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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: Completed NA study, sponsored by Vanderbilt University.
NCT02050451 is a NA study that has completed, run by Vanderbilt University. The registered enrollment target is 60 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The study is powered to detect a difference in the number of HFDs over a 30 day period between intervention and control groups
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 |
What the finished NCT02050451 record still lists
NCT02050451 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 2 interventions - of which Multivitamin is the first listed.
NCT02050451 does not publish any study locations in the registry export this page uses.
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
How this trial's enrollment target compares
Where NCT02050451's enrollment target sits among peer trials
60 1164th of 2000 higher than 745 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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