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Clinical trialNCT02050451CompletedInterventional

Perioperative Oral Nutrition Intervention for Patients Undergoing Radical Cystectomy

SponsorVanderbilt UniversityEnrollment60Bladder Cancer
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

  • Chad R Ritch, MD

    Department of Urologic Surgery, Vanderbilt University Medical Center

    Principal Investigator
  • Heidi J Silver, PhD, RD

    Vanderbilt Center for Human Nutrition

    Study Director
  • Michael S Cookson, MD

    Department of Urology, University of Oklahoma Medical Center

    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

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

1 registered facility, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • Vanderbilt University Medical Center

    Nashville, Tennessee, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

No drug or biological interventions are in our data for this study. It may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
31 Mar 2014
Primary completion
31 Dec 2016
Completion
31 Mar 2017
Last update posted
29 Mar 2017
Registered enrollment
60
Registry id
NCT02050451

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.