The Effect of Pre-Operative Immunonutrition With "Impact Advanced Recovery (R)" on Patients Undergoing Major GI Cancer Surgery
N/A
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Both
Immunonutrition
Both
Immunonutrition
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 Hospital | Tampa, Florida 33612 |
