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 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	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• 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 cystectomy
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Open Vs Robotic-Assisted Radical Cystectomy: A Randomized Trial
• Study Start Date: July 2011
• Actual Primary Completion Date: December 2018
• Actual Study Completion Date: December 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) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Day 10 post surgery ]
   Number of days of post operative length of hospital stay will be evaluated
9. Length of Operative Time [ Time Frame: At time of cystectomy, approximately 1 hour ]
   Length of minutes of cystectomy procedure
10. Laboratory Values [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: At time of cystectomy, approximately 1 hour ]
    Total postoperative analgesic requirements in milli grams
16. Creatinine Value. [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Day 7 ]
   Fixed and variable costs associated with the procedure.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

United States, Arizona

Mayo Clinic Arizona

Phoenix, Arizona, United States, 85054

United States, California

University of California, Irvine Medical Center (UC Irvine)

Orange, California, United States, 92868

Stanford University

Stanford, California, United States, 94305

United States, Florida

University of Miami

Miami, Florida, United States, 33136

United States, Illinois

University of Chicago Medical Center

Chicago, Illinois, United States, 60637

Loyola University Medical Center

Maywood, Illinois, United States, 60153

United States, Massachusetts

Brigham and Women's Hospital

Boston, Massachusetts, United States, 02115

United States, Michigan

University of Michigan Health System

Ann Arbor, Michigan, United States, 48109

United States, Minnesota

University of Minnesota

Minneapolis, Minnesota, United States, 55455

Mayo Clinic

Rochester, Minnesota, United States, 55905

United States, North Carolina

University of North Carolina

Chapel Hill, North Carolina, United States, 27599

United States, Ohio

Ohio State University Medical Center

Columbus, Ohio, United States, 43210

United States, Tennessee

Vanderbilt University Medical Center

Nashville, Tennessee, United States, 37232

United States, Texas

The University of Texas Health Science Center at San Antonio, Medical Arts & Research Center

San Antonio, Texas, United States, 78229

United States, Virginia

University of Virginia Health Science Center, Department of Urology

Charlottesville, Virginia, United States, 22908

United States, Washington

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)

Documents provided by Dipen J Parekh, MD, University of Miami:

Study Protocol and Statistical Analysis Plan  [PDF] March 6, 2014

More Information

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, Chairman of Urology, 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 Posted: July 7, 2010
• Results First Posted: January 13, 2020
• Last Update Posted: November 3, 2020
• Last Verified: October 2020

Keywords provided by Dipen J Parekh, MD, University of Miami:

open cystectomy; robotic assisted radical cystectomy; bladder cancer

Additional relevant MeSH terms:

Urinary Bladder Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases