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Intracorporeal vs Extracorporeal Urinary Diversion After Robot Assisted Radical Cystectomy

Primary Purpose

Bladder Cancer

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Extracorporeal Urinary Diversion
Intracorporal Urinary Diversion
Da Vinci Robot
Sponsored by
University of Miami
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Bladder Cancer

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Biopsy-proven urothelial cancer being considered for RARC.
  • Clinical stage T1-T4, N0-1, M0 or refractory carcinoma in situ.
  • Subject must be already scheduled to have a RARC at the discretion of the surgeon and with the patient's agreement.

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.

Sites / Locations

  • University of MiamiRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Extracorporeal Urinary Diversion (ECD)

Intracorporal Urinary Diversion (ICD)

Arm Description

Participants will be randomized to receiving ECD after scheduled Robotic Assisted Radical Cystectomy (RARC).

Participants will be randomized to receiving ICD after scheduled Robotic Assisted Radical Cystectomy (RARC).

Outcomes

Primary Outcome Measures

90-day Major Post-Operative Complication Rate
Major complication rate at 90-days from RARC + urinary diversion using the modified Clavien-Dindo grading system. Major complication is defined as Clavien-Dindo Grade ≥ 3.

Secondary Outcome Measures

90-day Any Post-Operative Complication Rate
Any complication rates at 90-days from RARC + urinary diversion, using the modified Clavien-Dindo grading system as low grade (1-2) or high grade (3-5).
Length of Hospital Stay in ECD vs ICD Study Participants
Length of hospital stay for study participants undergoing ECD versus ICD urinary diversion post-RARC, as recorded at hospital discharge.
90-day Readmission Rate
Rate of readmission to hospital at 90 days post-RARC followed by ECD or ICD urinary diversion.
Rate of Return to the Operating room within 90 days
Rate of return to the operating room within 90 days after RARC followed by ICD or ECD Urinary Diversion.
Mortality Rate at 90 days
Rate of mortality (death) at 90 days in study participants
Rate of Bowel-Specific Complications
Rate of bowel-specific complications in study participants (including incidence of mechanical bowel obstruction, anastomotic leaks, and surgical site infections) and post operative pain. Bowel-specific complications will be assessed using the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) version 4.
Functional Independence Recovery as measured by the ADL Questionnaire
Rate of functional independence recovery as measured by patient-reported scores on the Activities of Daily Living (ADL) questionnaire. For the ADL, the total score ranges from 0 to 6, with the higher scores indicating functional improvement and lower scores indicating functional deterioration.
Functional Independence Recovery as measured by the IADL Questionnaire
Rate of functional independence recovery as measured by an aggregate of patient-reported scores on the Instrumental Activities of Daily Living (IADL) questionnaire. For the IADL, the total score ranges from 0 to 8, with higher scores indicating functional functional improvement and lower scores indicating functional deterioration.
Functional Independence Recovery as measured by the Hand Grip Strength Test.
The Hand Grip Strength Test measures the amount of static force that a participant's hand can squeeze around a dynamometer. The test is measured in kilograms.
Functional Independence Recovery as measured by the Timed Up and Go (TUG) Walking Test
The TUG test times participants as they rise from a standard chair, walk 3 meters, turn, walk back and sit again. The test is measured in seconds.
Health-Related Quality of Life (HRQoL) as assessed by SF-8 Health Survey
HRQoL measured by patient scores on the Short Form 8 (SF-8) Health Survey. The SF-8 is a questionnaire consisting of 8-items and two component summary scores: Physical component summary (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 health-related quality of life.
HRQoL as assessed by the FACT-VCI Questionnaire
HRQoL measured by patient scores on the Functional Assessment of Cancer Therapy-Vanderbilt Cystectomy Index (FACT-VCI) questionnaire. The FACT-VCI is a condition-specific instrument for patients undergoing radical cystectomy (RC) and urinary diversion (UD) for bladder cancer. The questionnaire consists of 44 items scored on a range from 0 ("Not at all") to 4 ("Very Much"), resulting in an ordinal Likert scale, with higher scores indicating a better HRQoL. The FACT-VCI measures quality of life across five domains: Physical wellbeing, social/family wellbeing, emotional wellbeing, functional wellbeing and an additional concerns subscale.

Full Information

First Posted
March 6, 2018
Last Updated
May 30, 2023
Sponsor
University of Miami
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1. Study Identification

Unique Protocol Identification Number
NCT03469362
Brief Title
Intracorporeal vs Extracorporeal Urinary Diversion After Robot Assisted Radical Cystectomy
Official Title
Randomized Clinical Trial of Intracorporeal vs Extracorporeal Urinary Diversion After Robot Assisted Radical Cystectomy
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 25, 2018 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
June 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Intracorporeal urinary diversion (ICD) provides superior postoperative outcomes compared to extracorporeal urinary diversion (ECD). The investigators' hypothesis that ICD may provide clinical benefit is based on principles of less bowel and ureteral handling, superior operating room workflow, less exposure to the external environment, and optimal visualization with ICD while utilizing a smaller incision compared to ECD. ICD should have less bowel-related complications, lower pain scores allowing patients to be discharged from the hospital sooner and regain functional independence more quickly.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bladder Cancer

