Trial Outcomes & Findings for Open Vs Robotic-Assisted Radical Cystectomy: A Randomized Trial (NCT NCT01157676)

Last Updated: 2020-11-03

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

350 participants

Primary outcome timeframe

24 months

Results posted on

2020-11-03

Participant Flow

Participant milestones

Participant milestones
Measure	Open Radical Cystectomy Standard of care treatment	Robotic Assisted Radical Cystectomy Standard of care treatment using DaVinci robot
Enrollment STARTED	174	176
Enrollment COMPLETED	174	176
Enrollment NOT COMPLETED	0	0
Randomization STARTED	174	176
Randomization COMPLETED	153	159
Randomization NOT COMPLETED	21	17
Surgery STARTED	153	159
Surgery COMPLETED	152	150
Surgery NOT COMPLETED	1	9

Reasons for withdrawal

Reasons for withdrawal
Measure	Open Radical Cystectomy Standard of care treatment	Robotic Assisted Radical Cystectomy Standard of care treatment using DaVinci robot
Randomization Death	1	1
Randomization unresectable	2	3
Randomization Withdrawal by Subject	17	13
Randomization Physician Decision	1	0
Surgery underwent open cystectomy	0	4
Surgery converted to open procedure	0	5
Surgery underwent robotic cystectomy	1	0

Baseline Characteristics

Data analysis completed for participants who finished the study as per protocol.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Open Cystectomy n=152 Participants Standard of care treatment, open cystectomy	Robotic Assisted Radical Cystectomy n=150 Participants Standard of care treatment, robotic assisted radical cystectomy	Total n=302 Participants Total of all reporting groups
Age, Continuous	67 years n=5 Participants	70 years n=7 Participants	68 years n=5 Participants
Sex: Female, Male Female	24 Participants n=5 Participants • Data analysis completed for participants who finished the study as per protocol.	24 Participants n=7 Participants • Data analysis completed for participants who finished the study as per protocol.	48 Participants n=5 Participants • Data analysis completed for participants who finished the study as per protocol.
Sex: Female, Male Male	128 Participants n=5 Participants • Data analysis completed for participants who finished the study as per protocol.	126 Participants n=7 Participants • Data analysis completed for participants who finished the study as per protocol.	254 Participants n=5 Participants • Data analysis completed for participants who finished the study as per protocol.
Ethnicity (NIH/OMB) Hispanic or Latino	11 Participants n=5 Participants • Data analysis were completed only for the participants that completed the study.	12 Participants n=7 Participants • Data analysis were completed only for the participants that completed the study.	23 Participants n=5 Participants • Data analysis were completed only for the participants that completed the study.
Ethnicity (NIH/OMB) Not Hispanic or Latino	138 Participants n=5 Participants • Data analysis were completed only for the participants that completed the study.	135 Participants n=7 Participants • Data analysis were completed only for the participants that completed the study.	273 Participants n=5 Participants • Data analysis were completed only for the participants that completed the study.
Ethnicity (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants • Data analysis were completed only for the participants that completed the study.	3 Participants n=7 Participants • Data analysis were completed only for the participants that completed the study.	6 Participants n=5 Participants • Data analysis were completed only for the participants that completed the study.
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants • Data analysis completed for participants who finished the study as per protocol.	1 Participants n=7 Participants • Data analysis completed for participants who finished the study as per protocol.	1 Participants n=5 Participants • Data analysis completed for participants who finished the study as per protocol.
Race (NIH/OMB) Asian	2 Participants n=5 Participants • Data analysis completed for participants who finished the study as per protocol.	2 Participants n=7 Participants • Data analysis completed for participants who finished the study as per protocol.	4 Participants n=5 Participants • Data analysis completed for participants who finished the study as per protocol.
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants • Data analysis completed for participants who finished the study as per protocol.	0 Participants n=7 Participants • Data analysis completed for participants who finished the study as per protocol.	0 Participants n=5 Participants • Data analysis completed for participants who finished the study as per protocol.
Race (NIH/OMB) Black or African American	6 Participants n=5 Participants • Data analysis completed for participants who finished the study as per protocol.	10 Participants n=7 Participants • Data analysis completed for participants who finished the study as per protocol.	16 Participants n=5 Participants • Data analysis completed for participants who finished the study as per protocol.
Race (NIH/OMB) White	142 Participants n=5 Participants • Data analysis completed for participants who finished the study as per protocol.	133 Participants n=7 Participants • Data analysis completed for participants who finished the study as per protocol.	275 Participants n=5 Participants • Data analysis completed for participants who finished the study as per protocol.
Race (NIH/OMB) More than one race	0 Participants n=5 Participants • Data analysis completed for participants who finished the study as per protocol.	1 Participants n=7 Participants • Data analysis completed for participants who finished the study as per protocol.	1 Participants n=5 Participants • Data analysis completed for participants who finished the study as per protocol.
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants • Data analysis completed for participants who finished the study as per protocol.	3 Participants n=7 Participants • Data analysis completed for participants who finished the study as per protocol.	5 Participants n=5 Participants • Data analysis completed for participants who finished the study as per protocol.

