NCT01471743

GI Surgery Pre-Operative Nutrition

The Effect of Pre-Operative Immunonutrition With "Impact Advanced Recovery (R)" on Patients Undergoing Major GI Cancer Surgery

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 108 (actual)
• Sponsor: James A. Haley Veterans Administration Hospital · Federal
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 who consume 15 servings of Impact Advanced Recovery ® pre-operatively.

Conditions

• Immunonutrition

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Impact Advance Recovery (R)
DIETARY_SUPPLEMENT	Ensure Plus (R)

Timeline

• Start date: 2011-11-01
• Primary completion: 2016-02-01
• Completion: 2016-02-01
• First posted: 2011-11-16
• Last updated: 2016-02-23

Locations

1 site across 1 country: United States