GI Surgery Pre-Operative Nutrition

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2016-02-29

Brief Summary

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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.

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Detailed Description

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Conditions

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Immunonutrition

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Impact Advance Recovery (R)

3 supplements per day for 5 days pre-operatively

Group Type EXPERIMENTAL

Impact Advance Recovery (R)

Intervention Type DIETARY_SUPPLEMENT

Standard Supplement

3 supplement per day for 5 days pre-operatively

Group Type ACTIVE_COMPARATOR

Ensure Plus (R)

Intervention Type DIETARY_SUPPLEMENT

Interventions

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Impact Advance Recovery (R)

Intervention Type DIETARY_SUPPLEMENT

Ensure Plus (R)

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No