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The Impact of Early Feeding After Radical Cystectomy for Bladder Cancer

The Impact of Early Feeding After Radical Cystectomy for Bladder Cancer

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01489800
Enrollment
102
Registered
2011-12-12
Start date
2011-11-30
Completion date
2015-01-31
Last updated
2021-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bladder Cancer, Complications

Keywords

feeding, complications, radical cystectomy

Brief 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.

Interventions

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

Sponsors

Columbia University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Age \>=18 * Bladder cancer * Elect radical cystectomy and urinary diversion as treatment * Able to provide informed consent

Exclusion criteria

* Radical cystectomy for reason other than bladder cancer

Design outcomes

Primary

MeasureTime frameDescription
Complication rate90 daypowered to detect 50% reduction in complication rate, from 40% down to 20%

Secondary

MeasureTime frameDescription
Primary Hospital Length of Stay30 daystime from admission for surgery until discharge after surgery

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026