Open Vs Robotic-Assisted Radical Cystectomy: A Randomized Trial

• 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: University of Miami
• 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

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Open Radical Cystectomy	Robotic Assisted Radical Cystectomy
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.

Baseline Characteristics

Arm/Group Title		Open Cystectomy	Robotic Assisted Radical Cystectomy	Total
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
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.

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants With 2-year Progression Free Survival (PFS)
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Open Radical Cystectomy	Robotic Assisted Radical Cystectomy
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
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.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Open Radical Cystectomy	Robotic Assisted Radical Cystectomy
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
Description	Evaluated are the number of participants requiring extended or standard lymph node dissection
Time Frame	At time of cystectomy, approximately 1 hour

Outcome Measure Data

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
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
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

Outcome Measure Data

Analysis Population Description

Not all enrolled participants completed the QOL questionnaires.

Arm/Group Title		Open Radical Cystectomy	Robotic Assisted Radical Cystectomy
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
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

Outcome Measure Data

Analysis Population Description

90 day complication using Clavien Grading system

Arm/Group Title	Open Radical Cystectomy	Robotic Assisted Radical Cystectomy
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
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

Outcome Measure Data

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
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
Description	Number of participants requiring peri, intra, and post operative blood transfusion.
Time Frame	At time of cystectomy, approximately 1 hour

Outcome Measure Data

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
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
Description	Number of days of post operative length of hospital stay will be evaluated
Time Frame	Day 10 post surgery

Outcome Measure Data

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
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
Description	Length of minutes of cystectomy procedure
Time Frame	At time of cystectomy, approximately 1 hour

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Open Radical Cystectomy	Robotic Assisted Radical Cystectomy
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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)
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Open Cystectomy	Robotic Assisted Radical Cystectomy
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
Description	Total postoperative analgesic requirements in milli grams
Time Frame	At time of cystectomy, approximately 1 hour

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Open Radical Cystectomy	Robotic Assisted Radical Cystectomy
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.
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

Analysis Population Description

Not all participants completed the questionnaire at the different visits.

Arm/Group Title		Open Radical Cystectomy	Robotic Assisted Radical Cystectomy
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
Description	Fixed and variable costs associated with the procedure.
Time Frame	Day 7

Outcome Measure Data

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
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.

Adverse Events

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
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%)
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%)
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

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact

• 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):

Venkatramani V, Reis IM, Gonzalgo ML, Castle EP, Woods ME, Svatek RS, Weizer AZ, Konety BR, Tollefson M, Krupski TL, Smith ND, Shabsigh A, Barocas DA, Quek ML, Dash A, Parekh DJ. Comparison of Robot-Assisted and Open Radical Cystectomy in Recovery of Patient-Reported and Performance-Related Measures of Independence: A Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2022 Feb 1;5(2):e2148329. doi: 10.1001/jamanetworkopen.2021.48329.

Parekh DJ, Reis IM, Castle EP, Gonzalgo ML, Woods ME, Svatek RS, Weizer AZ, Konety BR, Tollefson M, Krupski TL, Smith ND, Shabsigh A, Barocas DA, Quek ML, Dash A, Kibel AS, Shemanski L, Pruthi RS, Montgomery JS, Weight CJ, Sharp DS, Chang SS, Cookson MS, Gupta GN, Gorbonos A, Uchio EM, Skinner E, Venkatramani V, Soodana-Prakash N, Kendrick K, Smith JA Jr, Thompson IM. Robot-assisted radical cystectomy versus open radical cystectomy in patients with bladder cancer (RAZOR): an open-label, randomised, phase 3, non-inferiority trial. Lancet. 2018 Jun 23;391(10139):2525-2536. doi: 10.1016/S0140-6736(18)30996-6.

• 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