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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 is a NA study that has completed, run by James A. Haley Veterans Administration Hospital. The registered enrollment target is 108 participants.
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
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01471743
The ClinicalTrials.gov registry entry for NCT01471743 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 108 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is James A. Haley Veterans Administration Hospital, which has 7 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Impact Advance Recovery (R) is the first listed.
NCT01471743 reports 0 study locations.
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.
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