Open Vs Robotic-Assisted Radical Cystectomy: A Randomized Trial

• Sponsor: University of Miami (Other)
• Overall Status: Completed
• CT.gov ID: NCT01157676
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 350
• Locations: 16
• Arms: 2
• Duration (Months): 89
• Patients Per Site: 21.9
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

This is a multi-institutional, randomized trial evaluating oncologic, perioperative, and functional outcomes following two standard care procedures for radical cystectomy. The participants will have one of the standard care procedures as part of their care. The two procedures that will be followed are open radical cystectomy and robotic assisted radical cystectomy (RARC). Open cystectomy is considered to be the more traditional approach. While newer, RARC is considered to be equivalent to open surgery when it is performed by a trained robotics surgeon. The reported complication rates of RARC appear comparable to open surgery. This means there is no significant difference in the risk between the two standard procedures. However, despite these potential advantages, true comparison between the open and robotic technique with regards to long term cancer related and functional outcomes has not been accomplished because previous studies did not compare patients of equal health status. The researchers hope to learn whether or not patients undergoing RARC recover more quickly than or at the same rate as patients undergoing an open radical cystectomy while having non inferior cancer related outcomes. This study is funded by the National Institutes of Health (NIH).

Condition or Disease	Intervention/Treatment	Phase
Bladder Cancer Requiring Cystectomy	Procedure: Open radical cystectomy; Procedure: Robotic assisted radical cystectomy; Device: DaVinci robot	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 350 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Non inferiority phase 3 randomized clinical trial comparing robotic to open radical cystectomyNon inferiority phase 3 randomized clinical trial comparing robotic to open radical cystectomy
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Open Vs Robotic-Assisted Radical Cystectomy: A Randomized Trial
• Study Start Date: Jul 1, 2011
• Actual Primary Completion Date: Dec 1, 2018
• Actual Study Completion Date: Dec 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Open cystectomy Open cystectomy performed using an incision made just above or at the level of umbilicus to the pubic symphysis.	Procedure: Open radical cystectomy; Standard of care removal of urinary bladder.
Active Comparator: Robotic assisted radical cystectomy Robotic assisted Radical Cystectomy (RARC) is accomplished by a robot assisted laparoscopic approach.	Procedure: Robotic assisted radical cystectomy; Standard of care removal of urinary bladder using DaVinci robot.; Device: DaVinci robot; DaVinci robotic surgical system.

Outcome Measures

Primary Outcome Measures

1. Percentage of Participants With 2-year Progression Free Survival (PFS) [24 months]

   Progression will be determined by the treating physician using the Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 criteria based on radiographic or pathological evidence of disease progression or death from disease.

2. Number of Participants With Positive Margins [At time of cystectomy, approximately 1 hour.]

   Evaluated are the number of participants with positive surgical, bladder, and urethral margins. Positive margin is defined as presence of tumor cells at the edge of the dissected tissue.

3. Number of Participants Requiring Lymph Node Dissection [At time of cystectomy, approximately 1 hour]

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

4. Quality of Life (QOL) Outcomes [at baseline, 3 month, and 6 months]

   Functional Assessment of Cancer Therapy- Vanderbilt Cystectomy Index (FACT-VCI) scores range is 0-168 which is sum of physical, emotional, wellbeing, and FACTS Bl Cys. higher scores=better QOL.

5. Number of Participants With Post-surgical Complications [90 days post operative]

   Post surgical complications will be evaluated using the Clavien grading system with scores ranging from 0-5 with the higher number indicating increased post-surgical complications.

6. Amount of Estimated Blood Loss (EBL) in ml [At time of cystectomy, approximately 1 hour]

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

7. Number of Participants Requiring Blood Transfusion [At time of cystectomy, approximately 1 hour]

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

8. Number of Days of Post Operative Length of Hospital Stay [Day 10 post surgery]

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

9. Length of Operative Time [At time of cystectomy, approximately 1 hour]

   Length of minutes of cystectomy procedure

10. Laboratory Values [baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months, 36 months]

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

11. Measures of Functional Independence as Assessed by the Activities of Daily Living (ADL) Questionnaire [baseline, 1 month , 3 months, 6 months]

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

12. Percentage of Participants With 3-year Progression Free Survival (PFS) [3 years]

    Progression will be determined by the treating physician using the RECIST Version 1.1 criteria based on radiographic or pathological evidence of disease progression or death from disease.