PRIMARY outcome

Timeframe: 24 months

Outcome measures

Outcome measures
Measure	Open Radical Cystectomy n=152 Participants Standard of care treatment	Robotic Assisted Radical Cystectomy n=150 Participants Standard of care treatment using the DaVinci robot.
Percentage of Participants With 2-year Progression Free Survival (PFS)	71.6 percentage of participants Interval 63.6 to 78.2	72.3 percentage of participants Interval 64.3 to 78.8

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Open Radical Cystectomy n=152 Participants Standard of care treatment	Robotic Assisted Radical Cystectomy n=150 Participants Standard of care treatment using the DaVinci robot.
Number of Participants With Positive Margins Positive surgical margins	7 Participants	9 Participants
Number of Participants With Positive Margins Positive bladder margins	5 Participants	6 Participants
Number of Participants With Positive Margins Positive urethral margin	4 Participants	3 Participants

PRIMARY outcome

Timeframe: At time of cystectomy, approximately 1 hour

Population: 1 participant in the RARC group did not have lymph node dissection.

Evaluated are the number of participants requiring extended or standard lymph node dissection

Outcome measures

Outcome measures
Measure	Open Radical Cystectomy n=152 Participants Standard of care treatment	Robotic Assisted Radical Cystectomy n=149 Participants Standard of care treatment using the DaVinci robot.
Number of Participants Requiring Lymph Node Dissection Extended Lymph Node Dissection	84 Participants	76 Participants
Number of Participants Requiring Lymph Node Dissection Standard Lymph Node Dissection	68 Participants	73 Participants

PRIMARY outcome

Timeframe: at baseline, 3 month, and 6 months

Population: Not all enrolled participants completed the QOL questionnaires.

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.

Outcome measures

Outcome measures
Measure	Open Radical Cystectomy n=111 Participants Standard of care treatment	Robotic Assisted Radical Cystectomy n=108 Participants Standard of care treatment using the DaVinci robot.
Quality of Life (QOL) Outcomes Baseline Visit	120.9 score on a scale Interval 115.0 to 126.8	120.1 score on a scale Interval 114.5 to 125.8
Quality of Life (QOL) Outcomes 3 Month Visit	125.2 score on a scale Interval 119.3 to 131.1	122.8 score on a scale Interval 117.2 to 128.3
Quality of Life (QOL) Outcomes 6 Month Visit	127.5 score on a scale Interval 121.7 to 133.3	126.0 score on a scale Interval 120.4 to 131.6

PRIMARY outcome

Timeframe: 90 days post operative

Population: 90 day complication using Clavien Grading system

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.

Outcome measures

Outcome measures
Measure	Open Radical Cystectomy n=152 Participants Standard of care treatment	Robotic Assisted Radical Cystectomy n=150 Participants Standard of care treatment using the DaVinci robot.
Number of Participants With Post-surgical Complications Clavien grade 0	47 Participants	49 Participants
Number of Participants With Post-surgical Complications Clavien grade I	20 Participants	24 Participants
Number of Participants With Post-surgical Complications Clavien grade II	51 Participants	44 Participants
Number of Participants With Post-surgical Complications Clavien grade III	28 Participants	29 Participants
Number of Participants With Post-surgical Complications Clavien grade IV	2 Participants	0 Participants
Number of Participants With Post-surgical Complications Clavien grade V	4 Participants	4 Participants

PRIMARY outcome

Timeframe: 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.

Perioperative measures such as EBL will be evaluated by measuring the amount of participant blood loss in ml.

Outcome measures

Outcome measures
Measure	Open Radical Cystectomy n=149 Participants Standard of care treatment	Robotic Assisted Radical Cystectomy n=148 Participants Standard of care treatment using the DaVinci robot.
Amount of Estimated Blood Loss (EBL) in ml	700 ml Interval 500.0 to 1000.0	300 ml Interval 200.0 to 500.0

PRIMARY outcome

Timeframe: 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.

Number of participants requiring peri, intra, and post operative blood transfusion.

Outcome measures

Outcome measures
Measure	Open Radical Cystectomy n=143 Participants Standard of care treatment	Robotic Assisted Radical Cystectomy n=143 Participants Standard of care treatment using the DaVinci robot.
Number of Participants Requiring Blood Transfusion Postoperative transfusion	54 Participants	33 Participants
Number of Participants Requiring Blood Transfusion Perioperative transfusion	65 Participants	35 Participants
Number of Participants Requiring Blood Transfusion Intraoperative transfusion	46 Participants	18 Participants

PRIMARY outcome

Timeframe: Day 10 post surgery

Population: Not all length of stay data is available for all the study participants.

Number of days of post operative length of hospital stay will be evaluated

Outcome measures

Outcome measures
Measure	Open Radical Cystectomy n=146 Participants Standard of care treatment	Robotic Assisted Radical Cystectomy n=139 Participants Standard of care treatment using the DaVinci robot.
Number of Days of Post Operative Length of Hospital Stay	7 days Interval 6.0 to 10.0	6 days Interval 5.0 to 10.0

PRIMARY outcome

Timeframe: At time of cystectomy, approximately 1 hour

Population: The length of operative time is not available for all participants.

