Bladder Cancer Requiring Cystectomy
Conditions
Keywords
open cystectomy, robotic assisted radical cystectomy, bladder cancer
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).
Interventions
PROCEDUREOpen radical cystectomy
Standard of care removal of urinary bladder.
PROCEDURERobotic assisted radical cystectomy
Standard of care removal of urinary bladder using DaVinci robot.
DEVICEDaVinci robot
DaVinci robotic surgical system.
Sponsors
National Cancer Institute (NCI)
University of Miami
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Non inferiority phase 3 randomized clinical trial comparing robotic to open radical cystectomy
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life (QOL) Outcomes as Assessed by the Functional Assessment of Cancer Therapy - Vanderbilt Cystectomy Index (FACT-VCI) Questionnaire | 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. |
| Percentage of Participants With 2-year Progression Free Survival (PFS) | 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 | 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 | 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 | 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 | 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 | 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 | 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 | Day 10 post surgery | Number of days of post operative length of hospital stay will be evaluated |
| Length of Operative Time | At time of cystectomy, approximately 1 hour | Length of minutes of cystectomy procedure |
| Laboratory Values | 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 | 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) | 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 | 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 | 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 | At time of cystectomy, approximately 1 hour | Total postoperative analgesic requirements in milli grams |
| Creatinine Value. | 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 | 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 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cost | Day 7 | Fixed and variable costs associated with the procedure. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Open Cystectomy Standard of care treatment, open cystectomy | 152 |
| Robotic Assisted Radical Cystectomy Standard of care treatment, robotic assisted radical cystectomy | 150 |
| Total | 302 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Randomization | Death | 1 | 1 |
| Randomization | Physician Decision | 1 | 0 |
| Randomization | unresectable | 2 | 3 |
| Randomization | Withdrawal by Subject | 17 | 13 |
| Surgery | converted to open procedure | 0 | 5 |
| Surgery | underwent open cystectomy | 0 | 4 |
| Surgery | underwent robotic cystectomy | 1 | 0 |
Baseline characteristics
| Characteristic | Robotic Assisted Radical Cystectomy | Total | Open Cystectomy |
|---|---|---|---|
| Age, Continuous | 70 years | 68 years | 67 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 12 Participants | 23 Participants | 11 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 135 Participants | 273 Participants | 138 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 3 Participants | 6 Participants | 3 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 4 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 10 Participants | 16 Participants | 6 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 5 Participants | 2 Participants |
| Race (NIH/OMB) White | 133 Participants | 275 Participants | 142 Participants |
| Sex: Female, Male Female | 24 Participants | 48 Participants | 24 Participants |
| Sex: Female, Male Male | 126 Participants | 254 Participants | 128 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 152 | 0 / 150 |
| other Total, other adverse events | 105 / 152 | 101 / 150 |
| serious Total, serious adverse events | 0 / 152 | 0 / 150 |
Outcome results
Primary
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
Population: EBL data was not available on 3 of the open radical cystectomy and 2 of the RARC participants.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Open Radical Cystectomy | Amount of Estimated Blood Loss (EBL) in ml | 700 ml |
| Robotic Assisted Radical Cystectomy | Amount of Estimated Blood Loss (EBL) in ml | 300 ml |
Primary
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
Population: Number of participants included was based on the data available at specific time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Open Radical Cystectomy | Creatinine Value. | Baseline | 1.17 mg/dL | Standard Deviation 0.52 |
