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Open Vs Robotic-Assisted Radical Cystectomy: A Randomized Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01157676
Recruitment Status : Completed
First Posted : July 7, 2010
Results First Posted : January 13, 2020
Last Update Posted : November 3, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Dipen J Parekh, MD, University of Miami

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Bladder Cancer Requiring Cystectomy
Interventions Procedure: Open radical cystectomy
Procedure: Robotic assisted radical cystectomy
Device: DaVinci robot
Enrollment 350
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Open Radical Cystectomy Robotic Assisted Radical Cystectomy
Hide Arm/Group Description Standard of care treatment Standard of care treatment using DaVinci robot
Period Title: Enrollment
Started 174 176
Completed 174 176
Not Completed 0 0
Period Title: Randomization
Started 174 176
Completed 153 159
Not Completed 21 17
Reason Not Completed
Death             1             1
unresectable             2             3
Withdrawal by Subject             17             13
Physician Decision             1             0
Period Title: Surgery
Started 153 159
Completed [1] 152 150 [2]
Not Completed 1 9
Reason Not Completed
underwent open cystectomy             0             4
converted to open procedure             0             5
underwent robotic cystectomy             1             0
[1]
wrong procedure due to screen failure (n=2), failure to notify surgeon of randomization (n=2).
[2]
advanced disease=2, inadequate visualization=1, inability to tolerate position=1, colonic mass=1.
Arm/Group Title Open Cystectomy Robotic Assisted Radical Cystectomy Total
Hide Arm/Group Description Standard of care treatment, open cystectomy Standard of care treatment, robotic assisted radical cystectomy Total of all reporting groups
Overall Number of Baseline Participants 152 150 302
Hide Baseline Analysis Population Description
Data analysis completed for participants who finished the study as per protocol.
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 152 participants 150 participants 302 participants
67
(37 to 85)
70
(43 to 90)
68
(37 to 90)
Sex: Female, Male   [1] [2] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 152 participants 150 participants 302 participants
Female
24
  15.8%
24
  16.0%
48
  15.9%
Male
128
  84.2%
126
  84.0%
254
  84.1%
[1]
Measure Description: Data analysis completed for participants who finished the study as per protocol.
[2]
Measure Analysis Population Description: Data analysis completed for participants who finished the study as per protocol.
Ethnicity (NIH/OMB)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 152 participants 150 participants 302 participants
Hispanic or Latino
11
   7.2%
12
   8.0%
23
   7.6%
Not Hispanic or Latino
138
  90.8%
135
  90.0%
273
  90.4%
Unknown or Not Reported
3
   2.0%
3
   2.0%
6
   2.0%
[1]
Measure Analysis Population Description: Data analysis were completed only for the participants that completed the study.
Race (NIH/OMB)   [1] [2] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 152 participants 150 participants 302 participants
American Indian or Alaska Native
0
   0.0%
1
   0.7%
1
   0.3%
Asian
2
   1.3%
2
   1.3%
4
   1.3%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
6
   3.9%
10
   6.7%
16
   5.3%
White
142
  93.4%
133
  88.7%
275
  91.1%
More than one race
0
   0.0%
1
   0.7%
1
   0.3%
Unknown or Not Reported
2
   1.3%
3
   2.0%
5
   1.7%
[1]
Measure Description: Data analysis completed for participants who finished the study as per protocol.
[2]
Measure Analysis Population Description: Data analysis completed for participants who finished the study as per protocol.
1.Primary Outcome
Title Percentage of Participants With 2-year Progression Free Survival (PFS)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Open Radical Cystectomy Robotic Assisted Radical Cystectomy
Hide Arm/Group Description:
Standard of care treatment
Standard of care treatment using the DaVinci robot.
