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BRIEF TITLE: Intra-corporal vs Extra-corporal Urinary Diversion After Robot Assisted Radical Cystectomy

Randomized Clinical Trial of Intra-corporal vs Extra-corporal Urinary Diversion After Robot Assisted Radical Cystectomy


  • Org Study ID: 20170004
  • Secondary ID:
  • NCT ID: NCT03469362
  • NCT Alias:
  • Sponsor: University of Miami - Other
  • Source: University of Miami

Brief Summary

Intracorporal urinary diversion (ICD) provides superior postoperative outcomes compared to extracorporal 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.

Overal Status Start Date Phase Study Type
Recruiting April 25, 2018 N/A Interventional

Primary Outcomes:

Primary Outcome 1 - Measure: 90-day Major Post-Operative Complication Rate

Primary Outcome 1 - Time Frame: 90 days

Condition:

  • Bladder Cancer

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.
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Gender: All

Minimum Age: 18 Years

Maximum Age: 99 Years

Healthy Volunteers: No

Official Information

Name: Mark L Gonzalgo, MD, PhD

Role: Principal Investigator

Affiliation: University of Miami

Location

Facility Status Contact
University of Miami
Miami, Florida 33136
United States
Recruiting Mark L Gonzalgo, MD, PhD
305-243-6591
m.gonzalgo@med.miami.edu