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NCT01947166 · ClinicalTrials.gov registry record · NA
Pancreatic Resection, Malnutrition and Readmission
A NA study, sponsored by Duke University.
- Completed
- Registry status
- NA
- Development phase
- 38
- Enrollment target
NCT01947166: Completed NA study, sponsored by Duke University.
NCT01947166 is a NA study that has completed, run by Duke University. The registered enrollment target is 38 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01947166, a NA study, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- NA
- Development phase
- 38 participants
- Enrollment target
Study Summary
The Whipple procedure is associated with increased readmission rates for infection, pancreatic leak, and failure to thrive/malnutrition. The purpose of this study is to develop an evidence based perioperative nutrition plan to improve patient outcomes. The study has two specific aims including evaluation of feasibility of implementing an evidence based perioperative nutritional plan for patients undergoing Whipple and evaluation of impact of a standard perioperative nutritional plan on primary outcome of readmission rate and secondary outcomes of readmission cause, length of stay for initial hospitalization and/or readmission, post surgical complications (surgical site infections, pancreatic leak, sepsis, delayed gastric emptying), and nutritional status (PG-Subject Generated Assessment scores, BMI, albumin, pre-albumin, and method of oral intake). Categorical variables including readmission rate, readmission cause, post-surgical complications and nutritional status will be compared by chi-square test between intervention and control group. Length of stay for initial hospitalization and readmission will be compared by non parametric Wilcoxon test between two groups. Descriptive statistics will be used to describe the sample. There are no risks to the study participants.
Primary Outcome
Evaluate the feasibility of implementing an evidence based perioperative nutritional plan for patients undergoing Whipple by outcomes of: 1)admission rates, 2) admission causes 3)percentage of adherence to nutritional protocol 4) length of stay 5) reported symptoms (nausea, vomiting, diarrhea), 6) postsurgical complications 7) nutritional status preoperative visit between days 2 - 5 postoperatively, on the day of discharge, and at follow up visits at weeks 1, 3 and 6.
Interventions
- DIETARY_SUPPLEMENT Nestle Impact Advanced Recovery nutritional supplement
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2013-12 |
| Est. Completion | 2016-06 |
| Phase | NA |
What the finished NCT01947166 record still lists
NCT01947166 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 38 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 1 intervention - of which Nestle Impact Advanced Recovery nutritional supplement is the first listed.
NCT01947166 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01947166 about?
NCT01947166 is a clinical study titled "Pancreatic Resection, Malnutrition and Readmission". The Whipple procedure is associated with increased readmission rates for infection, pancreatic leak, and failure to thrive/malnutrition. The purpose of this study is to develop an evidence based perioperative nutrition plan to improve patient outcomes. The study has two specific aims including evalu...
What is the current status of trial NCT01947166?
This trial is currently completed. It is a NA study. The enrollment target is 38 participants. The study started on 2013-12. Estimated completion is 2016-06.
What interventions are being tested in trial NCT01947166?
The interventions under investigation include: Nestle Impact Advanced Recovery nutritional supplement (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT01947166?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01947166's enrollment target sits among peer trials
38 1538th of 2000 higher than 461 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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