GI Surgery Pre-Operative Nutrition

Immunonutrition Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01471743
• Other study ID #: Pro00002602
• Status: Completed
• Phase: N/A
• First received: November 9, 2011
• Last updated: February 22, 2016
• Start date: November 2011
• Est. completion date: February 2016

Study information

• Verified date: February 2016
• Source: James A. Haley Veterans Administration Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Immunonutrition

Intervention

Dietary Supplement:
• Impact Advance Recovery (R)

• Ensure Plus (R)

Locations

Country	Name	City	State
United States	James A. Haley VA Hospital	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
James A. Haley Veterans Administration Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No