Length of minutes of cystectomy procedure

Outcome measures

Outcome measures
Measure	Open Radical Cystectomy n=146 Participants Standard of care treatment	Robotic Assisted Radical Cystectomy n=139 Participants Standard of care treatment using the DaVinci robot.
Length of Operative Time	361 minutes Interval 281.0 to 450.0	428 minutes Interval 322.0 to 509.0

PRIMARY outcome

Timeframe: 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.

Serum Hemoglobin (Hb) and Albumin will be reported in grams per deciliters (g/dL)

Outcome measures

Outcome measures
Measure	Open Radical Cystectomy n=152 Participants Standard of care treatment	Robotic Assisted Radical Cystectomy n=150 Participants Standard of care treatment using the DaVinci robot.
Laboratory Values Baseline (Hb)	12.84 g/dL Standard Deviation 1.87	13.11 g/dL Standard Deviation 1.84
Laboratory Values 3-months (Hb)	12.05 g/dL Standard Deviation 1.81	12.17 g/dL Standard Deviation 2.06
Laboratory Values 6-months (Hb)	12.73 g/dL Standard Deviation 2.06	12.54 g/dL Standard Deviation 1.89
Laboratory Values 12-months (Hb)	12.95 g/dL Standard Deviation 2.48	13.25 g/dL Standard Deviation 2.11
Laboratory Values 24-months (Hb)	13.47 g/dL Standard Deviation 1.89	13.65 g/dL Standard Deviation 2.03
Laboratory Values Baseline (Albumin)	3.97 g/dL Standard Deviation 0.71	4.00 g/dL Standard Deviation 0.55
Laboratory Values 6-weeks (Albumin)	3.66 g/dL Standard Deviation 0.62	3.70 g/dL Standard Deviation 0.62
Laboratory Values 3-months (Albumin)	3.88 g/dL Standard Deviation 0.59	3.92 g/dL Standard Deviation 0.60
Laboratory Values 6-months (Albumin)	4.02 g/dL Standard Deviation 0.43	4.04 g/dL Standard Deviation 0.40
Laboratory Values 12-months (Albumin)	3.96 g/dL Standard Deviation 0.93	4.04 g/dL Standard Deviation 0.46
Laboratory Values 24-months (Albumin)	4.00 g/dL Standard Deviation 0.46	3.91 g/dL Standard Deviation 0.75
Laboratory Values 36-months (Albumin)	4.00 g/dL Standard Deviation 0.44	3.97 g/dL Standard Deviation 0.65
Laboratory Values 6-weeks (Hb)	11.19 g/dL Standard Deviation 1.58	11.62 g/dL Standard Deviation 1.72
Laboratory Values 36-months (Hb)	14.14 g/dL Standard Deviation 1.52	13.64 g/dL Standard Deviation 2.59

PRIMARY outcome

Timeframe: baseline, 1 month , 3 months, 6 months

Population: Number of participants changes depending on their data availability at different time points.

Participant reported ADL questionnaire is a 7 item questionnaire with scores ranging from 7-21 with a lower score indicating increased independence.

Outcome measures

Outcome measures
Measure	Open Radical Cystectomy n=152 Participants Standard of care treatment	Robotic Assisted Radical Cystectomy n=150 Participants Standard of care treatment using the DaVinci robot.
Measures of Functional Independence as Assessed by the Activities of Daily Living (ADL) Questionnaire Baseline	7.2 score on a scale Interval 7.1 to 7.3	7.2 score on a scale Interval 7.0 to 7.4
Measures of Functional Independence as Assessed by the Activities of Daily Living (ADL) Questionnaire 1-month	7.8 score on a scale Interval 7.5 to 8.2	7.6 score on a scale Interval 7.3 to 7.9
Measures of Functional Independence as Assessed by the Activities of Daily Living (ADL) Questionnaire 6-months	7.1 score on a scale Interval 7.0 to 7.2	7.2 score on a scale Interval 7.0 to 7.4
Measures of Functional Independence as Assessed by the Activities of Daily Living (ADL) Questionnaire 3-months	7.5 score on a scale Interval 7.1 to 7.8	7.3 score on a scale Interval 7.1 to 7.6

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Open Radical Cystectomy n=152 Participants Standard of care treatment	Robotic Assisted Radical Cystectomy n=150 Participants Standard of care treatment using the DaVinci robot.
Percentage of Participants With 3-year Progression Free Survival (PFS)	65.4 Percent of participants Interval 56.8 to 72.7	68.4 Percent of participants Interval 60.1 to 75.3

PRIMARY outcome

Timeframe: baseline, 3 month, and 6 month

Population: Number of participants changes depending on their data availability at different time points.

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.

