Clinical Trials Directory

Trials / Completed

CompletedNCT01489800

The Impact of Early Feeding After Radical Cystectomy for Bladder Cancer

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
102 (actual)
Sponsor
Columbia University · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

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.

Detailed description

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALClear liquid dietclear liquid diet, the same for each arm, will be given 24 hours after extubation as the intervention in the experimental arm.

Timeline

Start date
2011-11-01
Primary completion
2015-01-01
Completion
2015-01-01
First posted
2011-12-12
Last updated
2021-08-17

Locations

2 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT01489800. Inclusion in this directory is not an endorsement.