The Impact of Early Feeding After Radical Cystectomy for Bladder Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Impact of Early Feeding After Radical Cystectomy for Bladder Cancer

Conditions
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Bladder Cancer, Complications

Intervention / Treatment
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* Behavioral: Clear liquid diet


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Early Feeding<br>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<br>* clear liquid diet, the same for each arm, will be given 24 hours after extubation as the intervention in the experimental arm.<br>* Other names: liquid diet;|
| No Intervention: Control Feeding<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complication rate | powered to detect 50% reduction in complication rate, from 40% down to 20% | 90 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Hospital Length of Stay | time from admission for surgery until discharge after surgery | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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feeding, complications, radical cystectomy