| Open Radical Cystectomy | Creatinine Value. | 6-months | 1.21 mg/dL | Standard Deviation 0.46 |
| Open Radical Cystectomy | Creatinine Value. | 24-months | 1.26 mg/dL | Standard Deviation 0.48 |
| Open Radical Cystectomy | Creatinine Value. | 12-months | 1.19 mg/dL | Standard Deviation 0.43 |
| Open Radical Cystectomy | Creatinine Value. | 6-weeks | 1.27 mg/dL | Standard Deviation 0.67 |
| Open Radical Cystectomy | Creatinine Value. | 36-months | 1.26 mg/dL | Standard Deviation 0.53 |
| Open Radical Cystectomy | Creatinine Value. | 3-months | 1.16 mg/dL | Standard Deviation 0.44 |
| Robotic Assisted Radical Cystectomy | Creatinine Value. | 36-months | 1.21 mg/dL | Standard Deviation 0.71 |
| Robotic Assisted Radical Cystectomy | Creatinine Value. | 12-months | 1.25 mg/dL | Standard Deviation 0.58 |
| Robotic Assisted Radical Cystectomy | Creatinine Value. | Baseline | 1.12 mg/dL | Standard Deviation 0.5 |
| Robotic Assisted Radical Cystectomy | Creatinine Value. | 3-months | 1.26 mg/dL | Standard Deviation 0.71 |
| Robotic Assisted Radical Cystectomy | Creatinine Value. | 6-months | 1.28 mg/dL | Standard Deviation 0.57 |
| Robotic Assisted Radical Cystectomy | Creatinine Value. | 24-months | 1.25 mg/dL | Standard Deviation 0.62 |
| Robotic Assisted Radical Cystectomy | Creatinine Value. | 6-weeks | 1.28 mg/dL | Standard Deviation 0.66 |
Primary
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
Population: Number of participants included was based on the data available at specific time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Open Radical Cystectomy | Laboratory Values | Baseline (Hb) | 12.84 g/dL | Standard Deviation 1.87 |
| Open Radical Cystectomy | Laboratory Values | 6-weeks (Hb) | 11.19 g/dL | Standard Deviation 1.58 |
| Open Radical Cystectomy | Laboratory Values | 3-months (Hb) | 12.05 g/dL | Standard Deviation 1.81 |
| Open Radical Cystectomy | Laboratory Values | 6-months (Hb) | 12.73 g/dL | Standard Deviation 2.06 |
| Open Radical Cystectomy | Laboratory Values | 12-months (Hb) | 12.95 g/dL | Standard Deviation 2.48 |
| Open Radical Cystectomy | Laboratory Values | 24-months (Hb) | 13.47 g/dL | Standard Deviation 1.89 |
| Open Radical Cystectomy | Laboratory Values | 36-months (Hb) | 14.14 g/dL | Standard Deviation 1.52 |
| Open Radical Cystectomy | Laboratory Values | Baseline (Albumin) | 3.97 g/dL | Standard Deviation 0.71 |
| Open Radical Cystectomy | Laboratory Values | 6-weeks (Albumin) | 3.66 g/dL | Standard Deviation 0.62 |
| Open Radical Cystectomy | Laboratory Values | 3-months (Albumin) | 3.88 g/dL | Standard Deviation 0.59 |
| Open Radical Cystectomy | Laboratory Values | 6-months (Albumin) | 4.02 g/dL | Standard Deviation 0.43 |
| Open Radical Cystectomy | Laboratory Values | 12-months (Albumin) | 3.96 g/dL | Standard Deviation 0.93 |
| Open Radical Cystectomy | Laboratory Values | 24-months (Albumin) | 4.00 g/dL | Standard Deviation 0.46 |
| Open Radical Cystectomy | Laboratory Values | 36-months (Albumin) | 4.00 g/dL | Standard Deviation 0.44 |
| Robotic Assisted Radical Cystectomy | Laboratory Values | 6-months (Albumin) | 4.04 g/dL | Standard Deviation 0.4 |
| Robotic Assisted Radical Cystectomy | Laboratory Values | Baseline (Hb) | 13.11 g/dL | Standard Deviation 1.84 |
| Robotic Assisted Radical Cystectomy | Laboratory Values | Baseline (Albumin) | 4.00 g/dL | Standard Deviation 0.55 |
| Robotic Assisted Radical Cystectomy | Laboratory Values | 6-weeks (Hb) | 11.62 g/dL | Standard Deviation 1.72 |
| Robotic Assisted Radical Cystectomy | Laboratory Values | 24-months (Albumin) | 3.91 g/dL | Standard Deviation 0.75 |
| Robotic Assisted Radical Cystectomy | Laboratory Values | 3-months (Hb) | 12.17 g/dL | Standard Deviation 2.06 |
| Robotic Assisted Radical Cystectomy | Laboratory Values | 6-weeks (Albumin) | 3.70 g/dL | Standard Deviation 0.62 |
| Robotic Assisted Radical Cystectomy | Laboratory Values | 6-months (Hb) | 12.54 g/dL | Standard Deviation 1.89 |
| Robotic Assisted Radical Cystectomy | Laboratory Values | 12-months (Albumin) | 4.04 g/dL | Standard Deviation 0.46 |
| Robotic Assisted Radical Cystectomy | Laboratory Values | 12-months (Hb) | 13.25 g/dL | Standard Deviation 2.11 |
| Robotic Assisted Radical Cystectomy | Laboratory Values | 3-months (Albumin) | 3.92 g/dL | Standard Deviation 0.6 |
| Robotic Assisted Radical Cystectomy | Laboratory Values | 24-months (Hb) | 13.65 g/dL | Standard Deviation 2.03 |
| Robotic Assisted Radical Cystectomy | Laboratory Values | 36-months (Albumin) | 3.97 g/dL | Standard Deviation 0.65 |