Outcome measures

Outcome measures
Measure	Open Radical Cystectomy n=152 Participants Standard of care treatment	Robotic Assisted Radical Cystectomy n=150 Participants Standard of care treatment using the DaVinci robot.
Quality of Life (QOL) Outcomes as Assessed by the Short Form 8 (SF-8) Questionnaire Baseline (PCS)	45.3 percentile Interval 43.2 to 47.4	46.1 percentile Interval 44.1 to 48.0
Quality of Life (QOL) Outcomes as Assessed by the Short Form 8 (SF-8) Questionnaire 3-months (PCS)	46.2 percentile Interval 43.8 to 48.5	45.7 percentile Interval 43.5 to 47.9
Quality of Life (QOL) Outcomes as Assessed by the Short Form 8 (SF-8) Questionnaire 6-months(PCS)	49.6 percentile Interval 47.6 to 51.7	47.5 percentile Interval 45.6 to 49.3
Quality of Life (QOL) Outcomes as Assessed by the Short Form 8 (SF-8) Questionnaire Baseline (MCS)	48.1 percentile Interval 46.1 to 50.0	48.1 percentile Interval 46.4 to 49.9
Quality of Life (QOL) Outcomes as Assessed by the Short Form 8 (SF-8) Questionnaire 3-months (MCS)	50.3 percentile Interval 48.6 to 51.9	49.1 percentile Interval 47.2 to 51.1
Quality of Life (QOL) Outcomes as Assessed by the Short Form 8 (SF-8) Questionnaire 6-months(MCS)	51.8 percentile Interval 50.1 to 53.5	49.2 percentile Interval 47.2 to 51.3

PRIMARY outcome

Timeframe: At time of cystectomy, approximately 1 hour

Population: Number of participants included was based on the data available at specific time point.

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.

Outcome measures

Outcome measures
Measure	Open Radical Cystectomy n=136 Participants Standard of care treatment	Robotic Assisted Radical Cystectomy n=139 Participants Standard of care treatment using the DaVinci robot.
Total Number of Participants Requiring Intra-operative Fluid Requirement	46 Participants	18 Participants

PRIMARY outcome

Timeframe: At time of cystectomy, approximately 1 hour

Total postoperative analgesic requirements in milli grams

Outcome measures

Outcome measures
Measure	Open Radical Cystectomy n=152 Participants Standard of care treatment	Robotic Assisted Radical Cystectomy n=150 Participants Standard of care treatment using the DaVinci robot.
Total Postoperative Analgesic Requirements	157.7 mg Standard Deviation 222.2	167.2 mg Standard Deviation 264.6

PRIMARY outcome

Timeframe: 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.

Serum creatinine will be reported in milligrams per deciliters (mg/dL).

Outcome measures

Outcome measures
Measure	Open Radical Cystectomy n=152 Participants Standard of care treatment	Robotic Assisted Radical Cystectomy n=150 Participants Standard of care treatment using the DaVinci robot.
Creatinine Value. Baseline	1.17 mg/dL Standard Deviation 0.52	1.12 mg/dL Standard Deviation 0.50
Creatinine Value. 6-weeks	1.27 mg/dL Standard Deviation 0.67	1.28 mg/dL Standard Deviation 0.66
Creatinine Value. 3-months	1.16 mg/dL Standard Deviation 0.44	1.26 mg/dL Standard Deviation 0.71
Creatinine Value. 12-months	1.19 mg/dL Standard Deviation 0.43	1.25 mg/dL Standard Deviation 0.58
Creatinine Value. 24-months	1.26 mg/dL Standard Deviation 0.48	1.25 mg/dL Standard Deviation 0.62
Creatinine Value. 36-months	1.26 mg/dL Standard Deviation 0.53	1.21 mg/dL Standard Deviation 0.71
Creatinine Value. 6-months	1.21 mg/dL Standard Deviation 0.46	1.28 mg/dL Standard Deviation 0.57

PRIMARY outcome

Timeframe: baseline, 1 month, 3 months, 6 months

Population: Number of participants included was based on the data available at specific time points.

Participant reported IADL questionnaire is an 8 item questionnaire with scores ranging from 8-32 with a lower score indicating increased independence.

Outcome measures

Outcome measures
Measure	Open Radical Cystectomy n=152 Participants Standard of care treatment	Robotic Assisted Radical Cystectomy n=150 Participants Standard of care treatment using the DaVinci robot.
Measures of Functional Independence as Assessed by the Instrumental Activities of Daily Living (IADL) Questionnaire Baseline	8.8 score on a scale Interval 8.4 to 9.2	8.5 score on a scale Interval 8.2 to 8.7
Measures of Functional Independence as Assessed by the Instrumental Activities of Daily Living (IADL) Questionnaire 1-month	10.8 score on a scale Interval 10.1 to 11.6	10.3 score on a scale Interval 9.6 to 10.9
Measures of Functional Independence as Assessed by the Instrumental Activities of Daily Living (IADL) Questionnaire 3-months	9.5 score on a scale Interval 8.8 to 10.1	8.9 score on a scale Interval 8.5 to 9.4
Measures of Functional Independence as Assessed by the Instrumental Activities of Daily Living (IADL) Questionnaire 6-months	8.6 score on a scale Interval 8.3 to 9.0	8.7 score on a scale Interval 8.2 to 9.1

PRIMARY outcome

Timeframe: baseline, 1 month, 3 months, 6 months

Population: Number of participants included was based on the data available at specific time points.

The hand grip strength test is measured in kilograms of pressure using a handheld dynamometer.