13. Quality of Life (QOL) Outcomes as Assessed by the Short Form 8 (SF-8) Questionnaire [baseline, 3 month, and 6 month]

    The SF-8 consists of two component summary scores; physical (PCS) and mental component summary (MCS). They are scored by weighting each score to a norm-based scoring model. The total scores will be reported as a percentile with higher score indicating better quality of health.

14. Total Number of Participants Requiring Intra-operative Fluid Requirement [At time of cystectomy, approximately 1 hour]

    Total number of participants requiring Intra-operative fluid requirement. (blood+plasma+platelets) Note: In robotic group 1 participant received both plasma and platelets and 1 other received platelets in addition to blood transfusion. In the open group 5 participants received plasma in addition to blood transfusion.

15. Total Postoperative Analgesic Requirements [At time of cystectomy, approximately 1 hour]

    Total postoperative analgesic requirements in milli grams

16. Creatinine Value. [baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months, 36 months]

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

17. Measures of Functional Independence as Assessed by the Instrumental Activities of Daily Living (IADL) Questionnaire [baseline, 1 month, 3 months, 6 months]

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

18. Performance Related Measures of Functional Independence as Assessed by the Hand Grip Strength Test [baseline, 1 month, 3 months, 6 months]

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

19. Performance Related Measures of Functional Independence as Assessed by the Time Up and Go (TUG) Walking Test [baseline, 1 month, 3 months, 6 months]

    The TUG test is measured in seconds. Patients will be timed as they rise from a standard chair, walk 3 meters, turn, walk back, and sit again.

20. Quality of Life (QOL) Outcomes as Assessed by the Functional Assessment of Cancer Therapy - Vanderbilt Cystectomy Index (FACT-VCI) Questionnaire [baseline, 3 months, 6 months]

    FACT-VCI consists of eight domains: Five subscale scores (physical wellbeing, social wellbeing, emotional wellbeing, functional wellbeing, and FACT for patients with Bladder Cancer following Cystectomy [FACT-BL-Cys]) and three derived scores (trial outcome index), FACT-General form (FACT-G), and FACT-BL-Cys Total.The ranges of scores for each domain are as follows: 0-28 for physical, social, and functional wellbeing; 0-24 for emotional wellbeing; 0-60 for FACT-BL-Cys; 0-116 for FACT-VCI Trial Outcome Index (sum of physical wellbeing, functional wellbeing, and FACT-BL-Cys scores); 0-108 for FACT-G (sum of physical, social, emotional, and functional wellbeing scores); and 0-168 for FACT-BL-Cys Total (sum of physical, social, emotional, and functional wellbeing scores, and FACT-BL-Cys).The higher score indicates increased wellbeing.

Secondary Outcome Measures

1. Cost [Day 7]

   Fixed and variable costs associated with the procedure.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Patient must have biopsy proven bladder cancer. Official pathology report reviewed at the participating institution is required.

2. Bladder cancer must be clinical stage T1-T4, N0-1, M0. (AJCC 7th edition) or refractory cis (carcinoma in situ).

Exclusion Criteria:

1. Inability to give informed consent.

2. Prior major abdominal and pelvic open surgical procedures that would preclude a safe robotic approach, as determined by the treating surgeon.

3. At the discretion of the treating surgeon, any pre-existing condition such as severe chronic obstructive pulmonary disease that precludes a safe initiation or maintenance of pneumoperitoneum over a prolonged period of time and during surgery.

