Help guide our efforts to modernize
Send us your comments by March 14, 2020. Menu

The Impact of Early Feeding After Radical Cystectomy for Bladder Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01489800
Recruitment Status : Unknown
Verified July 2015 by Columbia University.
Recruitment status was:  Enrolling by invitation
First Posted : December 12, 2011
Last Update Posted : July 3, 2015
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Bladder Cancer Complications Behavioral: Clear liquid diet Phase 3

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 164 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The Impact of Early Feeding After Radical Cystectomy for Bladder Cancer
Study Start Date : November 2011
Estimated Primary Completion Date : July 2015
Estimated Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bladder Cancer

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. Complication rate [ Time Frame: 90 day ]
    powered to detect 50% reduction in complication rate, from 40% down to 20%

Secondary Outcome Measures :
  1. Primary Hospital Length of Stay [ Time Frame: 30 days ]
    time from admission for surgery until discharge after surgery

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01489800

Layout table for location information
United States, New York
New York Hospital - Cornell
New York, New York, United States, 10021
Columbia Univeristy Medical Center
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
Layout table for investigator information
Principal Investigator: Christopher Deibert, M.D., M.P.H. Columbia University

Layout table for additonal information
Responsible Party: Columbia University Identifier: NCT01489800    
Other Study ID Numbers: AAAI0046
First Posted: December 12, 2011    Key Record Dates
Last Update Posted: July 3, 2015
Last Verified: July 2015
Keywords provided by Columbia University:
radical cystectomy
Additional relevant MeSH terms:
Layout table for MeSH terms
Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Urinary Bladder Diseases
Urologic Diseases