Perioperative Oral Nutrition Intervention for Patients Undergoing Radical Cystectomy



Status:Completed
Conditions:Cancer, Cancer, Hospital, Bladder Cancer
Therapuetic Areas:Oncology, Other
Healthy:No
Age Range:18 - 90
Updated:4/2/2016
Start Date:March 2014
End Date:December 2015
Contact:Chad R Ritch, MD
Email:chad.ritch@vanderbilt.edu
Phone:615-322-2101

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A Pilot Study of Perioperative Oral Nutrition Supplementation to Improve Nutritional Status, Post-operative Complications, Length of Stay and Readmission Rates in Patients Undergoing Radical Cystectomy

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.


Inclusion Criteria:

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

Exclusion Criteria:

- inability to tolerate oral supplementation
We found this trial at
1
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1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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