| Robotic Assisted Radical Cystectomy | Laboratory Values | 36-months (Hb) | 13.64 g/dL | Standard Deviation 2.59 |
Primary
Length of Operative Time
Length of minutes of cystectomy procedure
Time frame: At time of cystectomy, approximately 1 hour
Population: The length of operative time is not available for all participants.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Open Radical Cystectomy | Length of Operative Time | 361 minutes |
| Robotic Assisted Radical Cystectomy | Length of Operative Time | 428 minutes |
Primary
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
Population: Number of participants changes depending on their data availability at different time points.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Open Radical Cystectomy | Measures of Functional Independence as Assessed by the Activities of Daily Living (ADL) Questionnaire | Baseline | 7.2 score on a scale |
| Open Radical Cystectomy | Measures of Functional Independence as Assessed by the Activities of Daily Living (ADL) Questionnaire | 1-month | 7.8 score on a scale |
| Open Radical Cystectomy | Measures of Functional Independence as Assessed by the Activities of Daily Living (ADL) Questionnaire | 3-months | 7.5 score on a scale |
| Open Radical Cystectomy | Measures of Functional Independence as Assessed by the Activities of Daily Living (ADL) Questionnaire | 6-months | 7.1 score on a scale |
| Robotic Assisted Radical Cystectomy | Measures of Functional Independence as Assessed by the Activities of Daily Living (ADL) Questionnaire | 6-months | 7.2 score on a scale |
| Robotic Assisted Radical Cystectomy | Measures of Functional Independence as Assessed by the Activities of Daily Living (ADL) Questionnaire | Baseline | 7.2 score on a scale |
| Robotic Assisted Radical Cystectomy | Measures of Functional Independence as Assessed by the Activities of Daily Living (ADL) Questionnaire | 3-months | 7.3 score on a scale |
| Robotic Assisted Radical Cystectomy | Measures of Functional Independence as Assessed by the Activities of Daily Living (ADL) Questionnaire | 1-month | 7.6 score on a scale |
Primary
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
Population: Number of participants included was based on the data available at specific time points.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Open Radical Cystectomy | Measures of Functional Independence as Assessed by the Instrumental Activities of Daily Living (IADL) Questionnaire | Baseline | 8.8 score on a scale |
| Open Radical Cystectomy | Measures of Functional Independence as Assessed by the Instrumental Activities of Daily Living (IADL) Questionnaire | 1-month | 10.8 score on a scale |
| Open Radical Cystectomy | Measures of Functional Independence as Assessed by the Instrumental Activities of Daily Living (IADL) Questionnaire | 3-months | 9.5 score on a scale |
| Open Radical Cystectomy | Measures of Functional Independence as Assessed by the Instrumental Activities of Daily Living (IADL) Questionnaire | 6-months | 8.6 score on a scale |
| Robotic Assisted Radical Cystectomy | Measures of Functional Independence as Assessed by the Instrumental Activities of Daily Living (IADL) Questionnaire | 6-months | 8.7 score on a scale |
| Robotic Assisted Radical Cystectomy | Measures of Functional Independence as Assessed by the Instrumental Activities of Daily Living (IADL) Questionnaire | Baseline | 8.5 score on a scale |
| Robotic Assisted Radical Cystectomy | Measures of Functional Independence as Assessed by the Instrumental Activities of Daily Living (IADL) Questionnaire | 3-months | 8.9 score on a scale |
| Robotic Assisted Radical Cystectomy | Measures of Functional Independence as Assessed by the Instrumental Activities of Daily Living (IADL) Questionnaire | 1-month | 10.3 score on a scale |
Primary
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
Population: Not all length of stay data is available for all the study participants.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Open Radical Cystectomy | Number of Days of Post Operative Length of Hospital Stay | 7 days |
| Robotic Assisted Radical Cystectomy | Number of Days of Post Operative Length of Hospital Stay | 6 days |
Primary
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
Population: Not all participants in the study required blood transfusion and not all blood transfusion data was available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Open Radical Cystectomy | Number of Participants Requiring Blood Transfusion | Perioperative transfusion | 65 Participants |
