Intracorporeal vs Extracorporeal Urinary Diversion After Robot Assisted Radical Cystectomy

• ClinicalTrials.gov Identifier: NCT03469362
• Recruitment Status: Recruiting
• First Posted: March 19, 2018
• Last Update Posted: March 1, 2021
• Sponsor: University of Miami
• Information provided by (Responsible Party): Mark L. Gonzalgo, MD, University of Miami

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.

Condition or disease	Intervention/treatment	Phase
Bladder Cancer	Procedure: Extracorporeal Urinary Diversion; Procedure: Intracorporal Urinary Diversion; Device: Da Vinci Robot	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 88 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Randomized Clinical Trial of Intracorporeal vs Extracorporeal Urinary Diversion After Robot Assisted Radical Cystectomy
• Actual Study Start Date: April 25, 2018
• Estimated Primary Completion Date: June 2023
• Estimated Study Completion Date: June 2026

Arms and Interventions

Arm	Intervention/treatment
Experimental: Extracorporeal Urinary Diversion (ECD); Participants will be randomized to receiving ECD after scheduled Robotic Assisted Radical Cystectomy (RARC).	Procedure: Extracorporeal Urinary Diversion; Extra-corporeal urinary diversion, provided as part of standard of care, will have the ureters sutured into the ileal conduit by hand.; Other Name: ECD
Experimental: Intracorporal Urinary Diversion (ICD); Participants will be randomized to receiving ICD after scheduled Robotic Assisted Radical Cystectomy (RARC).	Procedure: Intracorporal Urinary Diversion; Intracorporal Urinary Diversion, provided as part of standard of care, will have the ureters sutured into the ileal conduit using the Da Vinci robot.; Other Name: ICD; Device: Da Vinci Robot; Da Vinci Robotic Surgical System

Outcome Measures

Primary Outcome Measures :

1. 90-day Major Post-Operative Complication Rate [ Time Frame: 90 days ]
   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 :

1. 90-day Any Post-Operative Complication Rate [ Time Frame: 90 days ]
   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).
2. Length of Hospital Stay in ECD vs ICD Study Participants [ Time Frame: About 2 weeks ]
   Length of hospital stay for study participants undergoing ECD versus ICD urinary diversion post-RARC, as recorded at hospital discharge.
3. 90-day Readmission Rate [ Time Frame: 90 days ]
   Rate of readmission to hospital at 90 days post-RARC followed by ECD or ICD urinary diversion.
4. Rate of Return to the Operating room within 90 days [ Time Frame: Up to 90 days ]
   Rate of return to the operating room within 90 days after RARC followed by ICD or ECD Urinary Diversion.
5. Mortality Rate at 90 days [ Time Frame: 90 days ]
   Rate of mortality (death) at 90 days in study participants
6. Rate of Bowel-Specific Complications [ Time Frame: Up to 36 months ]
   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.
7. Functional Independence Recovery as measured by the ADL Questionnaire [ Time Frame: Up to 36 months ]
   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.
8. Functional Independence Recovery as measured by the IADL Questionnaire [ Time Frame: Up to 36 months ]
   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.
9. Functional Independence Recovery as measured by the Hand Grip Strength Test. [ Time Frame: Up to 36 months ]
   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.
10. Functional Independence Recovery as measured by the Timed Up and Go (TUG) Walking Test [ Time Frame: Up to 36 months ]
    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.
11. Health-Related Quality of Life (HRQoL) as assessed by SF-8 Health Survey [ Time Frame: Up to 36 months ]
    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.
12. HRQoL as assessed by the FACT-VCI Questionnaire [ Time Frame: Up to 36 months ]
    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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 99 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Contacts

Contact: Rody Barakat; 305-243-2177; rxb773@med.miami.edu

Locations

United States, Florida

Rody Barakat; Recruiting

Miami, Florida, United States, 33136

Contact: Rody L Barakat 305-243-2177 rxb773@med.miami.edu

Principal Investigator: Mark L Gonzalgo, MD, PhD

Sponsors and Collaborators

University of Miami

Investigators

• Principal Investigator: Mark L Gonzalgo, MD, PhD; University of Miami

More Information

• Responsible Party: Mark L. Gonzalgo, MD, Professor of Clinical, University of Miami
• ClinicalTrials.gov Identifier: NCT03469362
• Other Study ID Numbers: 20170004
• First Posted: March 19, 2018
• Last Update Posted: March 1, 2021
• Last Verified: February 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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

Additional relevant MeSH terms:

Urinary Bladder Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Urinary Bladder Diseases; Urologic Diseases