Open Vs Robotic-Assisted Radical Cystectomy: A Randomized Trial

Not Applicable

Completed

Conditions: Bladder Cancer Requiring Cystectomy

Interventions: Procedure: Open radical cystectomy
Procedure: Robotic assisted radical cystectomy
Device: DaVinci robot

Registration Number: NCT01157676

Lead Sponsor: University of Miami

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).

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 350

Inclusion Criteria

Patient must have biopsy proven bladder cancer. Official pathology report reviewed at the participating institution is required.
Bladder cancer must be clinical stage T1-T4, N0-1, M0. (AJCC 7th edition) or refractory cis (carcinoma in situ).

Exclusion Criteria

Inability to give informed consent.
Prior major abdominal and pelvic open surgical procedures that would preclude a safe robotic approach, as determined by the treating surgeon.
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.
Age <18 or >99 years.
Pregnancy.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Open cystectomy	Open radical cystectomy	Open cystectomy performed using an incision made just above or at the level of umbilicus to the pubic symphysis.
Robotic assisted radical cystectomy	Robotic assisted radical cystectomy	Robotic assisted Radical Cystectomy (RARC) is accomplished by a robot assisted laparoscopic approach.
Robotic assisted radical cystectomy	DaVinci robot	Robotic assisted Radical Cystectomy (RARC) is accomplished by a robot assisted laparoscopic approach.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With 2-year Progression Free Survival (PFS)	24 months	Progression will be determined by the treating physician using the Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 criteria based on radiographic or pathological evidence of disease progression or death from disease.
Number of Participants With Positive Margins	At time of cystectomy, approximately 1 hour.	Evaluated are the number of participants with positive surgical, bladder, and urethral margins. Positive margin is defined as presence of tumor cells at the edge of the dissected tissue.
Number of Participants Requiring Lymph Node Dissection	At time of cystectomy, approximately 1 hour	Evaluated are the number of participants requiring extended or standard lymph node dissection
Quality of Life (QOL) Outcomes	at baseline, 3 month, and 6 months	Functional Assessment of Cancer Therapy- Vanderbilt Cystectomy Index (FACT-VCI) scores range is 0-168 which is sum of physical, emotional, wellbeing, and FACTS Bl Cys. higher scores=better QOL.
Number of Participants With Post-surgical Complications	90 days post operative	Post surgical complications will be evaluated using the Clavien grading system with scores ranging from 0-5 with the higher number indicating increased post-surgical complications.
Amount of Estimated Blood Loss (EBL) in ml	At time of cystectomy, approximately 1 hour	Perioperative measures such as EBL will be evaluated by measuring the amount of participant blood loss in ml.
Number of Participants Requiring Blood Transfusion	At time of cystectomy, approximately 1 hour	Number of participants requiring peri, intra, and post operative blood transfusion.
Number of Days of Post Operative Length of Hospital Stay	Day 10 post surgery	Number of days of post operative length of hospital stay will be evaluated
Length of Operative Time	At time of cystectomy, approximately 1 hour	Length of minutes of cystectomy procedure
Laboratory Values	baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months, 36 months	Serum Hemoglobin (Hb) and Albumin will be reported in grams per deciliters (g/dL)
Measures of Functional Independence as Assessed by the Activities of Daily Living (ADL) Questionnaire	baseline, 1 month , 3 months, 6 months	Participant reported ADL questionnaire is a 7 item questionnaire with scores ranging from 7-21 with a lower score indicating increased independence.
Percentage of Participants With 3-year Progression Free Survival (PFS)	3 years	Progression will be determined by the treating physician using the RECIST Version 1.1 criteria based on radiographic or pathological evidence of disease progression or death from disease.
Quality of Life (QOL) Outcomes as Assessed by the Short Form 8 (SF-8) Questionnaire	baseline, 3 month, and 6 month	The SF-8 consists of two component summary scores; physical (PCS) and mental component summary (MCS). They are scored by weighting each score to a norm-based scoring model. The total scores will be reported as a percentile with higher score indicating better quality of health.
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).
Total Postoperative Analgesic Requirements	At time of cystectomy, approximately 1 hour	Total postoperative analgesic requirements in milli grams
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.
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.
Measures of Functional Independence as Assessed by the Instrumental Activities of Daily Living (IADL) Questionnaire	baseline, 1 month, 3 months, 6 months	Participant reported IADL questionnaire is an 8 item questionnaire with scores ranging from 8-32 with a lower score indicating increased independence.
Performance Related Measures of Functional Independence as Assessed by the Hand Grip Strength Test	baseline, 1 month, 3 months, 6 months	The hand grip strength test is measured in kilograms of pressure using a handheld dynamometer.
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

Name	Time	Method
Cost	Day 7	Fixed and variable costs associated with the procedure.

Trial Locations

Locations (16): University of Virginia Health Science Center, Department of Urology
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Charlottesville, Virginia, United States
Stanford University
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Stanford, California, United States
University of North Carolina
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Chapel Hill, North Carolina, United States
Mayo Clinic Arizona
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Phoenix, Arizona, United States
University of Miami
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Miami, Florida, United States
University of Chicago Medical Center
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Chicago, Illinois, United States
Loyola University Medical Center
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Maywood, Illinois, United States
University of Michigan Health System
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Ann Arbor, Michigan, United States
University of Minnesota
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Minneapolis, Minnesota, United States
Mayo Clinic
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Rochester, Minnesota, United States
Ohio State University Medical Center
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Columbus, Ohio, United States
Vanderbilt University Medical Center
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Nashville, Tennessee, United States
The University of Texas Health Science Center at San Antonio, Medical Arts & Research Center
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San Antonio, Texas, United States
Cancer Research and Biostatistics (Data Management and Statistical Office)
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Seattle, Washington, United States
University of California, Irvine Medical Center (UC Irvine)
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Orange, California, United States
Brigham and Women's Hospital
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Boston, Massachusetts, United States