Spots Global Cancer Trial Database for Perioperative Oral Nutrition Intervention for Patients Undergoing Radical Cystectomy
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Trial Identification
Brief Title: Perioperative Oral Nutrition Intervention for Patients Undergoing Radical Cystectomy
Official Title: 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
Study ID: NCT02050451
Conditions
Study Description
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:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Vanderbilt University Medical Center, Nashville, Tennessee, United States
Contact Details
Name: Chad R Ritch, MD
Affiliation: Department of Urologic Surgery, Vanderbilt University Medical Center
Role: PRINCIPAL_INVESTIGATOR
Name: Michael S Cookson, MD
Affiliation: Department of Urology, University of Oklahoma Medical Center
Role: STUDY_DIRECTOR
Name: Heidi J Silver, PhD, RD
Affiliation: Vanderbilt Center for Human Nutrition
Role: STUDY_DIRECTOR
Name: Peter E Clark, MD
Affiliation: Department of Urologic Surgery, Vanderbilt University Medical Center
Role: STUDY_DIRECTOR
Name: Sam S Chang, MD
Affiliation: Department of Urologic Surgery, Vanderbilt University Medical Center
Role: STUDY_DIRECTOR
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