| Open Radical Cystectomy | Number of Participants Requiring Blood Transfusion | Intraoperative transfusion | 46 Participants |
| Open Radical Cystectomy | Number of Participants Requiring Blood Transfusion | Postoperative transfusion | 54 Participants |
| Robotic Assisted Radical Cystectomy | Number of Participants Requiring Blood Transfusion | Perioperative transfusion | 35 Participants |
| Robotic Assisted Radical Cystectomy | Number of Participants Requiring Blood Transfusion | Intraoperative transfusion | 18 Participants |
| Robotic Assisted Radical Cystectomy | Number of Participants Requiring Blood Transfusion | Postoperative transfusion | 33 Participants |
Primary
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
Population: 1 participant in the RARC group did not have lymph node dissection.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Open Radical Cystectomy | Number of Participants Requiring Lymph Node Dissection | Extended Lymph Node Dissection | 84 Participants |
| Open Radical Cystectomy | Number of Participants Requiring Lymph Node Dissection | Standard Lymph Node Dissection | 68 Participants |
| Robotic Assisted Radical Cystectomy | Number of Participants Requiring Lymph Node Dissection | Extended Lymph Node Dissection | 76 Participants |
| Robotic Assisted Radical Cystectomy | Number of Participants Requiring Lymph Node Dissection | Standard Lymph Node Dissection | 73 Participants |
Primary
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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Open Radical Cystectomy | Number of Participants With Positive Margins | Positive surgical margins | 7 Participants |
| Open Radical Cystectomy | Number of Participants With Positive Margins | Positive bladder margins | 5 Participants |
| Open Radical Cystectomy | Number of Participants With Positive Margins | Positive urethral margin | 4 Participants |
| Robotic Assisted Radical Cystectomy | Number of Participants With Positive Margins | Positive surgical margins | 9 Participants |
| Robotic Assisted Radical Cystectomy | Number of Participants With Positive Margins | Positive bladder margins | 6 Participants |
| Robotic Assisted Radical Cystectomy | Number of Participants With Positive Margins | Positive urethral margin | 3 Participants |
Primary
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
Population: 90 day complication using Clavien Grading system
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Open Radical Cystectomy | Number of Participants With Post-surgical Complications | Clavien grade 0 | 47 Participants |
| Open Radical Cystectomy | Number of Participants With Post-surgical Complications | Clavien grade I | 20 Participants |
| Open Radical Cystectomy | Number of Participants With Post-surgical Complications | Clavien grade II | 51 Participants |
| Open Radical Cystectomy | Number of Participants With Post-surgical Complications | Clavien grade III | 28 Participants |
| Open Radical Cystectomy | Number of Participants With Post-surgical Complications | Clavien grade IV | 2 Participants |
| Open Radical Cystectomy | Number of Participants With Post-surgical Complications | Clavien grade V | 4 Participants |
| Robotic Assisted Radical Cystectomy | Number of Participants With Post-surgical Complications | Clavien grade IV | 0 Participants |
| Robotic Assisted Radical Cystectomy | Number of Participants With Post-surgical Complications | Clavien grade 0 | 49 Participants |
| Robotic Assisted Radical Cystectomy | Number of Participants With Post-surgical Complications | Clavien grade III | 29 Participants |
| Robotic Assisted Radical Cystectomy | Number of Participants With Post-surgical Complications | Clavien grade I | 24 Participants |
| Robotic Assisted Radical Cystectomy | Number of Participants With Post-surgical Complications | Clavien grade V | 4 Participants |
| Robotic Assisted Radical Cystectomy | Number of Participants With Post-surgical Complications | Clavien grade II | 44 Participants |
Primary
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Open Radical Cystectomy | Percentage of Participants With 2-year Progression Free Survival (PFS) | 71.6 percentage of participants |
| Robotic Assisted Radical Cystectomy | Percentage of Participants With 2-year Progression Free Survival (PFS) | 72.3 percentage of participants |
Primary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Open Radical Cystectomy | Percentage of Participants With 3-year Progression Free Survival (PFS) | 65.4 Percent of participants |
| Robotic Assisted Radical Cystectomy | Percentage of Participants With 3-year Progression Free Survival (PFS) | 68.4 Percent of participants |