Overall Number of Participants Analyzed 152 150
Median (95% Confidence Interval)
Unit of Measure: percentage of participants
71.6
(63.6 to 78.2)
72.3
(64.3 to 78.8)
2.Primary Outcome
Title Number of Participants With Positive Margins
Hide Description 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.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Open Radical Cystectomy Robotic Assisted Radical Cystectomy
Hide Arm/Group Description:
Standard of care treatment, open cystectomy
Standard of care treatment, robotic assisted radical cystectomy using the DaVinci robot
Overall Number of Participants Analyzed 152 150
Measure Type: Count of Participants
Unit of Measure: Participants
Positive surgical margins
7
   4.6%
9
   6.0%
Positive bladder margins
5
   3.3%
6
   4.0%
Positive urethral margin
4
   2.6%
3
   2.0%
3.Primary Outcome
Title Number of Participants Requiring Lymph Node Dissection
Hide Description Evaluated are the number of participants requiring extended or standard lymph node dissection
Time Frame At time of cystectomy, approximately 1 hour
Hide Outcome Measure Data
Hide Analysis Population Description
1 participant in the RARC group did not have lymph node dissection.
Arm/Group Title Open Radical Cystectomy Robotic Assisted Radical Cystectomy
Hide Arm/Group Description:
Standard of care treatment, open cystectomy
Standard of care treatment, robotic assisted radical cystectomy using the DaVinci robot
Overall Number of Participants Analyzed 152 149
Measure Type: Count of Participants
Unit of Measure: Participants
Extended Lymph Node Dissection
84
  55.3%
76
  51.0%
Standard Lymph Node Dissection
68
  44.7%
73
  49.0%
4.Primary Outcome
Title Quality of Life (QOL) Outcomes
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Not all enrolled participants completed the QOL questionnaires.
Arm/Group Title Open Radical Cystectomy Robotic Assisted Radical Cystectomy
Hide Arm/Group Description:
Standard of care treatment, open cystectomy
Standard of care treatment, robotic assisted radical cystectomy using the DaVinci robot
Overall Number of Participants Analyzed 111 108
Mean (95% Confidence Interval)
Unit of Measure: score on a scale
Baseline Visit Number Analyzed 111 participants 108 participants
120.9
(115 to 126.8)
120.1
(114.5 to 125.8)
3 Month Visit Number Analyzed 94 participants 97 participants
125.2
(119.3 to 131.1)
122.8
(117.2 to 128.3)
6 Month Visit Number Analyzed 91 participants 95 participants
127.5
(121.7 to 133.3)
126.0
(120.4 to 131.6)
5.Primary Outcome
Title Number of Participants With Post-surgical Complications
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
90 day complication using Clavien Grading system
Arm/Group Title Open Radical Cystectomy Robotic Assisted Radical Cystectomy
Hide Arm/Group Description:
Standard of care treatment, open cystectomy
Standard of care treatment, robotic assisted radical cystectomy using the DaVinci robot
Overall Number of Participants Analyzed 152 150
Measure Type: Count of Participants
Unit of Measure: Participants
Clavien grade 0
47
  30.9%
49
  32.7%
Clavien grade I
20
  13.2%
24
  16.0%
Clavien grade II
51
  33.6%
44
  29.3%
Clavien grade III
28
  18.4%
29
  19.3%
Clavien grade IV
2
   1.3%
0
   0.0%
Clavien grade V
4
   2.6%
4
   2.7%
6.Primary Outcome
Title Amount of Estimated Blood Loss (EBL) in ml
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
EBL data was not available on 3 of the open radical cystectomy and 2 of the RARC participants.
Arm/Group Title Open Radical Cystectomy Robotic Assisted Radical Cystectomy
Hide Arm/Group Description:
Standard of care treatment, open cystectomy
Standard of care treatment, robotic assisted radical cystectomy using the DaVinci robot
Overall Number of Participants Analyzed 149 148
Mean (95% Confidence Interval)
Unit of Measure: ml
700
(500 to 1000)
300
(200 to 500)
7.Primary Outcome
Title Number of Participants Requiring Blood Transfusion
Hide Description Number of participants requiring peri, intra, and post operative blood transfusion.
