Recurrent Bladder Cancer Clinical Trial
Official title:
Prospective Randomized Comparison of Intracorporeal Versus Extracorporeal Urinary Diversion During Robotic Radical Cystectomy
This randomized clinical trial studies intracorporeal or extracorporeal urinary diversion during robotic assisted radical cystectomy in reducing complications in patients with bladder cancer. Radical cystectomy is surgery to remove the entire bladder as well as nearby tissues and organs. After the bladder is removed, urinary diversion (a surgical procedure to make a new way for urine to leave the body) is performed. It is not yet known whether intracorporeal (within the body) or extracorporeal (outside of the body) urinary diversion is a better method in patients with bladder cancer undergoing robotic assisted radical cystectomy.
PRIMARY OBJECTIVES:
I. To compare perioperative outcomes and complications after robotic assisted radical
cystectomy (RARC) with intracorporeal urinary diversion (IUD) and RARC with extracorporeal
urinary diversion (EUD) in a prospective randomized fashion.
SECONDARY OBJECTIVES:
I. Time to passage of flatus. II. Analgesic requirement (narcotic use). III. Hospital length
of stay. IV. Total operating time. V. Estimated blood loss. VI. Readmission rate. VII.
Bladder Cancer Index Questionnaire. VIII. Ureteral strictures. IX. Stomal stenosis. X.
Disease recurrence. XI. Secondary procedures.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients undergo RARC with IUD.
ARM II: Patients undergo RARC with EUD.
After completion of study treatment, patients are followed up within 90 days and then for
2-5 years.
;
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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