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Brief Title: Intra-corporal vs Extra-corporal Urinary Diversion After Robot Assisted Radical Cystectomy

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

INTRODUCTION

  • Org Study ID: 20170004
  • Secondary ID: N/A
  • NTC ID: NCT03469362
  • Sponsor: University of Miami

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.

  • Overall Status
    Recruiting
  • Start Date
    April 25, 2018
  • Phase
    Not Applicable
  • Study Type
    Interventional

PRIMARY OUTCOMES

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

Primary Outcome 1 - Timeframe: 90 days

CONDITION

  • Bladder Cancer

ELIGIBILITY

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.

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

Overall Contact

Name: Mark L Gonzalgo, MD, PhD

Phone: 305-243-2177

Email: rxb773@med.miami.edu

LOCATION

Facility Status Contact
Facility: Rody Barakat
Miami, Florida 33136
United States
Status: Recruiting Contact: Contact
Rody L Barakat
305-243-2177
rxb773@med.miami.edu