Primary
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
Population: Number of participants included was based on the data available at specific time points.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Open Radical Cystectomy | Performance Related Measures of Functional Independence as Assessed by the Hand Grip Strength Test | Baseline | 37.4 kg |
| Open Radical Cystectomy | Performance Related Measures of Functional Independence as Assessed by the Hand Grip Strength Test | 1-month | 34.5 kg |
| Open Radical Cystectomy | Performance Related Measures of Functional Independence as Assessed by the Hand Grip Strength Test | 3-months | 35.1 kg |
| Open Radical Cystectomy | Performance Related Measures of Functional Independence as Assessed by the Hand Grip Strength Test | 6-months | 36.4 kg |
| Robotic Assisted Radical Cystectomy | Performance Related Measures of Functional Independence as Assessed by the Hand Grip Strength Test | 6-months | 34.9 kg |
| Robotic Assisted Radical Cystectomy | Performance Related Measures of Functional Independence as Assessed by the Hand Grip Strength Test | Baseline | 36.2 kg |
| Robotic Assisted Radical Cystectomy | Performance Related Measures of Functional Independence as Assessed by the Hand Grip Strength Test | 3-months | 34.2 kg |
| Robotic Assisted Radical Cystectomy | Performance Related Measures of Functional Independence as Assessed by the Hand Grip Strength Test | 1-month | 34.1 kg |
Primary
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
Population: Number of participants included was based on the data available at specific time points.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Open Radical Cystectomy | Performance Related Measures of Functional Independence as Assessed by the Time Up and Go (TUG) Walking Test | 6-months | 12.2 seconds |
| Open Radical Cystectomy | Performance Related Measures of Functional Independence as Assessed by the Time Up and Go (TUG) Walking Test | Baseline | 12.5 seconds |
| Open Radical Cystectomy | Performance Related Measures of Functional Independence as Assessed by the Time Up and Go (TUG) Walking Test | 1-month | 13.6 seconds |
| Open Radical Cystectomy | Performance Related Measures of Functional Independence as Assessed by the Time Up and Go (TUG) Walking Test | 3-months | 12.8 seconds |
| Robotic Assisted Radical Cystectomy | Performance Related Measures of Functional Independence as Assessed by the Time Up and Go (TUG) Walking Test | 3-months | 11.2 seconds |
| Robotic Assisted Radical Cystectomy | Performance Related Measures of Functional Independence as Assessed by the Time Up and Go (TUG) Walking Test | 6-months | 11.2 seconds |
| Robotic Assisted Radical Cystectomy | Performance Related Measures of Functional Independence as Assessed by the Time Up and Go (TUG) Walking Test | 1-month | 13.1 seconds |
| Robotic Assisted Radical Cystectomy | Performance Related Measures of Functional Independence as Assessed by the Time Up and Go (TUG) Walking Test | Baseline | 11.7 seconds |
Primary
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
Population: Not all enrolled participants completed the QOL questionnaires.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Open Radical Cystectomy | Quality of Life (QOL) Outcomes | Baseline Visit | 120.9 score on a scale |
| Open Radical Cystectomy | Quality of Life (QOL) Outcomes | 3 Month Visit | 125.2 score on a scale |
| Open Radical Cystectomy | Quality of Life (QOL) Outcomes | 6 Month Visit | 127.5 score on a scale |
| Robotic Assisted Radical Cystectomy | Quality of Life (QOL) Outcomes | Baseline Visit | 120.1 score on a scale |
| Robotic Assisted Radical Cystectomy | Quality of Life (QOL) Outcomes | 3 Month Visit | 122.8 score on a scale |
| Robotic Assisted Radical Cystectomy | Quality of Life (QOL) Outcomes | 6 Month Visit | 126.0 score on a scale |
Primary
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
Population: Not all participants completed the questionnaire at the different visits.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Open Radical Cystectomy | Quality of Life (QOL) Outcomes as Assessed by the Functional Assessment of Cancer Therapy - Vanderbilt Cystectomy Index (FACT-VCI) Questionnaire | Emotional Wellbeing baseline | 17.7 score on a scale |
| Open Radical Cystectomy | Quality of Life (QOL) Outcomes as Assessed by the Functional Assessment of Cancer Therapy - Vanderbilt Cystectomy Index (FACT-VCI) Questionnaire | Physical Wellbeing 3 months | 22.8 score on a scale |
