Vanderbilt University Medical Center
Nashville, Tennessee, 37203, United States
NCT Number: NCT02050451
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.
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Notify Me18 year–90 year
All sexes
Interventional
Not applicable
Nashville, Tennessee, 37203, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Other names: Ensure®
Time frame: 30 days
The study is powered to detect a difference in the number of HFDs over a 30 day period between intervention and control groups
Time frame: 30 days
The investigators will compare serum levels of albumin, prealbumin, transferrin and retinol binding protein and C-reactive protein between groups
Time frame: 30 days
The investigators will measure difference in lean body mass and fat mass between intervention and controls using whole body dual energy X-ray absorptiometry (DEXA) scan
Time frame: 30 days
The investigators will assess the patients' ability to tolerate and comply with the nutrition intervention
Time frame: 30 days
The investigators will compare the difference in rate, type and severity of post-operative complications between groups
Time frame: 30 days
The investigators will compare the length of stay following surgery between the two groups
Time frame: 30 days
The investigators will compare the rate of readmissions over the 30 day postoperative period between intervention and control
Time frame: 30 days
The investigators will compare overall survival between groups over the 30 day postoperative period
Time frame: 30 days
The investigators will compare caloric and nutrient intake between groups using comprehensive dietary assessment tools
Vanderbilt University
Other
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
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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