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The Impact of Early Feeding After Radical Cystectomy for Bladder Cancer


Phase 3
18 Years
N/A
Open (Enrolling by invite only)
Both
Bladder Cancer, Complications

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Trial Information

The Impact of Early Feeding After Radical Cystectomy for Bladder Cancer


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

Complication rate

Outcome Description:

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

Outcome Time Frame:

90 day

Safety Issue:

No

Principal Investigator

Christopher Deibert, M.D., M.P.H.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Columbia University

Authority:

United States: Institutional Review Board

Study ID:

AAAI0046

NCT ID:

NCT01489800

Start Date:

November 2011

Completion Date:

June 2014

Related Keywords:

  • Bladder Cancer
  • Complications
  • feeding
  • complications
  • radical cystectomy
  • Urinary Bladder Neoplasms

Name

Location

Columbia Univeristy Medical Center New York, New York  10032
New York Hospital - Cornell New York, New York  10021