GI Surgery Pre-Operative Nutrition

James A. Haley Veterans' Hospital

Status: Completed

Conditions: Immunonutrition

Treatments: Dietary Supplement: Ensure Plus (R); Dietary Supplement: Impact Advance Recovery (R)

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT01471743

Pro00002602

Details and patient eligibility

About

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.

Enrollment: 108 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologically documented neoplasm of the gastrointestinal tract.
• Planned major elective surgery including esophageal, gastric, pancreatic or colon resections.

Exclusion criteria

• Critically ill patients defined as any patient admitted to the intensive care unit (ICU) prior to elective surgery.
• Current use of steroids or other immunosuppressive medications.
• History of hospitalization for pulmonary, cardiac or renal disease in the 6 months prior to elective surgery.
• Patients who exhibit signs and symptoms of infection or sepsis including: elevated WBC above 10,000 cells/ml; temperature > 37.7 C

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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108 participants in 2 patient groups

Impact Advance Recovery (R)

Experimental group

Description:

3 supplements per day for 5 days pre-operatively

Treatment:

Dietary Supplement: Impact Advance Recovery (R)

Standard Supplement

Active Comparator group

Description:

3 supplement per day for 5 days pre-operatively

Treatment:

Dietary Supplement: Ensure Plus (R)