Perioperative Oral Nutrition Intervention for Patients Undergoing Radical Cystectomy
- Conditions
- Bladder Cancer
- Interventions
- Dietary Supplement: MultivitaminDietary Supplement: Ensure Plus®
- Registration Number
- NCT02050451
- Lead Sponsor
- Vanderbilt University
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
- all patients eligible for elective radical cystectomy for bladder cancer at the sponsoring institution
- inability to tolerate oral supplementation
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control Multivitamin Over the counter daily multivitamin for 2 weeks before and 4 weeks after surgery Nutrition Intervention Ensure Plus® Ensure Plus®, consumed orally twice daily for 2 weeks before and 4 weeks after surgery
- Primary Outcome Measures
Name Time Method Hospital-free days (HFDs) 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
- Secondary Outcome Measures
Name Time Method Complications 30 days The investigators will compare the difference in rate, type and severity of post-operative complications between groups
Length of stay 30 days The investigators will compare the length of stay following surgery between the two groups
Body composition 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
Calories 30 days The investigators will compare caloric and nutrient intake between groups using comprehensive dietary assessment tools
Serum markers 30 days The investigators will compare serum levels of albumin, prealbumin, transferrin and retinol binding protein and C-reactive protein between groups
Tolerability / compliance 30 days The investigators will assess the patients' ability to tolerate and comply with the nutrition intervention
Readmission rate 30 days The investigators will compare the rate of readmissions over the 30 day postoperative period between intervention and control
Mortality 30 days The investigators will compare overall survival between groups over the 30 day postoperative period
Trial Locations
- Locations (1)
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States