GI Surgery Pre-Operative Nutrition

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2011 by James A. Haley Veterans Administration Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Sherri L Lewis, James A. Haley Veterans Administration Hospital
ClinicalTrials.gov Identifier:
NCT01471743
First received: November 9, 2011
Last updated: November 10, 2011
Last verified: November 2011
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by James A. Haley Veterans Administration Hospital:

Primary Outcome Measures:
  • Number of participants with post-op Infections [ Time Frame: within 30 days post-operatively ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 108
Study Start Date: November 2011
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Impact Advance Recovery (R) Dietary Supplement: Impact Advance Recovery (R)
Active Comparator: Standard Supplement Dietary Supplement: Ensure Plus (R)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: November 9, 2011
Last Updated: November 10, 2011
Health Authority: United States: Federal Government

Keywords provided by James A. Haley Veterans Administration Hospital:
nutrition
surgery
immune

ClinicalTrials.gov processed this record on September 18, 2014