NYU Langone Health
New York, 10016, United States
Location status: Recruiting
Recruiting
NCT Number: NCT06309017
Pre-operative Nutrition for Elective Resection Surgery in Inflammatory Bowel Disease
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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Able and willing to provide written informed consent
- Aged 18 years of age or older
- Confirmed diagnosis of inflammatory bowel disease
- Scheduled for disease-related intestinal resection at NYU Langone Health
Exclusion criteria
- No current diagnosis of inflammatory bowel disease
- Age less than 18
- Not proficient (able to read and answer questions) in English
Treatment and study plan
Nutrition specialist
OtherNutrition specialist to help improve nutritional status by diet, oral nutrition supplements or parenteral nutrition.
Ensure Surgery Immunonutrition shakes
Dietary SupplementAll 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.
Primary outcomes
-
Length of hospital stay
Time frame: 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
Time frame: 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 outcomes
-
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
Time frame: 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
Time frame: 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
Time frame: Visit 3 (30 days post-surgery)
-
Proportion of patients with 30 day readmission
Time frame: Up to 30 days post-surgery
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
NYU Langone Health
Other
Registry information
Important dates
- Study start
- 2025
- Primary completion
- 2027
- Study completion
- 2027
- First posted
- Mar 13, 2024
- Registry last updated
- Mar 5, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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