The Impact of Early Feeding After Radical Cystectomy for Bladder Cancer
Subjects preparing to undergo radical cystectomy and urinary diversion for bladder cancer
that provide informed consent will be randomized into 1 of 2 study arms. The experimental
arm will be offered clear liquid diet 24 hours after extubation and advanced to regular diet
24 hours later if clear liquids are well tolerated. The standard/control arm will receive a
clear liquid diet at the time of return of bowel function, determined by significant flatus
or bowel movements.
Information related to time to return of bowel function, frequency of nausea/vomiting,
hospital complications and length of stay will be recorded. Patients will be followed with
phone calls and chart reviews at 30, 60 and 90 days following surgery. Additional hospital
admissions and/or complications will be determined with those phone calls.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
powered to detect 50% reduction in complication rate, from 40% down to 20%
Christopher Deibert, M.D., M.P.H.
United States: Institutional Review Board
|Columbia Univeristy Medical Center||New York, New York 10032|
|New York Hospital - Cornell||New York, New York 10021|