Time Frame At time of cystectomy, approximately 1 hour
Hide Outcome Measure Data
Hide Analysis Population Description
Not all participants in the study required blood transfusion and not all blood transfusion data was available.
Arm/Group Title Open Radical Cystectomy Robotic Assisted Radical Cystectomy
Hide Arm/Group Description:
Standard of care treatment, open cystectomy
Standard of care treatment, robotic assisted radical cystectomy using DaVinci robot
Overall Number of Participants Analyzed 143 143
Measure Type: Count of Participants
Unit of Measure: Participants
Perioperative transfusion Number Analyzed 143 participants 143 participants
65
  45.5%
35
  24.5%
Intraoperative transfusion Number Analyzed 136 participants 139 participants
46
  33.8%
18
  12.9%
Postoperative transfusion Number Analyzed 135 participants 132 participants
54
  40.0%
33
  25.0%
8.Primary Outcome
Title Number of Days of Post Operative Length of Hospital Stay
Hide Description Number of days of post operative length of hospital stay will be evaluated
Time Frame Day 10 post surgery
Hide Outcome Measure Data
Hide Analysis Population Description
Not all length of stay data is available for all the study participants.
Arm/Group Title Open Radical Cystectomy Robotic Assisted Radical Cystectomy
Hide Arm/Group Description:
Standard of care treatment, open cystectomy
Standard of care treatment, robotic assisted radical cystectomy using the DaVinci robot
Overall Number of Participants Analyzed 146 139
Mean (95% Confidence Interval)
Unit of Measure: days
7
(6 to 10)
6
(5 to 10)
9.Primary Outcome
Title Length of Operative Time
Hide Description Length of minutes of cystectomy procedure
Time Frame At time of cystectomy, approximately 1 hour
Hide Outcome Measure Data
Hide Analysis Population Description
The length of operative time is not available for all participants.
Arm/Group Title Open Radical Cystectomy Robotic Assisted Radical Cystectomy
Hide Arm/Group Description:
Standard of care treatment, open cystectomy
Standard of care treatment, robotic assisted radical cystectomy using the DaVinci robot
Overall Number of Participants Analyzed 146 139
Mean (95% Confidence Interval)
Unit of Measure: minutes
361
(281 to 450)
428
(322 to 509)
10.Primary Outcome
Title Laboratory Values
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants included was based on the data available at specific time points.
Arm/Group Title Open Radical Cystectomy Robotic Assisted Radical Cystectomy
Hide Arm/Group Description:
Standard of care treatment
Standard of care treatment using the DaVinci robot.
Overall Number of Participants Analyzed 152 150
Mean (Standard Deviation)
Unit of Measure: g/dL
Baseline (Hb) Number Analyzed 150 participants 148 participants
12.84  (1.87) 13.11  (1.84)
6-weeks (Hb) Number Analyzed 118 participants 110 participants
11.19  (1.58) 11.62  (1.72)
3-months (Hb) Number Analyzed 112 participants 108 participants
12.05  (1.81) 12.17  (2.06)
6-months (Hb) Number Analyzed 97 participants 105 participants
12.73  (2.06) 12.54  (1.89)
12-months (Hb) Number Analyzed 81 participants 87 participants
12.95  (2.48) 13.25  (2.11)
24-months (Hb) Number Analyzed 68 participants 73 participants
13.47  (1.89) 13.65  (2.03)
36-months (Hb) Number Analyzed 52 participants 50 participants
14.14  (1.52) 13.64  (2.59)
Baseline (Albumin) Number Analyzed 117 participants 123 participants
3.97  (0.71) 4.00  (0.55)
6-weeks (Albumin) Number Analyzed 98 participants 88 participants
3.66  (0.62) 3.70  (0.62)
3-months (Albumin) Number Analyzed 97 participants 90 participants
3.88  (0.59) 3.92  (0.60)
6-months (Albumin) Number Analyzed 90 participants 91 participants
4.02  (0.43) 4.04  (0.40)
12-months (Albumin) Number Analyzed 65 participants 75 participants
3.96  (0.93) 4.04  (0.46)
24-months (Albumin) Number Analyzed 58 participants 66 participants
4.00  (0.46) 3.91  (0.75)
36-months (Albumin) Number Analyzed 44 participants 42 participants
4.00  (0.44) 3.97  (0.65)
11.Primary Outcome
Title Measures of Functional Independence as Assessed by the Activities of Daily Living (ADL) Questionnaire
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants changes depending on their data availability at different time points.
