Perioperative Oral Nutrition Intervention for Patients Undergoing Radical Cystectomy

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Bladder Cancer

Intervention / Treatment
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* Dietary Supplement: Ensure Plus®
* Dietary Supplement: Multivitamin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: all patients eligible for elective radical cystectomy for bladder cancer at the sponsoring institution Exclusion Criteria: inability to tolerate oral supplementation

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nutrition Intervention<br>Ensure Plus®, consumed orally twice daily for 2 weeks before and 4 weeks after surgery | Dietary Supplement: Ensure Plus®<br> <br> * Other names: Ensure®;|
| Active Comparator: Control<br>Over the counter daily multivitamin for 2 weeks before and 4 weeks after surgery | Dietary Supplement: Multivitamin<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital-free days (HFDs) | The study is powered to detect a difference in the number of HFDs over a 30 day period between intervention and control groups | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum markers | The investigators will compare serum levels of albumin, prealbumin, transferrin and retinol binding protein and C-reactive protein between groups | 30 days | 
| Body composition | 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 | 30 days | 
| Tolerability / compliance | The investigators will assess the patients' ability to tolerate and comply with the nutrition intervention | 30 days | 
| Complications | The investigators will compare the difference in rate, type and severity of post-operative complications between groups | 30 days | 
| Length of stay | The investigators will compare the length of stay following surgery between the two groups | 30 days | 
| Readmission rate | The investigators will compare the rate of readmissions over the 30 day postoperative period between intervention and control | 30 days | 
| Mortality | The investigators will compare overall survival between groups over the 30 day postoperative period | 30 days | 
| Calories | The investigators will compare caloric and nutrient intake between groups using comprehensive dietary assessment tools | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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oral supplementation, enteral nutrition, radical cystectomy, urinary diversion, nutrition