Outcome measures

Outcome measures
Measure	Open Radical Cystectomy n=152 Participants Standard of care treatment	Robotic Assisted Radical Cystectomy n=150 Participants Standard of care treatment using the DaVinci robot.
Performance Related Measures of Functional Independence as Assessed by the Hand Grip Strength Test Baseline	37.4 kg Interval 35.3 to 39.5	36.2 kg Interval 34.3 to 38.2
Performance Related Measures of Functional Independence as Assessed by the Hand Grip Strength Test 1-month	34.5 kg Interval 32.4 to 36.6	34.1 kg Interval 31.9 to 36.3
Performance Related Measures of Functional Independence as Assessed by the Hand Grip Strength Test 3-months	35.1 kg Interval 32.8 to 37.3	34.2 kg Interval 31.7 to 36.7
Performance Related Measures of Functional Independence as Assessed by the Hand Grip Strength Test 6-months	36.4 kg Interval 33.7 to 39.1	34.9 kg Interval 32.3 to 37.5

PRIMARY outcome

Timeframe: baseline, 1 month, 3 months, 6 months

Population: Number of participants included was based on the data available at specific time points.

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.

Outcome measures

Outcome measures
Measure	Open Radical Cystectomy n=152 Participants Standard of care treatment	Robotic Assisted Radical Cystectomy n=150 Participants Standard of care treatment using the DaVinci robot.
Performance Related Measures of Functional Independence as Assessed by the Time Up and Go (TUG) Walking Test Baseline	12.5 seconds Interval 11.2 to 13.7	11.7 seconds Interval 10.9 to 12.4
Performance Related Measures of Functional Independence as Assessed by the Time Up and Go (TUG) Walking Test 1-month	13.6 seconds Interval 12.5 to 14.6	13.1 seconds Interval 11.9 to 14.4
Performance Related Measures of Functional Independence as Assessed by the Time Up and Go (TUG) Walking Test 3-months	12.8 seconds Interval 11.5 to 14.1	11.2 seconds Interval 10.5 to 12.0
Performance Related Measures of Functional Independence as Assessed by the Time Up and Go (TUG) Walking Test 6-months	12.2 seconds Interval 10.6 to 13.8	11.2 seconds Interval 10.3 to 12.1

PRIMARY outcome

Timeframe: baseline, 3 months, 6 months

Population: Not all participants completed the questionnaire at the different visits.

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.

Outcome measures

Outcome measures
Measure	Open Radical Cystectomy n=115 Participants Standard of care treatment	Robotic Assisted Radical Cystectomy n=116 Participants Standard of care treatment using the DaVinci robot.
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 Interval 22.3 to 24.6	22.9 score on a scale Interval 21.8 to 24.0
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 Interval 21.6 to 24.0	23.2 score on a scale Interval 22.1 to 24.3
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 Interval 22.7 to 25.0	23.2 score on a scale Interval 22.0 to 24.3
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 Interval 22.2 to 24.8	23.5 score on a scale Interval 22.2 to 24.7
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 Interval 21.3 to 23.9	23.1 score on a scale Interval 21.9 to 24.3
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 Interval 22.1 to 24.6	23.3 score on a scale Interval 22.1 to 24.5
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 Interval 16.5 to 18.8	17.5 score on a scale Interval 16.4 to 18.6
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 Interval 18.8 to 21.0	19.5 score on a scale Interval 18.4 to 20.5
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 Interval 18.9 to 21.2	19.4 score on a scale Interval 18.3 to 20.5
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 Interval 16.7 to 20.1	18.4 score on a scale Interval 16.8 to 20.0
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 Interval 17.6 to 21.0	17.9 score on a scale Interval 16.3 to 19.5
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 Interval 18.0 to 21.4	18.5 score on a scale Interval 16.9 to 20.1
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 Interval 34.2 to 39.2	37.4 score on a scale Interval 35.0 to 39.8
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 Interval 36.0 to 40.5	37.9 score on a scale Interval 35.8 to 40.0
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 Interval 37.1 to 41.6	39.3 score on a scale Interval 37.1 to 41.4
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 Interval 74.3 to 83.5	78.9 score on a scale Interval 74.6 to 83.2
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 Interval 76.3 to 85.2	79.3 score on a scale Interval 75.1 to 83.4
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 Interval 78.8 to 87.6	81.1 score on a scale Interval 77.0 to 85.3
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 Interval 79.5 to 87.4	82.4 score on a scale Interval 78.6 to 86.1
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 Interval 81.8 to 89.9	84.2 score on a scale Interval 80.4 to 88.1
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 Interval 83.5 to 91.4	85.9 score on a scale Interval 82.1 to 89.7
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 Interval 115.0 to 126.8	120.1 score on a scale Interval 114.5 to 125.8
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 Interval 119.3 to 131.1	122.8 score on a scale Interval 117.2 to 128.3
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 Interval 121.7 to 133.3	126.0 score on a scale Interval 120.4 to 131.6

SECONDARY outcome

Timeframe: 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.

Fixed and variable costs associated with the procedure.

