Perioperative Oral Nutrition Intervention for Patients Undergoing Radical Cystectomy
Conditions
Bladder Cancer
Conditions: Keywords
radical cystectomy, urinary diversion, nutrition, oral supplementation, enteral nutrition
Study Type
Interventional
Study Phase
N/A
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Intervention
Name: Ensure Plus® Type: Dietary Supplement
Name: Multivitamin Type: Dietary Supplement
Overall Status
Recruiting
Summary
The current study is designed to assess the impact of an enriched oral nutritional shake (Ensure Plus®) to improve the nutritional status and patient outcome after surgery to remove a cancerous bladder (radical cystectomy). Radical cystectomy with urinary diversion using a segment of intestine is the standard of care for invasive bladder cancer. This operation has a high complication rate and several studies have shown that this may be directly related to poor nutrition.

The investigators believe that patients who consume an enriched nutritional shake before and after surgery will improve their nutrition status and experience fewer complications, shorter length of stay and less readmissions compared to those who do not.

Patients who are scheduled to undergo elective radical cystectomy will be eligible for enrollment. Once enrolled, they will be randomly assigned to one of two groups. One group will be offered Ensure Plus® twice daily for 2 weeks before and 4 weeks after their surgery and the other will be offered a daily over-the-counter multivitamin for the same period of time. The investigators will follow both groups for up to 30 days after their surgery and compare clinical outcomes such as: complication rates, length of stay, readmission rates and mortality as well as measure serum markers of nutrition status and assess changes in body composition.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 90 Years
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

- all patients eligible for elective radical cystectomy for bladder cancer at the sponsoring institution

Exclusion Criteria:

- inability to tolerate oral supplementation
Location
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Status: Recruiting
Contact: Chad Ritch, MD - chad.ritch@vanderbilt.edu
Start Date
March 2014
Completion Date
December 2015
Sponsors
Vanderbilt University
Source
Vanderbilt University
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page