The Impact of Early Feeding After Radical Cystectomy for Bladder Cancer
|ClinicalTrials.gov 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
|Condition or disease||Intervention/treatment||Phase|
|Bladder Cancer Complications||Behavioral: Clear liquid diet||Phase 3|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||164 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
- Complication rate [ Time Frame: 90 day ]powered to detect 50% reduction in complication rate, from 40% down to 20%
- Primary Hospital Length of Stay [ Time Frame: 30 days ]time from admission for surgery until discharge after surgery
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01489800
|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|
|Principal Investigator:||Christopher Deibert, M.D., M.P.H.||Columbia University|