4. Age <18 or >99 years.

5. Pregnancy.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic Arizona	Phoenix	Arizona	United States	85054
2	University of California, Irvine Medical Center (UC Irvine)	Orange	California	United States	92868
3	Stanford University	Stanford	California	United States	94305
4	University of Miami	Miami	Florida	United States	33136
5	University of Chicago Medical Center	Chicago	Illinois	United States	60637
6	Loyola University Medical Center	Maywood	Illinois	United States	60153
7	Brigham and Women's Hospital	Boston	Massachusetts	United States	02115
8	University of Michigan Health System	Ann Arbor	Michigan	United States	48109
9	University of Minnesota	Minneapolis	Minnesota	United States	55455
10	Mayo Clinic	Rochester	Minnesota	United States	55905
11	University of North Carolina	Chapel Hill	North Carolina	United States	27599
12	Ohio State University Medical Center	Columbus	Ohio	United States	43210
13	Vanderbilt University Medical Center	Nashville	Tennessee	United States	37232
14	The University of Texas Health Science Center at San Antonio, Medical Arts & Research Center	San Antonio	Texas	United States	78229
15	University of Virginia Health Science Center, Department of Urology	Charlottesville	Virginia	United States	22908
16	Cancer Research and Biostatistics (Data Management and Statistical Office)	Seattle	Washington	United States	98101

Sponsors and Collaborators

• University of Miami
• National Cancer Institute (NCI)

Investigators

• Principal Investigator: Dipen J Parekh, MD, University of Miami

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Mar 6, 2014

More Information

Publications

None provided.

• Responsible Party: Dipen J Parekh, MD, Chairman of Urology, University of Miami
• ClinicalTrials.gov Identifier: NCT01157676
• Other Study ID Numbers: 20120408; R01CA155388; 36911
• First Posted: Jul 7, 2010
• Last Update Posted: Nov 3, 2020
• Last Verified: Oct 1, 2020

• Keywords provided by Dipen J Parekh, MD, Chairman of Urology, University of Miami: open cystectomy; robotic assisted radical cystectomy; bladder cancer
• Additional relevant MeSH terms: Urinary Bladder Neoplasms

Study Results

Participant Flow

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: Enrollment
STARTED	174	176
COMPLETED	153	159
NOT COMPLETED	21	17
Period Title: Enrollment
STARTED	153	159
COMPLETED	152	150
NOT COMPLETED	1	9

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 Participants	152	150	302
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	67	70	68
Sex: Female, Male (Count of Participants)
Female	24 15.8%	24 16%	48 15.9%
Male	128 84.2%	126 84%	254 84.1%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	11 7.2%	12 8%	23 7.6%
Not Hispanic or Latino	138 90.8%	135 90%	273 90.4%
Unknown or Not Reported	3 2%	3 2%	6 2%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	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%
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%	1 0.7%	1 0.3%
Unknown or Not Reported	2 1.3%	3 2%	5 1.7%

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.
Measure Participants	152	150
Median (95% Confidence Interval) [percentage of participants]	71.6 47.1%	72.3 48.2%

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
Measure Participants	152	150
Positive surgical margins	7 4.6%	9 6%
Positive bladder margins	5 3.3%	6 4%
Positive urethral margin	4 2.6%	3 2%

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
Measure Participants	152	149
Extended Lymph Node Dissection	84 55.3%	76 50.7%
Standard Lymph Node Dissection	68 44.7%	73 48.7%

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
Measure Participants	111	108
Baseline Visit	120.9	120.1
3 Month Visit	125.2	122.8
6 Month Visit	127.5	126.0

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
Measure Participants	152	150
Clavien grade 0	47 30.9%	49 32.7%
Clavien grade I	20 13.2%	24 16%
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%
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
Measure Participants	149	148
Mean (95% Confidence Interval) [ml]	700	300

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
Measure Participants	143	143
Perioperative transfusion	65 42.8%	35 23.3%
Intraoperative transfusion	46 30.3%	18 12%
Postoperative transfusion	54 35.5%	33 22%

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
Measure Participants	146	139
Mean (95% Confidence Interval) [days]	7	6

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
Measure Participants	146	139
Mean (95% Confidence Interval) [minutes]	361	428

