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BRIEF TITLE: Randomized Clinical Trial of 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.

Detailed Description


This is a randomized clinical trial comparing ICD to ECD following robotic-assisted radical
cystectomy (RARC). All patients will undergo the standard of care for RARC followed by either
extracorporal urinary diversion (ECD) or intracorporal urinary diversion (ICD). RARC will be
performed as per center-specific techniques, which on the whole are comparable. The surgical
approach for ileal conduit formation will be standardized with the requirement for ureteral
stents in all patients. The post-operative care of all patients will involve use of an
enhanced-recovery after surgery (ERAS) protocol. Certain components of this protocol will be
standardized.

Patients will be followed-up as per the usual standard of care for RARC followed by urinary
diversion. History and physical examination are recommended at 30 days, 3, 6, 12, 24 months
postoperatively, and as per the clinician's discretion afterwards. During each follow up
functional assessment for urinary and sexual quality of life will be performed as per the
study calendar.

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

Primary Outcomes:

Primary Outcome 1 - Measure: 90-day 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