The Impact of Early Feeding After Radical Cystectomy for Bladder Cancer

Not Applicable

Completed

• Conditions: Complications; Bladder Cancer
• Interventions: Behavioral: Clear liquid diet

• Registration Number: NCT01489800
• Lead Sponsor: Columbia University

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.

Study Timeline

• Study Start: 2011-11
• Study First Submitted: 2011-12-08
• Study First Submitted QC: 2011-12-09
• Study First Posted: 2011-12-12
• Primary Completion: 2015-01
• Study Completion: 2015-01
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-13
• Last Update Posted: 2021-08-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 102

Inclusion Criteria

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

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Exclusion Criteria

• Radical cystectomy for reason other than bladder cancer

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Early Feeding	Clear liquid diet	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.

Primary Outcome Measures

Name	Time	Method
Complication rate	90 day	powered to detect 50% reduction in complication rate, from 40% down to 20%

Secondary Outcome Measures

Name	Time	Method
Primary Hospital Length of Stay	30 days	time from admission for surgery until discharge after surgery

Trial Locations

Locations (2)

New York Hospital - Cornell; 🇺🇸 New York, New York, United States

Columbia Univeristy Medical Center; 🇺🇸 New York, New York, United States