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GI Surgery Pre-Operative Nutrition

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01471743
First Posted: November 16, 2011
Last Update Posted: February 23, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Sherri L Lewis, James A. Haley Veterans Administration Hospital
  Purpose

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.

Condition Intervention
Immunonutrition Dietary Supplement: Impact Advance Recovery (R) Dietary Supplement: Ensure Plus (R)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: The Effect of Pre-Operative Immunonutrition With "Impact Advanced Recovery (R)" on Patients Undergoing Major GI Cancer Surgery

Further study details as provided by Sherri L Lewis, James A. Haley Veterans Administration Hospital:

Primary Outcome Measures:
  • Number of participants with post-op Infections [ Time Frame: within 30 days post-operatively ]
    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.


Enrollment: 108
Study Start Date: November 2011
Study Completion Date: February 2016
Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Impact Advance Recovery (R)
3 supplements per day for 5 days pre-operatively
Dietary Supplement: Impact Advance Recovery (R)
Active Comparator: Standard Supplement
3 supplement per day for 5 days pre-operatively
Dietary Supplement: Ensure Plus (R)

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01471743


Locations
United States, Florida
James A. Haley VA Hospital
Tampa, Florida, United States, 33612
Sponsors and Collaborators
James A. Haley Veterans Administration Hospital
  More Information

Responsible Party: Sherri L Lewis, Chief, Clinical Nutrition, James A. Haley Veterans Administration Hospital
ClinicalTrials.gov Identifier: NCT01471743     History of Changes
Other Study ID Numbers: Pro00002602
First Submitted: November 9, 2011
First Posted: November 16, 2011
Last Update Posted: February 23, 2016
Last Verified: February 2016

Keywords provided by Sherri L Lewis, James A. Haley Veterans Administration Hospital:
nutrition
surgery
immune


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