Outcome measures

Outcome data not reported

Adverse Events

Open Cystectomy

Serious events: 0 serious events

Other events: 105 other events

Deaths: 0 deaths

Robotic Assisted Radical Cystectomy

Serious events: 0 serious events

Other events: 101 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Dipen Parekh, MD

University of Miami

Phone: 305 243 6591

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Open Cystectomy n=152 participants at risk Open cystectomy performed using an incision made just above or at the level of umbilicus to the pubic symphysis.	Robotic Assisted Radical Cystectomy n=150 participants at risk Robotic assisted Radical Cystectomy (RARC) is accomplished by a robot assisted laparoscopic approach.
Renal and urinary disorders Urinary Tract Infection	25.7% 39/152 • Number of events 39 • 24 month Adverse events (AE) are defined as complications related to the robotic/open cystectomy and/or study procedures as determined by the principal investigator.	35.3% 53/150 • Number of events 53 • 24 month Adverse events (AE) are defined as complications related to the robotic/open cystectomy and/or study procedures as determined by the principal investigator.
Gastrointestinal disorders post operative ileaus	20.4% 31/152 • Number of events 31 • 24 month Adverse events (AE) are defined as complications related to the robotic/open cystectomy and/or study procedures as determined by the principal investigator.	22.0% 33/150 • Number of events 33 • 24 month Adverse events (AE) are defined as complications related to the robotic/open cystectomy and/or study procedures as determined by the principal investigator.
Gastrointestinal disorders Anastomotic bowel leak	0.00% 0/152 • 24 month Adverse events (AE) are defined as complications related to the robotic/open cystectomy and/or study procedures as determined by the principal investigator.	2.0% 3/150 • Number of events 3 • 24 month Adverse events (AE) are defined as complications related to the robotic/open cystectomy and/or study procedures as determined by the principal investigator.
Gastrointestinal disorders Colitis	3.9% 6/152 • Number of events 6 • 24 month Adverse events (AE) are defined as complications related to the robotic/open cystectomy and/or study procedures as determined by the principal investigator.	4.0% 6/150 • Number of events 6 • 24 month Adverse events (AE) are defined as complications related to the robotic/open cystectomy and/or study procedures as determined by the principal investigator.
Gastrointestinal disorders Colonic perforation	0.66% 1/152 • Number of events 1 • 24 month Adverse events (AE) are defined as complications related to the robotic/open cystectomy and/or study procedures as determined by the principal investigator.	0.00% 0/150 • 24 month Adverse events (AE) are defined as complications related to the robotic/open cystectomy and/or study procedures as determined by the principal investigator.
Gastrointestinal disorders Ileal perforation	1.3% 2/152 • Number of events 2 • 24 month Adverse events (AE) are defined as complications related to the robotic/open cystectomy and/or study procedures as determined by the principal investigator.	0.00% 0/150 • 24 month Adverse events (AE) are defined as complications related to the robotic/open cystectomy and/or study procedures as determined by the principal investigator.
Gastrointestinal disorders Small intestinal obstruction	3.3% 5/152 • Number of events 5 • 24 month Adverse events (AE) are defined as complications related to the robotic/open cystectomy and/or study procedures as determined by the principal investigator.	2.7% 4/150 • Number of events 4 • 24 month Adverse events (AE) are defined as complications related to the robotic/open cystectomy and/or study procedures as determined by the principal investigator.
Infections and infestations Sepsis	10.5% 16/152 • Number of events 16 • 24 month Adverse events (AE) are defined as complications related to the robotic/open cystectomy and/or study procedures as determined by the principal investigator.	10.0% 15/150 • Number of events 15 • 24 month Adverse events (AE) are defined as complications related to the robotic/open cystectomy and/or study procedures as determined by the principal investigator.
Infections and infestations Superficial wound infection	11.8% 18/152 • Number of events 18 • 24 month Adverse events (AE) are defined as complications related to the robotic/open cystectomy and/or study procedures as determined by the principal investigator.	7.3% 11/150 • Number of events 11 • 24 month Adverse events (AE) are defined as complications related to the robotic/open cystectomy and/or study procedures as determined by the principal investigator.
Infections and infestations Deep wound infection	6.6% 10/152 • Number of events 10 • 24 month Adverse events (AE) are defined as complications related to the robotic/open cystectomy and/or study procedures as determined by the principal investigator.	2.0% 3/150 • Number of events 3 • 24 month Adverse events (AE) are defined as complications related to the robotic/open cystectomy and/or study procedures as determined by the principal investigator.
Infections and infestations Intra-abdominal infection	2.0% 3/152 • Number of events 3 • 24 month Adverse events (AE) are defined as complications related to the robotic/open cystectomy and/or study procedures as determined by the principal investigator.	4.7% 7/150 • Number of events 7 • 24 month Adverse events (AE) are defined as complications related to the robotic/open cystectomy and/or study procedures as determined by the principal investigator.
Infections and infestations Stoma site infection	2.0% 3/152 • Number of events 3 • 24 month Adverse events (AE) are defined as complications related to the robotic/open cystectomy and/or study procedures as determined by the principal investigator.	1.3% 2/150 • Number of events 2 • 24 month Adverse events (AE) are defined as complications related to the robotic/open cystectomy and/or study procedures as determined by the principal investigator.
