The Impact of Early Feeding After Radical Cystectomy for Bladder Cancer
Complications after radical cystectomy for bladder cancer range from 30-40%, many of which are related to bowel function. Patients usually wait to eat until return of bowel function, although there is evidence that after primary intestinal or colonic surgery, patients may take food ad lib immediately, and that this is is associated with lower complication rate and shorter length of stay. The investigators hypothesize that early access to oral enteral nutrition (food at will) after cystectomy and urinary diversion will reduce the complication rate both in-hospital and within 90 days after hospital discharge.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||The Impact of Early Feeding After Radical Cystectomy for Bladder Cancer|
- Complication rate [ Time Frame: 90 day ] [ Designated as safety issue: No ]powered to detect 50% reduction in complication rate, from 40% down to 20%
- Primary Hospital Length of Stay [ Time Frame: 30 days ] [ Designated as safety issue: No ]time from admission for surgery until discharge after surgery
|Study Start Date:||November 2011|
|Estimated Study Completion Date:||June 2014|
|Estimated Primary Completion Date:||June 2014 (Final data collection date for primary outcome measure)|
Experimental: Early Feeding
Introduction of clear liquid diet 24 hours after extubation with advancement to regular diet 24 hours thereafter if there is no significant nausea or vomiting.
Behavioral: Clear liquid diet
clear liquid diet, the same for each arm, will be given 24 hours after extubation as the intervention in the experimental arm.
Other Name: liquid diet
No Intervention: Control Feeding
Standard of care with introduction of clear liquid diet at time of return of bowel function as determined by flatus. Advancement to full diet 24 later if clear diet well tolerated.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01489800
|United States, New York|
|Columbia Univeristy Medical Center|
|New York, New York, United States, 10032|
|New York Hospital - Cornell|
|New York, New York, United States, 10021|
|Principal Investigator:||Christopher Deibert, M.D., M.P.H.||Columbia University|