GI Surgery Pre-Operative Nutrition

NCT01471743 | Completed DMC

• 1 other identifier: Pro00002602
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief 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. 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.
2. 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

Keywords

nutrition; surgery; immune

Outcome Measures

Primary Outcomes (1)

• 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.

  within 30 days post-operatively

Study Arms (2)

Impact Advance Recovery (R)

EXPERIMENTAL

3 supplements per day for 5 days pre-operatively

Dietary Supplement: Impact Advance Recovery (R)

Standard Supplement

ACTIVE COMPARATOR

3 supplement per day for 5 days pre-operatively

Dietary Supplement: Ensure Plus (R)

Interventions

Impact Advance Recovery (R) DIETARY_SUPPLEMENT

Impact Advance Recovery (R)

Ensure Plus (R) DIETARY_SUPPLEMENT

Standard Supplement

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• James A. Haley Veterans Administration Hospital: lead

Study Sites (1)

James A. Haley VA Hospital

Tampa, Florida, 33612, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Clinical Nutrition

Study Record Dates

• First Submitted: November 9, 2011
• First Posted: November 16, 2011
• Study Start: November 1, 2011
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: February 23, 2016

Record last verified: 2016-02

Locations

US (1)