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Completed

NCT Number: NCT01489800

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.

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Key information

Conditions

Bladder Cancer Complications Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Neoplasms Neoplasms by Site Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Columbia Univeristy Medical Center, New York, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Clear liquid diet

Behavioral

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

Other names: liquid diet

Primary outcomes

  1. Complication rate

    Time frame: 90 day

    powered to detect 50% reduction in complication rate, from 40% down to 20%

Secondary outcomes

  1. Primary Hospital Length of Stay

    Time frame: 30 days

    time from admission for surgery until discharge after surgery

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Sponsors and collaborators

Lead sponsor

Columbia University

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Registry information

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Dec 12, 2011
Registry last updated
Aug 17, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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