An interventional study of Impact Advance Recovery (R) and Ensure Plus (R) in Immunonutrition, sponsored by James A. Haley Veterans Administration Hospital. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-02-23.
Sponsored by James A. Haley Veterans Administration Hospital · Not applicable, Interventional, and Supportive care
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
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.
James A. Haley Veterans Administration Hospital is the lead sponsor of 7 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
3 supplements per day for 5 days pre-operatively
Dietary Supplement: Impact Advance Recovery (R)
3 supplement per day for 5 days pre-operatively
Dietary Supplement: Ensure Plus (R)
Number of participants with post-op Infections
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.
Time frame: within 30 days post-operatively
This study is completed, as verified in Feb 2016. You cannot join it, but the record below documents what was studied.
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James A. Haley Veterans Administration Hospital