Renal and urinary disorders Acute renal failure	12.5% 19/152 • Number of events 19 • 24 month Adverse events (AE) are defined as complications related to the robotic/open cystectomy and/or study procedures as determined by the principal investigator.	11.3% 17/150 • Number of events 17 • 24 month Adverse events (AE) are defined as complications related to the robotic/open cystectomy and/or study procedures as determined by the principal investigator.
Renal and urinary disorders Renal insufficiency requiring dialysis	0.66% 1/152 • Number of events 1 • 24 month Adverse events (AE) are defined as complications related to the robotic/open cystectomy and/or study procedures as determined by the principal investigator.	0.00% 0/150 • 24 month Adverse events (AE) are defined as complications related to the robotic/open cystectomy and/or study procedures as determined by the principal investigator.
Renal and urinary disorders Urinary Fistula	1.3% 2/152 • Number of events 2 • 24 month Adverse events (AE) are defined as complications related to the robotic/open cystectomy and/or study procedures as determined by the principal investigator.	2.0% 3/150 • Number of events 3 • 24 month Adverse events (AE) are defined as complications related to the robotic/open cystectomy and/or study procedures as determined by the principal investigator.
Renal and urinary disorders Ureteral Stricture	6.6% 10/152 • Number of events 10 • 24 month Adverse events (AE) are defined as complications related to the robotic/open cystectomy and/or study procedures as determined by the principal investigator.	8.7% 13/150 • Number of events 13 • 24 month Adverse events (AE) are defined as complications related to the robotic/open cystectomy and/or study procedures as determined by the principal investigator.
Injury, poisoning and procedural complications Intestinal stoma leak	0.00% 0/152 • 24 month Adverse events (AE) are defined as complications related to the robotic/open cystectomy and/or study procedures as determined by the principal investigator.	0.67% 1/150 • Number of events 1 • 24 month Adverse events (AE) are defined as complications related to the robotic/open cystectomy and/or study procedures as determined by the principal investigator.
Injury, poisoning and procedural complications Intraoperative gastrointestinal injury	0.66% 1/152 • Number of events 1 • 24 month Adverse events (AE) are defined as complications related to the robotic/open cystectomy and/or study procedures as determined by the principal investigator.	0.67% 1/150 • Number of events 1 • 24 month Adverse events (AE) are defined as complications related to the robotic/open cystectomy and/or study procedures as determined by the principal investigator.
Injury, poisoning and procedural complications Seroma	0.00% 0/152 • 24 month Adverse events (AE) are defined as complications related to the robotic/open cystectomy and/or study procedures as determined by the principal investigator.	2.0% 3/150 • Number of events 3 • 24 month Adverse events (AE) are defined as complications related to the robotic/open cystectomy and/or study procedures as determined by the principal investigator.
Injury, poisoning and procedural complications Ureteric anastomotic leak	3.3% 5/152 • Number of events 5 • 24 month Adverse events (AE) are defined as complications related to the robotic/open cystectomy and/or study procedures as determined by the principal investigator.	2.0% 3/150 • Number of events 3 • 24 month Adverse events (AE) are defined as complications related to the robotic/open cystectomy and/or study procedures as determined by the principal investigator.
Injury, poisoning and procedural complications Wound dehiscence	2.0% 3/152 • Number of events 3 • 24 month Adverse events (AE) are defined as complications related to the robotic/open cystectomy and/or study procedures as determined by the principal investigator.	0.00% 0/150 • 24 month Adverse events (AE) are defined as complications related to the robotic/open cystectomy and/or study procedures as determined by the principal investigator.
Injury, poisoning and procedural complications Wound disruption	7.2% 11/152 • Number of events 11 • 24 month Adverse events (AE) are defined as complications related to the robotic/open cystectomy and/or study procedures as determined by the principal investigator.	4.7% 7/150 • Number of events 7 • 24 month Adverse events (AE) are defined as complications related to the robotic/open cystectomy and/or study procedures as determined by the principal investigator.
Respiratory, thoracic and mediastinal disorders Pneumonia	3.9% 6/152 • Number of events 6 • 24 month Adverse events (AE) are defined as complications related to the robotic/open cystectomy and/or study procedures as determined by the principal investigator.	4.7% 7/150 • Number of events 7 • 24 month Adverse events (AE) are defined as complications related to the robotic/open cystectomy and/or study procedures as determined by the principal investigator.
Respiratory, thoracic and mediastinal disorders Aspiration	0.00% 0/152 • 24 month Adverse events (AE) are defined as complications related to the robotic/open cystectomy and/or study procedures as determined by the principal investigator.	1.3% 2/150 • Number of events 2 • 24 month Adverse events (AE) are defined as complications related to the robotic/open cystectomy and/or study procedures as determined by the principal investigator.
Respiratory, thoracic and mediastinal disorders Failure to wean from vent within 48 hours of surgery	0.66% 1/152 • Number of events 1 • 24 month Adverse events (AE) are defined as complications related to the robotic/open cystectomy and/or study procedures as determined by the principal investigator.	0.67% 1/150 • Number of events 1 • 24 month Adverse events (AE) are defined as complications related to the robotic/open cystectomy and/or study procedures as determined by the principal investigator.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.66% 1/152 • Number of events 1 • 24 month Adverse events (AE) are defined as complications related to the robotic/open cystectomy and/or study procedures as determined by the principal investigator.	1.3% 2/150 • Number of events 2 • 24 month Adverse events (AE) are defined as complications related to the robotic/open cystectomy and/or study procedures as determined by the principal investigator.