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.
Measure Participants	152	150
Baseline (Hb)	12.84 (1.87)	13.11 (1.84)
6-weeks (Hb)	11.19 (1.58)	11.62 (1.72)
3-months (Hb)	12.05 (1.81)	12.17 (2.06)
6-months (Hb)	12.73 (2.06)	12.54 (1.89)
12-months (Hb)	12.95 (2.48)	13.25 (2.11)
24-months (Hb)	13.47 (1.89)	13.65 (2.03)
36-months (Hb)	14.14 (1.52)	13.64 (2.59)
Baseline (Albumin)	3.97 (0.71)	4.00 (0.55)
6-weeks (Albumin)	3.66 (0.62)	3.70 (0.62)
3-months (Albumin)	3.88 (0.59)	3.92 (0.60)
6-months (Albumin)	4.02 (0.43)	4.04 (0.40)
12-months (Albumin)	3.96 (0.93)	4.04 (0.46)
24-months (Albumin)	4.00 (0.46)	3.91 (0.75)
36-months (Albumin)	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.
Measure Participants	152	150
Baseline	7.2	7.2
1-month	7.8	7.6
3-months	7.5	7.3
6-months	7.1	7.2

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.
Measure Participants	152	150
Number (95% Confidence Interval) [Percent of participants]	65.4 43%	68.4 45.6%

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.
Measure Participants	152	150
Baseline (PCS)	45.3	46.1
3-months (PCS)	46.2	45.7
6-months(PCS)	49.6	47.5
Baseline (MCS)	48.1	48.1
3-months (MCS)	50.3	49.1
6-months(MCS)	51.8	49.2

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.
Measure Participants	136	139
Count of Participants [Participants]	46 30.3%	18 12%

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.
Measure Participants	152	150
Mean (Standard Deviation) [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.
Measure Participants	152	150
Baseline	1.17 (0.52)	1.12 (0.50)
6-weeks	1.27 (0.67)	1.28 (0.66)
3-months	1.16 (0.44)	1.26 (0.71)
6-months	1.21 (0.46)	1.28 (0.57)
12-months	1.19 (0.43)	1.25 (0.58)
24-months	1.26 (0.48)	1.25 (0.62)
36-months	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.
Measure Participants	152	150
Baseline	8.8	8.5
1-month	10.8	10.3
3-months	9.5	8.9
6-months	8.6	8.7

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.
Measure Participants	152	150
Baseline	37.4	36.2
1-month	34.5	34.1
3-months	35.1	34.2
6-months	36.4	34.9

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.
Measure Participants	152	150
Baseline	12.5	11.7
1-month	13.6	13.1
3-months	12.8	11.2
6-months	12.2	11.2

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
Measure Participants	115	116
Physical Wellbeing baseline	23.4	22.9
Physical Wellbeing 3 months	22.8	23.2
Physical Wellbeing 6 months	23.9	23.2
Social Wellbeing baseline	23.5	23.5
Social Wellbeing 3 months	22.6	23.1
Social Wellbeing 6 months	23.3	23.3
Emotional Wellbeing baseline	17.7	17.5
Emotional Wellbeing 3 months	19.9	19.5
Emotional Wellbeing 6 months	20.0	19.4
Functional Wellbeing baseline	18.4	18.4
Functional Wellbeing 3 months	19.3	17.9
Functional Wellbeing 6 months	19.7	18.5
FACT-BL-Cys Baseline	36.7	37.4
FACT-BL-Cys 3 months	38.2	37.9
FACT-BL-Cys 6 months	39.4	39.3
Trial outcome index Baseline	78.9	78.9
Trial outcome index 3 months	80.7	79.3
Trial outcome index 6 months	83.2	81.1
FACT-G baseline	83.5	82.4
FACT-G 3 months	85.8	84.2
FACT-G 6 months	87.4	85.9
FACT-BL-Cys Total baseline	120.9	120.1
FACT-BL-Cys Total 3 months	125.2	122.8
FACT-BL-Cys Total 6 months	127.5	126.0

