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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nutrition specialist | Experimental | Participants will be assigned to this arm if the subject is determined malnourished. They will be sent to a nutrition specialist for a nutrition focused visit and will be provided standard of care intervention prior surgery. |
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| Standard of Care | Active Comparator | Participants that show no signs of malnutrition will be assigned to this arm. The subject will be provided with education and schedule of Ensure® Surgery Immunonutrition shakes for prior to surgery as per standard of care. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nutrition specialist | Other | Nutrition specialist to help improve nutritional status by diet, oral nutrition supplements or parenteral nutrition. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Length of hospital stay | From the time the patient is admitted at hospital for surgery until the patient is discharged. | 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). | Visit 3 (30 days post-surgery) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jennifer Katz, MD | Contact | (855) 698-4232 | Jennifer.katz@nyulangone.org |
| Name | Affiliation | Role |
|---|---|---|
| Jennifer Katz, MD | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Langone Health | Recruiting | New York | New York | 10016 | United States |
The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: Jennifer.katz@nyulangone.org. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
The investigator who proposed to use the data will be provided access upon reasonable request. Requests should be directed to Jennifer.katz@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.
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| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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| Ensure Surgery Immunonutrition shakes | Dietary Supplement | 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. |
|
| 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 | Subject will be called the day prior to surgery to determine the number of shakes consumed by patient. | 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. | One week post surgery |
| 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 |