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NCT01471743 · ClinicalTrials.gov registry record · NA
GI Surgery Pre-Operative Nutrition
A NA study, sponsored by James A. Haley Veterans Administration Hospital.
- Completed
- Registry status
- NA
- Development phase
- 108
- Enrollment target
NCT01471743: Completed NA study, sponsored by James A. Haley Veterans Administration Hospital.
NCT01471743 is a NA study that has completed, run by James A. Haley Veterans Administration Hospital. The registered enrollment target is 108 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01471743, a NA study, has completed, sponsored by James A. Haley Veterans Administration Hospital.
- COMPLETED
- Registry status
- NA
- Development phase
- 108 participants
- Enrollment target
Study Summary
Surgical patients are high risk for post operative infections. These post operative infections contribute to increased length of hospital stay, hospital costs and delay overall recovery time thus decreasing the quality of life. Studies have reported post operative complications ranging from 37% to 74%.1 The most costly complications include infectious complications after major Gastrointestinal (GI) surgery including wound infections, abdominal abscess, pneumonia, sepsis and anastomic leaks.2 Several studies have been conducted that show a significant reduction in infectious complications and average length of stay when treated with immunonutrition supplements.2-3 A review of similarly designed studies in a different patient population indicate that post-operative infections can be reduced by an average of 71% with immunonutrition. This study seeks to investigate the effect of Impact Advanced Recovery ® in improving surgical outcomes in patients receiving major gastrointestinal surgeries compared to a standard supplement at James A. Haley Veterans' Hospital. Providing Impact Advanced Recovery ® may decrease post-operative infectious complications, length of stay, and recovery time. Hypothesis 1. In patients receiving elective gastrointestinal surgery (esophageal, gastric, pancreatic or colon resections) there will be a significant decrease of at least 60% in post-operative infections as listed below for patients who consume 15 servings of Impact Advanced Recovery® pre-operatively compared to patients who consume 15 servings of a standard supplement. Complications to be considered: anastomatic leak, post-op wound development, post-op abdominal abscess, sepsis, pneumonia, post-op ileus, intestinal fistula, obstruction, urinary tract infections, peritonitis or bowel necrosis. 2. In patients receiving elective gastrointestinal surgery (esophageal, gastric, pancreatic or colon resections) there will be a significant decrease in hospital and NPO days for patients wh
Primary Outcome
Determine the effectiveness of pre-operative supplementation with Impact Advanced Recovery ® on reducing the risk of developing complications during the 30 day post-operative period with decreased length of hospital stay, and time to resume an oral diet.
Interventions
- DIETARY_SUPPLEMENT Impact Advance Recovery (R)
- DIETARY_SUPPLEMENT Ensure Plus (R)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 108 participants |
| Start Date | 2011-11 |
| Est. Completion | 2016-02 |
| Phase | NA |
What the finished NCT01471743 record still lists
NCT01471743 is an interventional study that assigns participants to a tested intervention. The registered 108 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 2 interventions - of which Impact Advance Recovery (R) is the first listed.
NCT01471743 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01471743 about?
NCT01471743 is a clinical study titled "GI Surgery Pre-Operative Nutrition". Surgical patients are high risk for post operative infections. These post operative infections contribute to increased length of hospital stay, hospital costs and delay overall recovery time thus decreasing the quality of life. Studies have reported post operative complications ranging from 37% to 7...
What is the current status of trial NCT01471743?
This trial is currently completed. It is a NA study. The enrollment target is 108 participants. The study started on 2011-11. Estimated completion is 2016-02.
What interventions are being tested in trial NCT01471743?
The interventions under investigation include: Impact Advance Recovery (R) (DIETARY_SUPPLEMENT), Ensure Plus (R) (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT01471743?
This trial is sponsored by James A. Haley Veterans Administration Hospital, which has 7 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01471743's enrollment target sits among peer trials
108 825th of 2000 higher than 1,171 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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