Perioperative Oral Nutrition Intervention for Patients Undergoing Radical Cystectomy
NCT ID: NCT02050451
Last Updated: 2017-03-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2014-03-31
2017-03-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Nutrition Intervention
Ensure Plus®, consumed orally twice daily for 2 weeks before and 4 weeks after surgery
Ensure Plus®
Control
Over the counter daily multivitamin for 2 weeks before and 4 weeks after surgery
Multivitamin
Interventions
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Ensure Plus®
Multivitamin
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
90 Years
ALL
No
Sponsors
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University of Oklahoma
OTHER
Vanderbilt University
OTHER
Responsible Party
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Chad Ritch
Clinical Instructor
Principal Investigators
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Chad R Ritch, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Urologic Surgery, Vanderbilt University Medical Center
Michael S Cookson, MD
Role: STUDY_DIRECTOR
Department of Urology, University of Oklahoma Medical Center
Heidi J Silver, PhD, RD
Role: STUDY_DIRECTOR
Vanderbilt Center for Human Nutrition
Peter E Clark, MD
Role: STUDY_DIRECTOR
Department of Urologic Surgery, Vanderbilt University Medical Center
Sam S Chang, MD
Role: STUDY_DIRECTOR
Department of Urologic Surgery, Vanderbilt University Medical Center
Locations
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Vanderbilt University Medical Center
Nashville, Tennessee, United States
Countries
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References
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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.
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.
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.
Other Identifiers
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VU-IRB-131560
Identifier Type: -
Identifier Source: org_study_id
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