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Urinary Diversion During Robotic Assisted Radical Cystectomy in Patients With Bladder Cancer

Primary Purpose

Recurrent Bladder Cancer, Stage 0 Bladder Cancer, Stage I Bladder Cancer

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
robot-assisted laparoscopic surgery
robot-assisted laparoscopic surgery
intraoperative complication management/prevention
intraoperative complication management/prevention
quality-of-life assessment
Sponsored by
Case Comprehensive Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Recurrent Bladder Cancer

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Grade G1 - G3 bladder cancer
  • T stage: cTis - T2
  • N0
  • M0
  • American Society of Anesthesiologists (ASA) < 4
  • Informed consent
  • Eastern Cooperative Oncology Group (ECOG) performance status 2 or better
  • Hemoglobin (Hgb) > 8.0 g/dL
  • White blood cell (WBC) > 2.0 k/uL
  • Platelets > 50,000
  • Creatinine < 3.0 x upper limit of normal (ULN)
  • Aspartate aminotransferase (AST) < 5.0 x ULN
  • Alanine transaminase (ALT) < 5.0 x ULN

Exclusion Criteria:

  • Patient unsuitable for or refusing radical cystectomy
  • T stage ≥ T3 (mass extending outside the bladder)
  • Gross nodal or metastatic disease at presentation (≥ N1, M1)
  • Prior pelvic radiation
  • Prior open or laparoscopic/robotic bladder or prostate surgery
  • Prior colorectal surgery or history of inflammatory bowel disease
  • Body mass index (BMI) ≥ 40
  • ECOG performance status 3 or worse
  • History of coagulopathy or bleeding disorders
  • Chronic steroid use
  • Patients with end stage renal disease (ESRD) and/or on dialysis

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Arm I (RARC with IUD)

    Arm II (RARC with EUD)

    Arm Description

    Patients undergo RARC with IUD.

    Patients undergo RARC with EUD.

    Outcomes

    Primary Outcome Measures

    Complication rate
    Analyzed using multivariable logistical regression. Descriptions and grading scales found in the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for adverse event reporting.

    Secondary Outcome Measures

    Time to passage of flatus
    Analyzed using regression analysis.
    Analgesic requirement (narcotic use)
    Analyzed using logistical regression.
    Hospital length of stay
    Analyzed using regression analysis.
    Total operating time
    Analyzed using regression analysis.
    Estimated blood loss
    Analyzed using regression analysis.
    Readmission rate
    Analyzed using regression analysis.
    Quality of life assessed using the Bladder Cancer Index Questionnaire
    The Cox proportional hazards model will be used. The hazard ratio (HR) and 95% confidence interval (95% CI) associated with the use of RARC with IUD compared with the use of RARC with EUD will be calculated.
    Ureteral strictures
    The Cox proportional hazards model will be used. The HR and 95% CI associated with the use of RARC with IUD compared with the use of RARC with EUD will be calculated.
    Stromal stenosis
    The Cox proportional hazards model will be used. The HR and 95% CI associated with the use of RARC with IUD compared with the use of RARC with EUD will be calculated.
    Disease recurrence
    The Cox proportional hazards model will be used. The HR and 95% CI associated with the use of RARC with IUD compared with the use of RARC with EUD will be calculated.
    Secondary procedures
    The Cox proportional hazards model will be used. The HR and 95% CI associated with the use of RARC with IUD compared with the use of RARC with EUD will be calculated.
    Cumulative complication incidence
    Graphically described using the Kaplan-Meier method. Descriptions and grading scales found in the NCI CTCAE version 4.0 will be utilized for adverse event reporting.

    Full Information

    First Posted
    September 26, 2014
    Last Updated
    November 8, 2016
    Sponsor
    Case Comprehensive Cancer Center
    Collaborators
    National Cancer Institute (NCI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02252393
    Brief Title
    Urinary Diversion During Robotic Assisted Radical Cystectomy in Patients With Bladder Cancer
    Official Title
    Prospective Randomized Comparison of Intracorporeal Versus Extracorporeal Urinary Diversion During Robotic Radical Cystectomy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2016
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    waiting on surgeon training
    Study Start Date
    October 2015 (undefined)
    Primary Completion Date
    November 2016 (Actual)
    Study Completion Date
    November 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Case Comprehensive Cancer Center
    Collaborators
    National Cancer Institute (NCI)

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This randomized clinical trial studies intracorporeal or extracorporeal urinary diversion during robotic assisted radical cystectomy in reducing complications in patients with bladder cancer. Radical cystectomy is surgery to remove the entire bladder as well as nearby tissues and organs. After the bladder is removed, urinary diversion (a surgical procedure to make a new way for urine to leave the body) is performed. It is not yet known whether intracorporeal (within the body) or extracorporeal (outside of the body) urinary diversion is a better method in patients with bladder cancer undergoing robotic assisted radical cystectomy.
    Detailed Description
    PRIMARY OBJECTIVES: I. To compare perioperative outcomes and complications after robotic assisted radical cystectomy (RARC) with intracorporeal urinary diversion (IUD) and RARC with extracorporeal urinary diversion (EUD) in a prospective randomized fashion. SECONDARY OBJECTIVES: I. Time to passage of flatus. II. Analgesic requirement (narcotic use). III. Hospital length of stay. IV. Total operating time. V. Estimated blood loss. VI. Readmission rate. VII. Bladder Cancer Index Questionnaire. VIII. Ureteral strictures. IX. Stomal stenosis. X. Disease recurrence. XI. Secondary procedures. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients undergo RARC with IUD. ARM II: Patients undergo RARC with EUD. After completion of study treatment, patients are followed up within 90 days and then for 2-5 years.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Recurrent Bladder Cancer, Stage 0 Bladder Cancer, Stage I Bladder Cancer, Stage II Bladder Cancer, Urinary Complications

