Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT02050451 · ClinicalTrials.gov registry record · NA
Perioperative Oral Nutrition Intervention for Patients Undergoing Radical Cystectomy
A NA study, sponsored by Vanderbilt University.
- Completed
- Registry status
- NA
- Development phase
- 60
- Enrollment target
NCT02050451 is a NA study that has completed, run by Vanderbilt University. The registered enrollment target is 60 participants.
The verdict
NCT02050451, a NA study, has completed, sponsored by Vanderbilt University.
- COMPLETED
- Registry status
- NA
- Development phase
- 60 participants
- Enrollment target
Study 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.
Interventions
- DIETARY_SUPPLEMENT Multivitamin
- DIETARY_SUPPLEMENT Ensure Plus®
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2014-03 |
| Est. Completion | 2017-03 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02050451
The ClinicalTrials.gov registry entry for NCT02050451 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Vanderbilt University, which has 430 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Multivitamin is the first listed.
NCT02050451 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02050451 about?
NCT02050451 is a clinical study titled "Perioperative Oral Nutrition Intervention for Patients Undergoing Radical Cystectomy". 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 th...
What is the current status of trial NCT02050451?
This trial is currently completed. It is a NA study. The enrollment target is 60 participants. The study started on 2014-03. Estimated completion is 2017-03.
What interventions are being tested in trial NCT02050451?
The interventions under investigation include: Multivitamin (DIETARY_SUPPLEMENT), Ensure Plus® (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT02050451?
This trial is sponsored by Vanderbilt University, which has 430 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.