Intracorporeal Vs Extracorporeal Urinary Diversion After Robot Assisted Radical Cystectomy

Randomized Clinical Trial of Intracorporeal Vs Extracorporeal Urinary Diversion After Robot Assisted Radical Cystectomy

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.

Study Overview

• Status: Completed
• Conditions: Bladder Cancer
• Intervention / Treatment: Procedure: Extracorporeal Urinary Diversion; Procedure: Intracorporal Urinary Diversion

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • University of Miami

Participation Criteria

Eligibility Criteria

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

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: ICD

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	90 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	90 days
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.	About 2 weeks
90-day Readmission Rate	Rate of readmission to hospital at 90 days post-RARC followed by ECD or ICD urinary diversion.	90 days
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.	Up to 90 days
Mortality Rate at 90 days	Rate of mortality (death) at 90 days in study participants	90 days
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.	Up to 36 months
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.	Up to 36 months
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.	Up to 36 months
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.	Up to 36 months
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.	Up to 36 months
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.	Up to 36 months
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.	Up to 36 months

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): April 25, 2018
• Primary Completion (Actual): August 20, 2024
• Study Completion (Actual): September 11, 2024

Study Registration Dates

• First Submitted: March 6, 2018
• First Submitted That Met QC Criteria: March 12, 2018
• First Posted (Actual): March 19, 2018

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 20, 2025
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urologic Neoplasms; Urinary Bladder Diseases; Urinary Bladder Neoplasms
• Other Study ID Numbers: 20170004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No