Bladder Cancer Clinical Trial

Intracorporeal vs Extracorporeal Urinary Diversion After Robot Assisted Radical Cystectomy

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.

View Eligibility Criteria

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.

Study is for people with:

Bladder Cancer

Estimated Enrollment:

88

Study ID:

NCT03469362

Recruitment Status:

Recruiting

Sponsor:

University of Miami

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There is 1 Location for this study

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University of Miami
Miami Florida, 33136, United States More Info
Shashana Fiedler
Contact
305-243-6438
[email protected]
Mark L Gonzalgo, MD, PhD
Principal Investigator

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Study is for people with:

Bladder Cancer

Estimated Enrollment:

88

Study ID:

NCT03469362

Recruitment Status:

Recruiting

Sponsor:


University of Miami

How clear is this clinincal trial information?

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