Principal Investigator
Enrollment Status
Clinical Trial ID
Clinical Trial 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.
Phase
N/A
Funding Agency/Sponsor
Institutional
Disease
Prostate, Bladder, and Kidney Cancers
Enrollment 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.