| Open Radical Cystectomy | Quality of Life (QOL) Outcomes as Assessed by the Functional Assessment of Cancer Therapy - Vanderbilt Cystectomy Index (FACT-VCI) Questionnaire | Physical Wellbeing 6 months | 23.9 score on a scale |
| Open Radical Cystectomy | Quality of Life (QOL) Outcomes as Assessed by the Functional Assessment of Cancer Therapy - Vanderbilt Cystectomy Index (FACT-VCI) Questionnaire | Social Wellbeing baseline | 23.5 score on a scale |
| Open Radical Cystectomy | Quality of Life (QOL) Outcomes as Assessed by the Functional Assessment of Cancer Therapy - Vanderbilt Cystectomy Index (FACT-VCI) Questionnaire | Social Wellbeing 3 months | 22.6 score on a scale |
| Open Radical Cystectomy | Quality of Life (QOL) Outcomes as Assessed by the Functional Assessment of Cancer Therapy - Vanderbilt Cystectomy Index (FACT-VCI) Questionnaire | Social Wellbeing 6 months | 23.3 score on a scale |
| Open Radical Cystectomy | Quality of Life (QOL) Outcomes as Assessed by the Functional Assessment of Cancer Therapy - Vanderbilt Cystectomy Index (FACT-VCI) Questionnaire | Physical Wellbeing baseline | 23.4 score on a scale |
| Open Radical Cystectomy | Quality of Life (QOL) Outcomes as Assessed by the Functional Assessment of Cancer Therapy - Vanderbilt Cystectomy Index (FACT-VCI) Questionnaire | Emotional Wellbeing 3 months | 19.9 score on a scale |
| Open Radical Cystectomy | Quality of Life (QOL) Outcomes as Assessed by the Functional Assessment of Cancer Therapy - Vanderbilt Cystectomy Index (FACT-VCI) Questionnaire | Emotional Wellbeing 6 months | 20.0 score on a scale |
| Open Radical Cystectomy | Quality of Life (QOL) Outcomes as Assessed by the Functional Assessment of Cancer Therapy - Vanderbilt Cystectomy Index (FACT-VCI) Questionnaire | Functional Wellbeing baseline | 18.4 score on a scale |
| Open Radical Cystectomy | Quality of Life (QOL) Outcomes as Assessed by the Functional Assessment of Cancer Therapy - Vanderbilt Cystectomy Index (FACT-VCI) Questionnaire | Functional Wellbeing 3 months | 19.3 score on a scale |
| Open Radical Cystectomy | Quality of Life (QOL) Outcomes as Assessed by the Functional Assessment of Cancer Therapy - Vanderbilt Cystectomy Index (FACT-VCI) Questionnaire | Functional Wellbeing 6 months | 19.7 score on a scale |
| Open Radical Cystectomy | Quality of Life (QOL) Outcomes as Assessed by the Functional Assessment of Cancer Therapy - Vanderbilt Cystectomy Index (FACT-VCI) Questionnaire | FACT-BL-Cys Baseline | 36.7 score on a scale |
| Open Radical Cystectomy | Quality of Life (QOL) Outcomes as Assessed by the Functional Assessment of Cancer Therapy - Vanderbilt Cystectomy Index (FACT-VCI) Questionnaire | FACT-BL-Cys 3 months | 38.2 score on a scale |
| Open Radical Cystectomy | Quality of Life (QOL) Outcomes as Assessed by the Functional Assessment of Cancer Therapy - Vanderbilt Cystectomy Index (FACT-VCI) Questionnaire | FACT-BL-Cys 6 months | 39.4 score on a scale |
| Open Radical Cystectomy | Quality of Life (QOL) Outcomes as Assessed by the Functional Assessment of Cancer Therapy - Vanderbilt Cystectomy Index (FACT-VCI) Questionnaire | Trial outcome index Baseline | 78.9 score on a scale |
| Open Radical Cystectomy | Quality of Life (QOL) Outcomes as Assessed by the Functional Assessment of Cancer Therapy - Vanderbilt Cystectomy Index (FACT-VCI) Questionnaire | Trial outcome index 3 months | 80.7 score on a scale |
| Open Radical Cystectomy | Quality of Life (QOL) Outcomes as Assessed by the Functional Assessment of Cancer Therapy - Vanderbilt Cystectomy Index (FACT-VCI) Questionnaire | Trial outcome index 6 months | 83.2 score on a scale |
| Open Radical Cystectomy | Quality of Life (QOL) Outcomes as Assessed by the Functional Assessment of Cancer Therapy - Vanderbilt Cystectomy Index (FACT-VCI) Questionnaire | FACT-G baseline | 83.5 score on a scale |
| Open Radical Cystectomy | Quality of Life (QOL) Outcomes as Assessed by the Functional Assessment of Cancer Therapy - Vanderbilt Cystectomy Index (FACT-VCI) Questionnaire | FACT-G 3 months | 85.8 score on a scale |
| Open Radical Cystectomy | Quality of Life (QOL) Outcomes as Assessed by the Functional Assessment of Cancer Therapy - Vanderbilt Cystectomy Index (FACT-VCI) Questionnaire | FACT-G 6 months | 87.4 score on a scale |
| Open Radical Cystectomy | Quality of Life (QOL) Outcomes as Assessed by the Functional Assessment of Cancer Therapy - Vanderbilt Cystectomy Index (FACT-VCI) Questionnaire | FACT-BL-Cys Total baseline | 120.9 score on a scale |
| Open Radical Cystectomy | Quality of Life (QOL) Outcomes as Assessed by the Functional Assessment of Cancer Therapy - Vanderbilt Cystectomy Index (FACT-VCI) Questionnaire | FACT-BL-Cys Total 3 months | 125.2 score on a scale |
