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OpenTrials
Completed

NCT Number: NCT01471743

GI Surgery Pre-Operative Nutrition

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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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

James A. Haley VA Hospital

Tampa, Florida, 33612, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Impact Advance Recovery (R)

Dietary Supplement

Ensure Plus (R)

Dietary Supplement

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

James A. Haley Veterans Administration Hospital

Fed

Registry information

Official study title

The Effect of Pre-Operative Immunonutrition With "Impact Advanced Recovery (R)" on Patients Undergoing Major GI Cancer Surgery

Important dates

Study start
2011
Primary completion
2016
Study completion
2016
First posted
Nov 16, 2011
Registry last updated
Feb 23, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.