Arm/Group Title Open Cystectomy Robotic Assisted Radical Cystectomy
Hide Arm/Group Description:

Open cystectomy performed using an incision made just above or at the level of umbilicus to the pubic symphysis.

Open radical cystectomy: Standard of care removal of urinary bladder.

Robotic assisted Radical Cystectomy (RARC) is accomplished by a robot assisted laparoscopic approach.

Robotic assisted radical cystectomy: Standard of care removal of urinary bladder using DaVinci robot.

DaVinci robot: DaVinci robotic surgical system.
Overall Number of Participants Analyzed 152 150
Mean (95% Confidence Interval)
Unit of Measure: score on a scale
Baseline Number Analyzed 138 participants 133 participants
7.2
(7.1 to 7.3)
7.2
(7.0 to 7.4)
1-month Number Analyzed 125 participants 123 participants
7.8
(7.5 to 8.2)
7.6
(7.3 to 7.9)
3-months Number Analyzed 105 participants 109 participants
7.5
(7.1 to 7.8)
7.3
(7.1 to 7.6)
6-months Number Analyzed 103 participants 103 participants
7.1
(7.0 to 7.2)
7.2
(7.0 to 7.4)
12.Primary Outcome
Title Percentage of Participants With 3-year Progression Free Survival (PFS)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Open Cystectomy Robotic Assisted Radical Cystectomy
Hide Arm/Group Description:

Open cystectomy performed using an incision made just above or at the level of umbilicus to the pubic symphysis.

Open radical cystectomy: Standard of care removal of urinary bladder.

Robotic assisted Radical Cystectomy (RARC) is accomplished by a robot assisted laparoscopic approach.

Robotic assisted radical cystectomy: Standard of care removal of urinary bladder using DaVinci robot.

DaVinci robot: DaVinci robotic surgical system.
Overall Number of Participants Analyzed 152 150
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percent of participants
65.4
(56.8 to 72.7)
68.4
(60.1 to 75.3)
13.Primary Outcome
Title Quality of Life (QOL) Outcomes as Assessed by the Short Form 8 (SF-8) Questionnaire
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants changes depending on their data availability at different time points.
Arm/Group Title Open Radical Cystectomy Robotic Assisted Radical Cystectomy
Hide Arm/Group Description:
Standard of care treatment
Standard of care treatment using the DaVinci robot.
Overall Number of Participants Analyzed 152 150
Mean (95% Confidence Interval)
Unit of Measure: percentile
Baseline (PCS) Number Analyzed 109 participants 107 participants
45.3
(43.2 to 47.4)
46.1
(44.1 to 48.0)
3-months (PCS) Number Analyzed 86 participants 93 participants
46.2
(43.8 to 48.5)
45.7
(43.5 to 47.9)
6-months(PCS) Number Analyzed 93 participants 85 participants
49.6
(47.6 to 51.7)
47.5
(45.6 to 49.3)
Baseline (MCS) Number Analyzed 109 participants 107 participants
48.1
(46.1 to 50.0)
48.1
(46.4 to 49.9)
3-months (MCS) Number Analyzed 86 participants 93 participants
50.3
(48.6 to 51.9)
49.1
(47.2 to 51.1)
6-months(MCS) Number Analyzed 93 participants 85 participants
51.8
(50.1 to 53.5)
49.2
(47.2 to 51.3)
14.Primary Outcome
Title Total Number of Participants Requiring Intra-operative Fluid Requirement
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants included was based on the data available at specific time point.
