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The Impact of Early Feeding After Radical Cystectomy for Bladder Cancer

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
New York Presbyterian Hospital
Information provided by (Responsible Party):
Chris Deibert, Columbia University
ClinicalTrials.gov Identifier:
NCT01489800
First received: December 8, 2011
Last updated: December 9, 2011
Last verified: December 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Bladder Cancer
Complications
 Behavioral: Clear liquid diet
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: The Impact of Early Feeding After Radical Cystectomy for Bladder Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Columbia University:

Primary Outcome Measures:
  • Complication rate [ Time Frame: 90 day ] [ Designated as safety issue: No ]
    powered to detect 50% reduction in complication rate, from 40% down to 20%


Secondary Outcome Measures:
  • Primary Hospital Length of Stay [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    time from admission for surgery until discharge after surgery


Estimated Enrollment: 164
Study Start Date: November 2011
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Early Feeding
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
clear liquid diet, the same for each arm, will be given 24 hours after extubation as the intervention in the experimental arm.
Other Name: liquid diet
No Intervention: Control Feeding
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01489800

Locations
United States, New York
Columbia Univeristy Medical Center
New York, New York, United States, 10032
New York Hospital - Cornell
New York, New York, United States, 10021
Sponsors and Collaborators
Columbia University
New York Presbyterian Hospital
Investigators
Principal Investigator: Christopher Deibert, M.D., M.P.H. Columbia University
  More Information

Publications:

Responsible Party: Chris Deibert, Urology Resident, Columbia University
ClinicalTrials.gov Identifier: NCT01489800     History of Changes
Other Study ID Numbers: AAAI0046
Study First Received: December 8, 2011
Last Updated: December 9, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Columbia University:
feeding
complications
radical cystectomy

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
 Neoplasms
Urinary Bladder Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on May 19, 2013