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Arm I (RARC with IUD)
    Arm Type
    Experimental
    Arm Description
    Patients undergo RARC with IUD.
    Arm Title
    Arm II (RARC with EUD)
    Arm Type
    Experimental
    Arm Description
    Patients undergo RARC with EUD.
    Intervention Type
    Procedure
    Intervention Name(s)
    robot-assisted laparoscopic surgery
    Intervention Description
    Undergo RARC with IUD
    Intervention Type
    Procedure
    Intervention Name(s)
    robot-assisted laparoscopic surgery
    Intervention Description
    Undergo RARC with EUD
    Intervention Type
    Other
    Intervention Name(s)
    intraoperative complication management/prevention
    Intervention Description
    Undergo RARC with IUD
    Intervention Type
    Other
    Intervention Name(s)
    intraoperative complication management/prevention
    Intervention Description
    Undergo RARC with EUD
    Intervention Type
    Other
    Intervention Name(s)
    quality-of-life assessment
    Other Intervention Name(s)
    quality of life assessment
    Intervention Description
    Ancillary studies
    Primary Outcome Measure Information:
    Title
    Complication rate
    Description
    Analyzed using multivariable logistical regression. Descriptions and grading scales found in the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for adverse event reporting.
    Time Frame
    90 days after surgery
    Secondary Outcome Measure Information:
    Title
    Time to passage of flatus
    Description
    Analyzed using regression analysis.
    Time Frame
    Up to 90 days
    Title
    Analgesic requirement (narcotic use)
    Description
    Analyzed using logistical regression.
    Time Frame
    Up to 90 days
    Title
    Hospital length of stay
    Description
    Analyzed using regression analysis.
    Time Frame
    Up to 90 days
    Title
    Total operating time
    Description
    Analyzed using regression analysis.
    Time Frame
    Up to completion of surgery
    Title
    Estimated blood loss
    Description
    Analyzed using regression analysis.
    Time Frame
    Up to 90 days
    Title
    Readmission rate
    Description
    Analyzed using regression analysis.
    Time Frame
    Up to 90 days
    Title
    Quality of life assessed using the Bladder Cancer Index Questionnaire
    Description
    The Cox proportional hazards model will be used. The hazard ratio (HR) and 95% confidence interval (95% CI) associated with the use of RARC with IUD compared with the use of RARC with EUD will be calculated.
    Time Frame
    Up to 5 years
    Title
    Ureteral strictures
    Description
    The Cox proportional hazards model will be used. The HR and 95% CI associated with the use of RARC with IUD compared with the use of RARC with EUD will be calculated.
    Time Frame
    Up to 5 years
    Title
    Stromal stenosis
    Description
    The Cox proportional hazards model will be used. The HR and 95% CI associated with the use of RARC with IUD compared with the use of RARC with EUD will be calculated.
    Time Frame
    Up to 5 years
    Title
    Disease recurrence
    Description
    The Cox proportional hazards model will be used. The HR and 95% CI associated with the use of RARC with IUD compared with the use of RARC with EUD will be calculated.
    Time Frame
    Up to 5 years
    Title
    Secondary procedures
    Description
    The Cox proportional hazards model will be used. The HR and 95% CI associated with the use of RARC with IUD compared with the use of RARC with EUD will be calculated.
    Time Frame
    Up to 5 years
    Title
    Cumulative complication incidence
    Description
    Graphically described using the Kaplan-Meier method. Descriptions and grading scales found in the NCI CTCAE version 4.0 will be utilized for adverse event reporting.
    Time Frame
    Up to 5 years

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Grade G1 - G3 bladder cancer T stage: cTis - T2 N0 M0 American Society of Anesthesiologists (ASA) < 4 Informed consent Eastern Cooperative Oncology Group (ECOG) performance status 2 or better Hemoglobin (Hgb) > 8.0 g/dL White blood cell (WBC) > 2.0 k/uL Platelets > 50,000 Creatinine < 3.0 x upper limit of normal (ULN) Aspartate aminotransferase (AST) < 5.0 x ULN Alanine transaminase (ALT) < 5.0 x ULN Exclusion Criteria: Patient unsuitable for or refusing radical cystectomy T stage ≥ T3 (mass extending outside the bladder) Gross nodal or metastatic disease at presentation (≥ N1, M1) Prior pelvic radiation Prior open or laparoscopic/robotic bladder or prostate surgery Prior colorectal surgery or history of inflammatory bowel disease Body mass index (BMI) ≥ 40 ECOG performance status 3 or worse History of coagulopathy or bleeding disorders Chronic steroid use Patients with end stage renal disease (ESRD) and/or on dialysis
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jihad Kaouk
    Organizational Affiliation
    Case Comprehensive Cancer Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Urinary Diversion During Robotic Assisted Radical Cystectomy in Patients With Bladder Cancer

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