This study aims to determine if improved risk stratification tools and interventions to mitigate malnutrition reduce postoperative risk in patients undergoing elective or emergent resection surgery for inflammatory bowel disease (IBD), and if adding immune modulation nutrition improves surgical outcomes. The primary objective is to assess whether preoperative malnutrition screening and intervention minimize postoperative complications. The secondary objective is to evaluate whether immune modulation nutrition in the peri-operative period decreases length of stay and major complications.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
150
Nutrition specialist to help improve nutritional status by diet, oral nutrition supplements or parenteral nutrition.
All study subjects, including subjects without malnutrition, will be given the Ensure Surgery Immunonutrition Shakes for prior to surgery as per standard of care. All subjects will also receive additional shakes starting as an inpatient when diet is advanced.
NYU Langone Health
New York, New York, United States
RECRUITINGLength of hospital stay
From the time the patient is admitted at hospital for surgery until the patient is discharged.
Time frame: Up to 30 days post-surgery
Proportion of patients who experienced postoperative major complications
Major complications include infection, bleeding (requiring blood transfusion or requiring intervention), cardiac event (myocardial infarction, arrhythmia, and cardiac arrest), stroke, acute kidney injury (increase in serum creatinine of ≥0.3 mg/dL from baseline or ≥1.5 times baseline), venous thromboembolism, reoperation, readmission, and need for ICU-level care. The outcome measure will be obtained from the electronic health record (EHR).
Time frame: Visit 3 (30 days post-surgery)
Proportion of patients who participated in a nutritional intervention program before surgery
Time frame: Visit 3 (30 days post-surgery)
Proportion of patients who participated in a nutritional intervention program after surgery
Time frame: Visit 3 (30 days post-surgery)
Number of nutritional shakes completed
Time frame: Visit 3 (30 days post-surgery)
Percentage of nutritional shakes completed overall
Time frame: Visit 3 (30 days post-surgery)
Percentage of nutritional shakes completed pre-surgery
Subject will be called the day prior to surgery to determine the number of shakes consumed by patient.
Time frame: One day prior to surgery
Percentage of nutritional shakes completed post-surgery
One week after surgery, a phone call will follow to determine how many shakes subject consumed.
Time frame: One week post surgery
Proportion of patients who experienced any postoperative complications
Time frame: Visit 3 (30 days post-surgery)
Proportion of patients with 30 day readmission
Time frame: Up to 30 days post-surgery
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