Respiratory, thoracic and mediastinal disorders Re-intubation	2.6% 4/152 • Number of events 4 • 24 month Adverse events (AE) are defined as complications related to the robotic/open cystectomy and/or study procedures as determined by the principal investigator.	3.3% 5/150 • Number of events 5 • 24 month Adverse events (AE) are defined as complications related to the robotic/open cystectomy and/or study procedures as determined by the principal investigator.
Respiratory, thoracic and mediastinal disorders Pulmonary edema	0.00% 0/152 • 24 month Adverse events (AE) are defined as complications related to the robotic/open cystectomy and/or study procedures as determined by the principal investigator.	0.67% 1/150 • Number of events 1 • 24 month Adverse events (AE) are defined as complications related to the robotic/open cystectomy and/or study procedures as determined by the principal investigator.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.66% 1/152 • Number of events 1 • 24 month Adverse events (AE) are defined as complications related to the robotic/open cystectomy and/or study procedures as determined by the principal investigator.	0.67% 1/150 • Number of events 1 • 24 month Adverse events (AE) are defined as complications related to the robotic/open cystectomy and/or study procedures as determined by the principal investigator.
Vascular disorders Lymphocele	2.0% 3/152 • Number of events 3 • 24 month Adverse events (AE) are defined as complications related to the robotic/open cystectomy and/or study procedures as determined by the principal investigator.	2.7% 4/150 • Number of events 4 • 24 month Adverse events (AE) are defined as complications related to the robotic/open cystectomy and/or study procedures as determined by the principal investigator.
Vascular disorders Pulmonary embolism	2.6% 4/152 • Number of events 4 • 24 month Adverse events (AE) are defined as complications related to the robotic/open cystectomy and/or study procedures as determined by the principal investigator.	2.7% 4/150 • Number of events 4 • 24 month Adverse events (AE) are defined as complications related to the robotic/open cystectomy and/or study procedures as determined by the principal investigator.
Vascular disorders Thromboembolic event	7.9% 12/152 • Number of events 12 • 24 month Adverse events (AE) are defined as complications related to the robotic/open cystectomy and/or study procedures as determined by the principal investigator.	4.7% 7/150 • Number of events 7 • 24 month Adverse events (AE) are defined as complications related to the robotic/open cystectomy and/or study procedures as determined by the principal investigator.
Cardiac disorders Acute coronary syndrome	2.6% 4/152 • Number of events 4 • 24 month Adverse events (AE) are defined as complications related to the robotic/open cystectomy and/or study procedures as determined by the principal investigator.	0.67% 1/150 • Number of events 1 • 24 month Adverse events (AE) are defined as complications related to the robotic/open cystectomy and/or study procedures as determined by the principal investigator.
Cardiac disorders Atrial fibrillation	3.9% 6/152 • Number of events 6 • 24 month Adverse events (AE) are defined as complications related to the robotic/open cystectomy and/or study procedures as determined by the principal investigator.	4.7% 7/150 • Number of events 7 • 24 month Adverse events (AE) are defined as complications related to the robotic/open cystectomy and/or study procedures as determined by the principal investigator.
Cardiac disorders Atrial flutter	0.00% 0/152 • 24 month Adverse events (AE) are defined as complications related to the robotic/open cystectomy and/or study procedures as determined by the principal investigator.	1.3% 2/150 • Number of events 2 • 24 month Adverse events (AE) are defined as complications related to the robotic/open cystectomy and/or study procedures as determined by the principal investigator.
Cardiac disorders Cardiac event with cardiopulmonary resuscitation	0.66% 1/152 • Number of events 1 • 24 month Adverse events (AE) are defined as complications related to the robotic/open cystectomy and/or study procedures as determined by the principal investigator.	0.67% 1/150 • Number of events 1 • 24 month Adverse events (AE) are defined as complications related to the robotic/open cystectomy and/or study procedures as determined by the principal investigator.
Cardiac disorders Myocardial infarction	0.66% 1/152 • Number of events 1 • 24 month Adverse events (AE) are defined as complications related to the robotic/open cystectomy and/or study procedures as determined by the principal investigator.	2.0% 3/150 • Number of events 3 • 24 month Adverse events (AE) are defined as complications related to the robotic/open cystectomy and/or study procedures as determined by the principal investigator.
Cardiac disorders Sick sinus syndrome	0.66% 1/152 • Number of events 1 • 24 month Adverse events (AE) are defined as complications related to the robotic/open cystectomy and/or study procedures as determined by the principal investigator.	0.00% 0/150 • 24 month Adverse events (AE) are defined as complications related to the robotic/open cystectomy and/or study procedures as determined by the principal investigator.
Cardiac disorders Ventricular tachycardia	1.3% 2/152 • Number of events 2 • 24 month Adverse events (AE) are defined as complications related to the robotic/open cystectomy and/or study procedures as determined by the principal investigator.	0.67% 1/150 • Number of events 1 • 24 month Adverse events (AE) are defined as complications related to the robotic/open cystectomy and/or study procedures as determined by the principal investigator.