Arm/Group Title Open Radical Cystectomy Robotic Assisted Radical Cystectomy
Hide Arm/Group Description:
Standard of care treatment
Standard of care treatment using the DaVinci robot.
Overall Number of Participants Analyzed 136 139
Measure Type: Count of Participants
Unit of Measure: Participants
46
  33.8%
18
  12.9%
15.Primary Outcome
Title Total Postoperative Analgesic Requirements
Hide Description Total postoperative analgesic requirements in milli grams
Time Frame At time of cystectomy, approximately 1 hour
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Open Radical Cystectomy Robotic Assisted Radical Cystectomy
Hide Arm/Group Description:
Standard of care treatment
Standard of care treatment using the DaVinci robot.
Overall Number of Participants Analyzed 152 150
Mean (Standard Deviation)
Unit of Measure: mg
157.7  (222.2) 167.2  (264.6)
16.Primary Outcome
Title Creatinine Value.
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants included was based on the data available at specific time points.
Arm/Group Title Open Radical Cystectomy Robotic Assisted Radical Cystectomy
Hide Arm/Group Description:
Standard of care treatment
Standard of care treatment using the DaVinci robot.
Overall Number of Participants Analyzed 152 150
Mean (Standard Deviation)
Unit of Measure: mg/dL
Baseline Number Analyzed 147 participants 148 participants
1.17  (0.52) 1.12  (0.50)
6-weeks Number Analyzed 123 participants 114 participants
1.27  (0.67) 1.28  (0.66)
3-months Number Analyzed 118 participants 110 participants
1.16  (0.44) 1.26  (0.71)
6-months Number Analyzed 99 participants 106 participants
1.21  (0.46) 1.28  (0.57)
12-months Number Analyzed 82 participants 91 participants
1.19  (0.43) 1.25  (0.58)
24-months Number Analyzed 77 participants 82 participants
1.26  (0.48) 1.25  (0.62)
36-months Number Analyzed 53 participants 63 participants
1.26  (0.53) 1.21  (0.71)
17.Primary Outcome
Title Measures of Functional Independence as Assessed by the Instrumental Activities of Daily Living (IADL) Questionnaire
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants included was based on the data available at specific time points.
Arm/Group Title Open Radical Cystectomy Robotic Assisted Radical Cystectomy
Hide Arm/Group Description:
Standard of care treatment
Standard of care treatment using the DaVinci robot.
Overall Number of Participants Analyzed 152 150
Mean (95% Confidence Interval)
Unit of Measure: score on a scale
Baseline Number Analyzed 136 participants 132 participants
8.8
(8.4 to 9.2)
8.5
(8.2 to 8.7)
1-month Number Analyzed 122 participants 120 participants
10.8
(10.1 to 11.6)
10.3
(9.6 to 10.9)
3-months Number Analyzed 104 participants 105 participants
9.5
(8.8 to 10.1)
8.9
(8.5 to 9.4)
6-months Number Analyzed 102 participants 101 participants
8.6
(8.3 to 9.0)
8.7
(8.2 to 9.1)
18.Primary Outcome
Title Performance Related Measures of Functional Independence as Assessed by the Hand Grip Strength Test
Hide Description The hand grip strength test is measured in kilograms of pressure using a handheld dynamometer.
Time Frame baseline, 1 month, 3 months, 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants included was based on the data available at specific time points.
Arm/Group Title Open Radical Cystectomy Robotic Assisted Radical Cystectomy
Hide Arm/Group Description:
Standard of care treatment
Standard of care treatment using the DaVinci robot.
