post Operative Length of Hospital Stay
Timeframe: Day 10 post surgery
Length of Operative Time
Timeframe: At time of cystectomy, approximately 1 hour
Laboratory Values
Timeframe: 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
Timeframe: baseline, 1 month , 3 months, 6 months
Percentage of Participants With 3-year Progression Free Survival (PFS)
Timeframe: 3 years
Quality of Life (QOL) Outcomes as Assessed by the Short Form 8 (SF-8) Questionnaire
Timeframe: baseline, 3 month, and 6 month
Total Number of Participants Requiring Intra-operative Fluid Requirement
Timeframe: At time of cystectomy, approximately 1 hour
Total Postoperative Analgesic Requirements
Timeframe: At time of cystectomy, approximately 1 hour
Creatinine Value.
Timeframe: 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
Timeframe: baseline, 1 month, 3 months, 6 months
Performance Related Measures of Functional Independence as Assessed by the Hand Grip Strength Test
Timeframe: baseline, 1 month, 3 months, 6 months
Performance Related Measures of Functional Independence as Assessed by the Time Up and Go (TUG) Walking Test
Timeframe: 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
Timeframe: baseline, 3 months, 6 months