Inflammatory Bowel Diseases
Conditions
Brief summary
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.
Interventions
OTHERNutrition specialist
Nutrition specialist to help improve nutritional status by diet, oral nutrition supplements or parenteral nutrition.
DIETARY_SUPPLEMENTEnsure Surgery Immunonutrition shakes
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.
Sponsors
NYU Langone Health
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Able and willing to provide written informed consent 2. Aged 18 years of age or older 3. Confirmed diagnosis of inflammatory bowel disease 4. Scheduled for disease-related intestinal resection at NYU Langone Health
Exclusion criteria
1. No current diagnosis of inflammatory bowel disease 2. Age less than 18 3. Not proficient (able to read and answer questions) in English
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Length of hospital stay | Up to 30 days post-surgery | From the time the patient is admitted at hospital for surgery until the patient is discharged. |
| Proportion of patients who experienced postoperative major complications | Visit 3 (30 days post-surgery) | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients who participated in a nutritional intervention program before surgery | Visit 3 (30 days post-surgery) | — |
| Proportion of patients who participated in a nutritional intervention program after surgery | Visit 3 (30 days post-surgery) | — |
| Number of nutritional shakes completed | Visit 3 (30 days post-surgery) | — |
| Percentage of nutritional shakes completed overall | Visit 3 (30 days post-surgery) | — |
| Percentage of nutritional shakes completed pre-surgery | One day prior to surgery | Subject will be called the day prior to surgery to determine the number of shakes consumed by patient. |
| Percentage of nutritional shakes completed post-surgery | One week post surgery | One week after surgery, a phone call will follow to determine how many shakes subject consumed. |
| Proportion of patients who experienced any postoperative complications | Visit 3 (30 days post-surgery) | — |
| Proportion of patients with 30 day readmission | Up to 30 days post-surgery | — |
Countries
United States
Contacts
CONTACTJennifer Katz, MD
PRINCIPAL_INVESTIGATORJennifer Katz, MD
NYU Langone Health
Outcome results
None listed