Overall Number of Participants Analyzed 152 150
Mean (95% Confidence Interval)
Unit of Measure: kg
Baseline Number Analyzed 132 participants 127 participants
37.4
(35.3 to 39.5)
36.2
(34.3 to 38.2)
1-month Number Analyzed 112 participants 104 participants
34.5
(32.4 to 36.6)
34.1
(31.9 to 36.3)
3-months Number Analyzed 88 participants 90 participants
35.1
(32.8 to 37.3)
34.2
(31.7 to 36.7)
6-months Number Analyzed 86 participants 86 participants
36.4
(33.7 to 39.1)
34.9
(32.3 to 37.5)
19.Primary Outcome
Title Performance Related Measures of Functional Independence as Assessed by the Time Up and Go (TUG) Walking Test
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants included was based on the data available at specific time points.
Arm/Group Title Open Radical Cystectomy Robotic Assisted Radical Cystectomy
Hide Arm/Group Description:
Standard of care treatment
Standard of care treatment using the DaVinci robot.
Overall Number of Participants Analyzed 152 150
Mean (95% Confidence Interval)
Unit of Measure: seconds
Baseline Number Analyzed 125 participants 122 participants
12.5
(11.2 to 13.7)
11.7
(10.9 to 12.4)
1-month Number Analyzed 102 participants 96 participants
13.6
(12.5 to 14.6)
13.1
(11.9 to 14.4)
3-months Number Analyzed 83 participants 83 participants
12.8
(11.5 to 14.1)
11.2
(10.5 to 12.0)
6-months Number Analyzed 81 participants 81 participants
12.2
(10.6 to 13.8)
11.2
(10.3 to 12.1)
20.Primary Outcome
Title Quality of Life (QOL) Outcomes as Assessed by the Functional Assessment of Cancer Therapy - Vanderbilt Cystectomy Index (FACT-VCI) Questionnaire
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Not all participants completed the questionnaire at the different visits.
Arm/Group Title Open Radical Cystectomy Robotic Assisted Radical Cystectomy
Hide Arm/Group Description:
Standard of care treatment, open cystectomy
Standard of care treatment, robotic assisted radical cystectomy using DaVinci robot
Overall Number of Participants Analyzed 115 116
Mean (95% Confidence Interval)
Unit of Measure: score on a scale
Physical Wellbeing baseline Number Analyzed 115 participants 116 participants
23.4
(22.3 to 24.6)
22.9
(21.8 to 24.0)
Physical Wellbeing 3 months Number Analyzed 102 participants 104 participants
22.8
(21.6 to 24.0)
23.2
(22.1 to 24.3)
Physical Wellbeing 6 months Number Analyzed 99 participants 99 participants
23.9
(22.7 to 25.0)
23.2
(22.0 to 24.3)
Social Wellbeing baseline Number Analyzed 115 participants 113 participants
23.5
(22.2 to 24.8)
23.5
(22.2 to 24.7)
Social Wellbeing 3 months Number Analyzed 100 participants 105 participants
22.6
(21.3 to 23.9)
23.1
(21.9 to 24.3)
Social Wellbeing 6 months Number Analyzed 98 participants 99 participants
23.3
(22.1 to 24.6)
23.3
(22.1 to 24.5)
Emotional Wellbeing baseline Number Analyzed 112 participants 111 participants
17.7
(16.5 to 18.8)
17.5
(16.4 to 18.6)
Emotional Wellbeing 3 months Number Analyzed 95 participants 98 participants
