Intracorporeal vs Extracorporeal Urinary Diversion After Robot Assisted Radical Cystectomy

  • STATUS
    Recruiting
  • End date
    Jun 23, 2026
  • participants needed
    88
  • sponsor
    University of Miami
Updated on 23 March 2022
radical cystectomy
cancer
carcinoma
carcinoma in situ
urinary diversion
ileal conduit

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.

Details
Condition Bladder Cancer
Treatment Activities of Daily Living, Activities of Daily Living, Instrumental Activities of Daily Living, Hand Grip Strength Test, Timed Up and Go Walking Test, SF-8, FACT-VCI, Extracorporeal Urinary Diversion, Intracorporal Urinary Diversion, Da Vinci Robot
Clinical Study IdentifierNCT03469362
SponsorUniversity of Miami
Last Modified on23 March 2022

Eligibility

Yes No Not Sure

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
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