| Open Radical Cystectomy | Quality of Life (QOL) Outcomes as Assessed by the Functional Assessment of Cancer Therapy - Vanderbilt Cystectomy Index (FACT-VCI) Questionnaire | FACT-BL-Cys Total 6 months | 127.5 score on a scale |
| Robotic Assisted Radical Cystectomy | Quality of Life (QOL) Outcomes as Assessed by the Functional Assessment of Cancer Therapy - Vanderbilt Cystectomy Index (FACT-VCI) Questionnaire | FACT-BL-Cys Total 3 months | 122.8 score on a scale |
| Robotic Assisted Radical Cystectomy | Quality of Life (QOL) Outcomes as Assessed by the Functional Assessment of Cancer Therapy - Vanderbilt Cystectomy Index (FACT-VCI) Questionnaire | Physical Wellbeing baseline | 22.9 score on a scale |
| Robotic Assisted Radical Cystectomy | Quality of Life (QOL) Outcomes as Assessed by the Functional Assessment of Cancer Therapy - Vanderbilt Cystectomy Index (FACT-VCI) Questionnaire | FACT-BL-Cys Baseline | 37.4 score on a scale |
| Robotic Assisted Radical Cystectomy | Quality of Life (QOL) Outcomes as Assessed by the Functional Assessment of Cancer Therapy - Vanderbilt Cystectomy Index (FACT-VCI) Questionnaire | Physical Wellbeing 3 months | 23.2 score on a scale |
| Robotic Assisted Radical Cystectomy | Quality of Life (QOL) Outcomes as Assessed by the Functional Assessment of Cancer Therapy - Vanderbilt Cystectomy Index (FACT-VCI) Questionnaire | FACT-G baseline | 82.4 score on a scale |
| Robotic Assisted Radical Cystectomy | Quality of Life (QOL) Outcomes as Assessed by the Functional Assessment of Cancer Therapy - Vanderbilt Cystectomy Index (FACT-VCI) Questionnaire | Physical Wellbeing 6 months | 23.2 score on a scale |
| Robotic Assisted Radical Cystectomy | Quality of Life (QOL) Outcomes as Assessed by the Functional Assessment of Cancer Therapy - Vanderbilt Cystectomy Index (FACT-VCI) Questionnaire | FACT-BL-Cys 3 months | 37.9 score on a scale |
| Robotic Assisted Radical Cystectomy | Quality of Life (QOL) Outcomes as Assessed by the Functional Assessment of Cancer Therapy - Vanderbilt Cystectomy Index (FACT-VCI) Questionnaire | Social Wellbeing baseline | 23.5 score on a scale |
| Robotic Assisted Radical Cystectomy | Quality of Life (QOL) Outcomes as Assessed by the Functional Assessment of Cancer Therapy - Vanderbilt Cystectomy Index (FACT-VCI) Questionnaire | FACT-BL-Cys Total baseline | 120.1 score on a scale |
| Robotic Assisted Radical Cystectomy | Quality of Life (QOL) Outcomes as Assessed by the Functional Assessment of Cancer Therapy - Vanderbilt Cystectomy Index (FACT-VCI) Questionnaire | Social Wellbeing 3 months | 23.1 score on a scale |
| Robotic Assisted Radical Cystectomy | Quality of Life (QOL) Outcomes as Assessed by the Functional Assessment of Cancer Therapy - Vanderbilt Cystectomy Index (FACT-VCI) Questionnaire | FACT-BL-Cys 6 months | 39.3 score on a scale |
| Robotic Assisted Radical Cystectomy | Quality of Life (QOL) Outcomes as Assessed by the Functional Assessment of Cancer Therapy - Vanderbilt Cystectomy Index (FACT-VCI) Questionnaire | Social Wellbeing 6 months | 23.3 score on a scale |
| Robotic Assisted Radical Cystectomy | Quality of Life (QOL) Outcomes as Assessed by the Functional Assessment of Cancer Therapy - Vanderbilt Cystectomy Index (FACT-VCI) Questionnaire | FACT-G 3 months | 84.2 score on a scale |
| Robotic Assisted Radical Cystectomy | Quality of Life (QOL) Outcomes as Assessed by the Functional Assessment of Cancer Therapy - Vanderbilt Cystectomy Index (FACT-VCI) Questionnaire | Emotional Wellbeing baseline | 17.5 score on a scale |
| Robotic Assisted Radical Cystectomy | Quality of Life (QOL) Outcomes as Assessed by the Functional Assessment of Cancer Therapy - Vanderbilt Cystectomy Index (FACT-VCI) Questionnaire | Trial outcome index Baseline | 78.9 score on a scale |
| Robotic Assisted Radical Cystectomy | Quality of Life (QOL) Outcomes as Assessed by the Functional Assessment of Cancer Therapy - Vanderbilt Cystectomy Index (FACT-VCI) Questionnaire | Emotional Wellbeing 3 months | 19.5 score on a scale |
| Robotic Assisted Radical Cystectomy | Quality of Life (QOL) Outcomes as Assessed by the Functional Assessment of Cancer Therapy - Vanderbilt Cystectomy Index (FACT-VCI) Questionnaire | FACT-BL-Cys Total 6 months | 126.0 score on a scale |
| Robotic Assisted Radical Cystectomy | Quality of Life (QOL) Outcomes as Assessed by the Functional Assessment of Cancer Therapy - Vanderbilt Cystectomy Index (FACT-VCI) Questionnaire | Emotional Wellbeing 6 months | 19.4 score on a scale |