19.9
(18.8 to 21.0)
19.5
(18.4 to 20.5)
Emotional Wellbeing 6 months Number Analyzed 91 participants 96 participants
20.0
(18.9 to 21.2)
19.4
(18.3 to 20.5)
Functional Wellbeing baseline Number Analyzed 115 participants 115 participants
18.4
(16.7 to 20.1)
18.4
(16.8 to 20.0)
Functional Wellbeing 3 months Number Analyzed 100 participants 105 participants
19.3
(17.6 to 21.0)
17.9
(16.3 to 19.5)
Functional Wellbeing 6 months Number Analyzed 97 participants 98 participants
19.7
(18.0 to 21.4)
18.5
(16.9 to 20.1)
FACT-BL-Cys Baseline Number Analyzed 114 participants 115 participants
36.7
(34.2 to 39.2)
37.4
(35.0 to 39.8)
FACT-BL-Cys 3 months Number Analyzed 100 participants 105 participants
38.2
(36.0 to 40.5)
37.9
(35.8 to 40.0)
FACT-BL-Cys 6 months Number Analyzed 97 participants 98 participants
39.4
(37.1 to 41.6)
39.3
(37.1 to 41.4)
Trial outcome index Baseline Number Analyzed 114 participants 115 participants
78.9
(74.3 to 83.5)
78.9
(74.6 to 83.2)
Trial outcome index 3 months Number Analyzed 100 participants 104 participants
80.7
(76.3 to 85.2)
79.3
(75.1 to 83.4)
Trial outcome index 6 months Number Analyzed 97 participants 98 participants
83.2
(78.8 to 87.6)
81.1
(77.0 to 85.3)
FACT-G baseline Number Analyzed 112 participants 108 participants
83.5
(79.5 to 87.4)
82.4
(78.6 to 86.1)
FACT-G 3 months Number Analyzed 94 participants 97 participants
85.8
(81.8 to 89.9)
84.2
(80.4 to 88.1)
FACT-G 6 months Number Analyzed 91 participants 95 participants
87.4
(83.5 to 91.4)
85.9
(82.1 to 89.7)
FACT-BL-Cys Total baseline Number Analyzed 111 participants 108 participants
120.9
(115.0 to 126.8)
120.1
(114.5 to 125.8)
FACT-BL-Cys Total 3 months Number Analyzed 94 participants 97 participants
125.2
(119.3 to 131.1)
122.8
(117.2 to 128.3)
FACT-BL-Cys Total 6 months Number Analyzed 91 participants 95 participants
127.5
(121.7 to 133.3)
126.0
(120.4 to 131.6)
21.Secondary Outcome
Title Cost
Hide Description Fixed and variable costs associated with the procedure.
Time Frame Day 7
Hide Outcome Measure Data
Hide Analysis Population Description
Cost data was specified as a secondary endpoint in the protocol, but data could not be collected from all sites due to proprietary reasons.
Arm/Group Title Open Radical Cystectomy Robotic Assisted Radical Cystectomy
Hide Arm/Group Description:
Standard of care treatment
Standard of care treatment using DaVinci robot
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame 24 month
Adverse Event Reporting Description Adverse events (AE) are defined as complications related to the robotic/open cystectomy and/or study procedures as determined by the principal investigator.
 
Arm/Group Title Open Cystectomy Robotic Assisted Radical Cystectomy
Hide Arm/Group Description Open cystectomy performed using an incision made just above or at the level of umbilicus to the pubic symphysis. Robotic assisted Radical Cystectomy (RARC) is accomplished by a robot assisted laparoscopic approach.
