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


N/A
18 Years
N/A
Open (Enrolling)
Both
Immunonutrition

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Number of participants with post-op Infections

Outcome Description:

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.

Outcome Time Frame:

within 30 days post-operatively

Safety Issue:

No

Authority:

United States: Federal Government

Study ID:

Pro00002602

NCT ID:

NCT01471743

Start Date:

November 2011

Completion Date:

Related Keywords:

  • Immunonutrition
  • nutrition
  • surgery
  • immune

Name

Location

James A. Haley VA HospitalTampa, Florida  33612