| Robotic Assisted Radical Cystectomy | Quality of Life (QOL) Outcomes as Assessed by the Functional Assessment of Cancer Therapy - Vanderbilt Cystectomy Index (FACT-VCI) Questionnaire | Trial outcome index 3 months | 79.3 score on a scale |
| Robotic Assisted Radical Cystectomy | Quality of Life (QOL) Outcomes as Assessed by the Functional Assessment of Cancer Therapy - Vanderbilt Cystectomy Index (FACT-VCI) Questionnaire | Functional Wellbeing baseline | 18.4 score on a scale |
| Robotic Assisted Radical Cystectomy | Quality of Life (QOL) Outcomes as Assessed by the Functional Assessment of Cancer Therapy - Vanderbilt Cystectomy Index (FACT-VCI) Questionnaire | FACT-G 6 months | 85.9 score on a scale |
| Robotic Assisted Radical Cystectomy | Quality of Life (QOL) Outcomes as Assessed by the Functional Assessment of Cancer Therapy - Vanderbilt Cystectomy Index (FACT-VCI) Questionnaire | Functional Wellbeing 3 months | 17.9 score on a scale |
| Robotic Assisted Radical Cystectomy | Quality of Life (QOL) Outcomes as Assessed by the Functional Assessment of Cancer Therapy - Vanderbilt Cystectomy Index (FACT-VCI) Questionnaire | Trial outcome index 6 months | 81.1 score on a scale |
| Robotic Assisted Radical Cystectomy | Quality of Life (QOL) Outcomes as Assessed by the Functional Assessment of Cancer Therapy - Vanderbilt Cystectomy Index (FACT-VCI) Questionnaire | Functional Wellbeing 6 months | 18.5 score on a scale |
Primary
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
Population: Number of participants changes depending on their data availability at different time points.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Open Radical Cystectomy | Quality of Life (QOL) Outcomes as Assessed by the Short Form 8 (SF-8) Questionnaire | Baseline (PCS) | 45.3 percentile |
| Open Radical Cystectomy | Quality of Life (QOL) Outcomes as Assessed by the Short Form 8 (SF-8) Questionnaire | 3-months (PCS) | 46.2 percentile |
| Open Radical Cystectomy | Quality of Life (QOL) Outcomes as Assessed by the Short Form 8 (SF-8) Questionnaire | 6-months(PCS) | 49.6 percentile |
| Open Radical Cystectomy | Quality of Life (QOL) Outcomes as Assessed by the Short Form 8 (SF-8) Questionnaire | Baseline (MCS) | 48.1 percentile |
| Open Radical Cystectomy | Quality of Life (QOL) Outcomes as Assessed by the Short Form 8 (SF-8) Questionnaire | 3-months (MCS) | 50.3 percentile |
| Open Radical Cystectomy | Quality of Life (QOL) Outcomes as Assessed by the Short Form 8 (SF-8) Questionnaire | 6-months(MCS) | 51.8 percentile |
| Robotic Assisted Radical Cystectomy | Quality of Life (QOL) Outcomes as Assessed by the Short Form 8 (SF-8) Questionnaire | 3-months (MCS) | 49.1 percentile |
| Robotic Assisted Radical Cystectomy | Quality of Life (QOL) Outcomes as Assessed by the Short Form 8 (SF-8) Questionnaire | Baseline (PCS) | 46.1 percentile |
| Robotic Assisted Radical Cystectomy | Quality of Life (QOL) Outcomes as Assessed by the Short Form 8 (SF-8) Questionnaire | Baseline (MCS) | 48.1 percentile |
| Robotic Assisted Radical Cystectomy | Quality of Life (QOL) Outcomes as Assessed by the Short Form 8 (SF-8) Questionnaire | 3-months (PCS) | 45.7 percentile |
| Robotic Assisted Radical Cystectomy | Quality of Life (QOL) Outcomes as Assessed by the Short Form 8 (SF-8) Questionnaire | 6-months(MCS) | 49.2 percentile |
| Robotic Assisted Radical Cystectomy | Quality of Life (QOL) Outcomes as Assessed by the Short Form 8 (SF-8) Questionnaire | 6-months(PCS) | 47.5 percentile |
Primary
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
Population: Number of participants included was based on the data available at specific time point.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Open Radical Cystectomy | Total Number of Participants Requiring Intra-operative Fluid Requirement | 46 Participants |
| Robotic Assisted Radical Cystectomy | Total Number of Participants Requiring Intra-operative Fluid Requirement | 18 Participants |
Primary
Total Postoperative Analgesic Requirements
Total postoperative analgesic requirements in milli grams
Time frame: At time of cystectomy, approximately 1 hour
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Open Radical Cystectomy | Total Postoperative Analgesic Requirements | 157.7 mg | Standard Deviation 222.2 |
| Robotic Assisted Radical Cystectomy | Total Postoperative Analgesic Requirements | 167.2 mg | Standard Deviation 264.6 |
Secondary
Cost
Fixed and variable costs associated with the procedure.
Time frame: Day 7
Population: Cost data was specified as a secondary endpoint in the protocol, but data could not be collected from all sites due to proprietary reasons.