All-Cause Mortality
Open Cystectomy Robotic Assisted Radical Cystectomy
Affected / at Risk (%) Affected / at Risk (%)
Total   0/152 (0.00%)      0/150 (0.00%)    
Hide Serious Adverse Events
Open Cystectomy Robotic Assisted Radical Cystectomy
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/152 (0.00%)      0/150 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Open Cystectomy Robotic Assisted Radical Cystectomy
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   105/152 (69.08%)      101/150 (67.33%)    
Cardiac disorders     
Acute coronary syndrome †  4/152 (2.63%)  4 1/150 (0.67%)  1
Atrial fibrillation †  6/152 (3.95%)  6 7/150 (4.67%)  7
Atrial flutter †  0/152 (0.00%)  0 2/150 (1.33%)  2
Cardiac event with cardiopulmonary resuscitation †  1/152 (0.66%)  1 1/150 (0.67%)  1
Myocardial infarction †  1/152 (0.66%)  1 3/150 (2.00%)  3
Sick sinus syndrome †  1/152 (0.66%)  1 0/150 (0.00%)  0
Ventricular tachycardia †  2/152 (1.32%)  2 1/150 (0.67%)  1
Gastrointestinal disorders     
post operative ileaus †  31/152 (20.39%)  31 33/150 (22.00%)  33
Anastomotic bowel leak †  0/152 (0.00%)  0 3/150 (2.00%)  3
Colitis †  6/152 (3.95%)  6 6/150 (4.00%)  6
Colonic perforation †  1/152 (0.66%)  1 0/150 (0.00%)  0
Ileal perforation †  2/152 (1.32%)  2 0/150 (0.00%)  0
Small intestinal obstruction †  5/152 (3.29%)  5 4/150 (2.67%)  4
Infections and infestations     
Sepsis †  16/152 (10.53%)  16 15/150 (10.00%)  15
Superficial wound infection †  18/152 (11.84%)  18 11/150 (7.33%)  11
Deep wound infection †  10/152 (6.58%)  10 3/150 (2.00%)  3
Intra-abdominal infection †  3/152 (1.97%)  3 7/150 (4.67%)  7
Stoma site infection †  3/152 (1.97%)  3 2/150 (1.33%)  2
Injury, poisoning and procedural complications     
Intestinal stoma leak †  0/152 (0.00%)  0 1/150 (0.67%)  1
Intraoperative gastrointestinal injury †  1/152 (0.66%)  1 1/150 (0.67%)  1
Seroma †  0/152 (0.00%)  0 3/150 (2.00%)  3
Ureteric anastomotic leak †  5/152 (3.29%)  5 3/150 (2.00%)  3
Wound dehiscence †  3/152 (1.97%)  3 0/150 (0.00%)  0
Wound disruption †  11/152 (7.24%)  11 7/150 (4.67%)  7
Renal and urinary disorders     
Urinary Tract Infection †  39/152 (25.66%)  39 53/150 (35.33%)  53
Acute renal failure †  19/152 (12.50%)  19 17/150 (11.33%)  17
Renal insufficiency requiring dialysis †  1/152 (0.66%)  1 0/150 (0.00%)  0
Urinary Fistula †  2/152 (1.32%)  2 3/150 (2.00%)  3
Ureteral Stricture †  10/152 (6.58%)  10 13/150 (8.67%)  13
Respiratory, thoracic and mediastinal disorders     
Pneumonia †  6/152 (3.95%)  6 7/150 (4.67%)  7
Aspiration †  0/152 (0.00%)  0 2/150 (1.33%)  2
Failure to wean from vent within 48 hours of surgery †  1/152 (0.66%)  1 1/150 (0.67%)  1
Respiratory failure †  1/152 (0.66%)  1 2/150 (1.33%)  2
Re-intubation †  4/152 (2.63%)  4 5/150 (3.33%)  5
Pulmonary edema †  0/152 (0.00%)  0 1/150 (0.67%)  1
Pleural effusion †  1/152 (0.66%)  1 1/150 (0.67%)  1
Vascular disorders     
Lymphocele †  3/152 (1.97%)  3 4/150 (2.67%)  4
Pulmonary embolism †  4/152 (2.63%)  4 4/150 (2.67%)  4
Thromboembolic event †  12/152 (7.89%)  12 7/150 (4.67%)  7
†
Indicates events were collected by systematic assessment
[Not Specified]
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dipen Parekh, MD
Organization: University of Miami
Phone: 305 243 6591
EMail: parekhd@miami.med.edu
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Dipen J Parekh, MD, University of Miami
ClinicalTrials.gov Identifier: NCT01157676    
Other Study ID Numbers: 20120408
R01CA155388 ( U.S. NIH Grant/Contract )
36911 ( Other Identifier: Investigator-Assigned ID )
First Submitted: June 30, 2010
First Posted: July 7, 2010
Results First Submitted: February 11, 2019
Results First Posted: January 13, 2020
Last Update Posted: November 3, 2020