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Completed

NCT Number: NCT03469362

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.

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Key information

Conditions

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

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Miami

Miami, Florida, 33136, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Extracorporeal Urinary Diversion

Procedure

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

Intracorporal Urinary Diversion

Procedure

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2024
Study completion
2024
First posted
Mar 19, 2018
Registry last updated
Mar 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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