Perioperative Oral Nutrition Intervention for Patients Undergoing Radical Cystectomy

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.

Conditions

• Bladder Cancer

Interventions

DIETARY_SUPPLEMENT

Ensure Plus®

DIETARY_SUPPLEMENT

Multivitamin

Sponsors & Collaborators

• University of Oklahoma

  collaborator OTHER

• Vanderbilt University

  lead OTHER

Principal Investigators

• Chad R Ritch, MD · Department of Urologic Surgery, Vanderbilt University Medical Center

• Michael S Cookson, MD · Department of Urology, University of Oklahoma Medical Center

• Heidi J Silver, PhD, RD · Vanderbilt Center for Human Nutrition

• Peter E Clark, MD · Department of Urologic Surgery, Vanderbilt University Medical Center

• Sam S Chang, MD · Department of Urologic Surgery, Vanderbilt University Medical Center

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

90 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-03-31

Primary Completion

2016-12-31

Completion

2017-03-31

Countries

• United States

Study Locations