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
88 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Extracorporeal Urinary Diversion (ECD)
Arm Type
Experimental
Arm Description
Participants will be randomized to receiving ECD after scheduled Robotic Assisted Radical Cystectomy (RARC).
Arm Title
Intracorporal Urinary Diversion (ICD)
Arm Type
Experimental
Arm Description
Participants will be randomized to receiving ICD after scheduled Robotic Assisted Radical Cystectomy (RARC).
Intervention Type
Procedure
Intervention Name(s)
Extracorporeal Urinary Diversion
Other Intervention Name(s)
ECD
Intervention Description
Extra-corporeal urinary diversion, provided as part of standard of care, will have the ureters sutured into the ileal conduit by hand.
Intervention Type
Procedure
Intervention Name(s)
Intracorporal Urinary Diversion
Other Intervention Name(s)
ICD
Intervention Description
Intracorporal Urinary Diversion, provided as part of standard of care, will have the ureters sutured into the ileal conduit using the Da Vinci robot.
Intervention Type
Device
Intervention Name(s)
Da Vinci Robot
Intervention Description
Da Vinci Robotic Surgical System
Primary Outcome Measure Information:
Title
90-day Major Post-Operative Complication Rate
Description
Major complication rate at 90-days from RARC + urinary diversion using the modified Clavien-Dindo grading system. Major complication is defined as Clavien-Dindo Grade ≥ 3.
Time Frame
90 days
Secondary Outcome Measure Information:
Title
90-day Any Post-Operative Complication Rate
Description
Any complication rates at 90-days from RARC + urinary diversion, using the modified Clavien-Dindo grading system as low grade (1-2) or high grade (3-5).
Time Frame
90 days
Title
Length of Hospital Stay in ECD vs ICD Study Participants
Description
Length of hospital stay for study participants undergoing ECD versus ICD urinary diversion post-RARC, as recorded at hospital discharge.
Time Frame
About 2 weeks
Title
90-day Readmission Rate
Description
Rate of readmission to hospital at 90 days post-RARC followed by ECD or ICD urinary diversion.
Time Frame
90 days
Title
Rate of Return to the Operating room within 90 days
Description
Rate of return to the operating room within 90 days after RARC followed by ICD or ECD Urinary Diversion.
Time Frame
Up to 90 days
Title
Mortality Rate at 90 days
Description
Rate of mortality (death) at 90 days in study participants
Time Frame
90 days
Title
Rate of Bowel-Specific Complications
Description
Rate of bowel-specific complications in study participants (including incidence of mechanical bowel obstruction, anastomotic leaks, and surgical site infections) and post operative pain. Bowel-specific complications will be assessed using the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) version 4.
Time Frame
Up to 36 months
Title
Functional Independence Recovery as measured by the ADL Questionnaire
Description
Rate of functional independence recovery as measured by patient-reported scores on the Activities of Daily Living (ADL) questionnaire. For the ADL, the total score ranges from 0 to 6, with the higher scores indicating functional improvement and lower scores indicating functional deterioration.
Time Frame
Up to 36 months
Title
Functional Independence Recovery as measured by the IADL Questionnaire
Description
Rate of functional independence recovery as measured by an aggregate of patient-reported scores on the Instrumental Activities of Daily Living (IADL) questionnaire. For the IADL, the total score ranges from 0 to 8, with higher scores indicating functional functional improvement and lower scores indicating functional deterioration.
Time Frame
Up to 36 months
Title
Functional Independence Recovery as measured by the Hand Grip Strength Test.
Description
The Hand Grip Strength Test measures the amount of static force that a participant's hand can squeeze around a dynamometer. The test is measured in kilograms.
Time Frame
Up to 36 months
Title
Functional Independence Recovery as measured by the Timed Up and Go (TUG) Walking Test
Description
The TUG test times participants as they rise from a standard chair, walk 3 meters, turn, walk back and sit again. The test is measured in seconds.
Time Frame
Up to 36 months
Title
Health-Related Quality of Life (HRQoL) as assessed by SF-8 Health Survey
Description
HRQoL measured by patient scores on the Short Form 8 (SF-8) Health Survey. The SF-8 is a questionnaire consisting of 8-items and two component summary scores: Physical component summary (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 health-related quality of life.
Time Frame
Up to 36 months
Title
HRQoL as assessed by the FACT-VCI Questionnaire
Description
HRQoL measured by patient scores on the Functional Assessment of Cancer Therapy-Vanderbilt Cystectomy Index (FACT-VCI) questionnaire. The FACT-VCI is a condition-specific instrument for patients undergoing radical cystectomy (RC) and urinary diversion (UD) for bladder cancer. The questionnaire consists of 44 items scored on a range from 0 ("Not at all") to 4 ("Very Much"), resulting in an ordinal Likert scale, with higher scores indicating a better HRQoL. The FACT-VCI measures quality of life across five domains: Physical wellbeing, social/family wellbeing, emotional wellbeing, functional wellbeing and an additional concerns subscale.
Time Frame
Up to 36 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Biopsy-proven urothelial cancer being considered for RARC. Clinical stage T1-T4, N0-1, M0 or refractory carcinoma in situ. Subject must be already scheduled to have a RARC at the discretion of the surgeon and with the patient's agreement. 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shashana Fiedler
Phone
305-243-6438
Email
sxf780@med.miami.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark L Gonzalgo, MD, PhD
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shashana Fiedler
Phone
305-243-6438
Email
sxf780@med.miami.edu
First Name & Middle Initial & Last Name & Degree
Mark L Gonzalgo, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Intracorporeal vs Extracorporeal Urinary Diversion After Robot Assisted Radical Cystectomy

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