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| Name | Class |
|---|---|
| University of Oklahoma | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nutrition Intervention | Experimental | Ensure Plus®, consumed orally twice daily for 2 weeks before and 4 weeks after surgery |
|
| Control | Active Comparator | Over the counter daily multivitamin for 2 weeks before and 4 weeks after surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ensure Plus® | Dietary Supplement |
|
| |
| Multivitamin |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chad R Ritch, MD | Department of Urologic Surgery, Vanderbilt University Medical Center | Principal Investigator |
| Michael S Cookson, MD | Department of Urology, University of Oklahoma Medical Center | Study Director |
| Heidi J Silver, PhD, RD | Vanderbilt Center for Human Nutrition | Study Director |
| Peter E Clark, MD | Department of Urologic Surgery, Vanderbilt University Medical Center | Study Director |
| Sam S Chang, MD | Department of Urologic Surgery, Vanderbilt University Medical Center | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt University Medical Center | Nashville | Tennessee | 37203 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21074802 | Background | Gregg JR, Cookson MS, Phillips S, Salem S, Chang SS, Clark PE, Davis R, Stimson CJ Jr, Aghazadeh M, Smith JA Jr, Barocas DA. Effect of preoperative nutritional deficiency on mortality after radical cystectomy for bladder cancer. J Urol. 2011 Jan;185(1):90-6. doi: 10.1016/j.juro.2010.09.021. Epub 2010 Nov 12. | |
| 20723939 | Background |
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| ID | Term |
|---|---|
| D001749 | Urinary Bladder Neoplasms |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C029401 | Ensure Plus |
| C067316 | Geritol |
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| Dietary Supplement |
|
| 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 |
| Stimson CJ, Chang SS, Barocas DA, Humphrey JE, Patel SG, Clark PE, Smith JA Jr, Cookson MS. Early and late perioperative outcomes following radical cystectomy: 90-day readmissions, morbidity and mortality in a contemporary series. J Urol. 2010 Oct;184(4):1296-300. doi: 10.1016/j.juro.2010.06.007. Epub 2010 Aug 17. |
| 21788035 | Background | Morgan TM, Keegan KA, Barocas DA, Ruhotina N, Phillips SE, Chang SS, Penson DF, Clark PE, Smith JA Jr, Cookson MS. Predicting the probability of 90-day survival of elderly patients with bladder cancer treated with radical cystectomy. J Urol. 2011 Sep;186(3):829-34. doi: 10.1016/j.juro.2011.04.089. Epub 2011 Jul 23. |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |