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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Vanderbilt University
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Hospital-free days (HFDs)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •all patients eligible for elective radical cystectomy for bladder cancer at the sponsoring institution
Exclusion Criteria
- •inability to tolerate oral supplementation
Arms & Interventions
Nutrition Intervention
Ensure Plus®, consumed orally twice daily for 2 weeks before and 4 weeks after surgery
Intervention: Ensure Plus® (Dietary Supplement)
Control
Over the counter daily multivitamin for 2 weeks before and 4 weeks after surgery
Intervention: Multivitamin (Dietary Supplement)
Outcomes
Primary Outcomes
Hospital-free days (HFDs)
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
Secondary Outcomes
- Complications(30 days)
- Length of stay(30 days)
- Body composition(30 days)
- Calories(30 days)
- Serum markers(30 days)
- Tolerability / compliance(30 days)
- Readmission rate(30 days)
- Mortality(30 days)
Investigators
Chad Ritch
Clinical Instructor
Vanderbilt University