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
Measure Participants	0	0

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 (%)	# Events	Affected / at Risk (%)	# Events
Total	0/152 (0%)		0/150 (0%)
Serious Adverse Events
	Open Cystectomy		Robotic Assisted Radical Cystectomy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/152 (0%)		0/150 (0%)
Other (Not Including Serious) Adverse Events
	Open Cystectomy		Robotic Assisted Radical Cystectomy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	105/152 (69.1%)		101/150 (67.3%)
Cardiac disorders
Acute coronary syndrome	4/152 (2.6%)	4	1/150 (0.7%)	1
Atrial fibrillation	6/152 (3.9%)	6	7/150 (4.7%)	7
Atrial flutter	0/152 (0%)	0	2/150 (1.3%)	2
Cardiac event with cardiopulmonary resuscitation	1/152 (0.7%)	1	1/150 (0.7%)	1
Myocardial infarction	1/152 (0.7%)	1	3/150 (2%)	3
Sick sinus syndrome	1/152 (0.7%)	1	0/150 (0%)	0
Ventricular tachycardia	2/152 (1.3%)	2	1/150 (0.7%)	1
Gastrointestinal disorders
post operative ileaus	31/152 (20.4%)	31	33/150 (22%)	33
Anastomotic bowel leak	0/152 (0%)	0	3/150 (2%)	3
Colitis	6/152 (3.9%)	6	6/150 (4%)	6
Colonic perforation	1/152 (0.7%)	1	0/150 (0%)	0
Ileal perforation	2/152 (1.3%)	2	0/150 (0%)	0
Small intestinal obstruction	5/152 (3.3%)	5	4/150 (2.7%)	4
Infections and infestations
Sepsis	16/152 (10.5%)	16	15/150 (10%)	15
Superficial wound infection	18/152 (11.8%)	18	11/150 (7.3%)	11
Deep wound infection	10/152 (6.6%)	10	3/150 (2%)	3
Intra-abdominal infection	3/152 (2%)	3	7/150 (4.7%)	7
Stoma site infection	3/152 (2%)	3	2/150 (1.3%)	2
Injury, poisoning and procedural complications
Intestinal stoma leak	0/152 (0%)	0	1/150 (0.7%)	1
Intraoperative gastrointestinal injury	1/152 (0.7%)	1	1/150 (0.7%)	1
Seroma	0/152 (0%)	0	3/150 (2%)	3
Ureteric anastomotic leak	5/152 (3.3%)	5	3/150 (2%)	3
Wound dehiscence	3/152 (2%)	3	0/150 (0%)	0
Wound disruption	11/152 (7.2%)	11	7/150 (4.7%)	7
Renal and urinary disorders
Urinary Tract Infection	39/152 (25.7%)	39	53/150 (35.3%)	53
Acute renal failure	19/152 (12.5%)	19	17/150 (11.3%)	17
Renal insufficiency requiring dialysis	1/152 (0.7%)	1	0/150 (0%)	0
Urinary Fistula	2/152 (1.3%)	2	3/150 (2%)	3
Ureteral Stricture	10/152 (6.6%)	10	13/150 (8.7%)	13
Respiratory, thoracic and mediastinal disorders
Pneumonia	6/152 (3.9%)	6	7/150 (4.7%)	7
Aspiration	0/152 (0%)	0	2/150 (1.3%)	2
Failure to wean from vent within 48 hours of surgery	1/152 (0.7%)	1	1/150 (0.7%)	1
Respiratory failure	1/152 (0.7%)	1	2/150 (1.3%)	2
Re-intubation	4/152 (2.6%)	4	5/150 (3.3%)	5
Pulmonary edema	0/152 (0%)	0	1/150 (0.7%)	1
Pleural effusion	1/152 (0.7%)	1	1/150 (0.7%)	1
Vascular disorders
Lymphocele	3/152 (2%)	3	4/150 (2.7%)	4
Pulmonary embolism	4/152 (2.6%)	4	4/150 (2.7%)	4
Thromboembolic event	12/152 (7.9%)	12	7/150 (4.7%)	7

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.