Pre-operative Nutrition for Elective Resection Surgery in Inflammatory Bowel Disease

Not Applicable

Recruiting

• Conditions: Inflammatory Bowel Diseases
• Interventions: Other: Nutrition specialist; Dietary Supplement: Ensure Surgery Immunonutrition shakes

• Registration Number: NCT06309017
• Lead Sponsor: NYU Langone Health

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-03-07
• Study First Submitted QC: 2024-03-07
• Study First Posted: 2024-03-13
• Study Start: 2025-01-07
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-09
• Last Update Posted: 2025-04-11
• Primary Completion: 2027-01
• Study Completion: 2027-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nutrition specialist	Nutrition specialist	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.
Nutrition specialist	Ensure Surgery Immunonutrition shakes	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.
Standard of Care	Ensure Surgery Immunonutrition shakes	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Proportion of patients with 30 day readmission	Up to 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)
Proportion of patients who participated in a nutritional intervention program before surgery	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.
Proportion of patients who experienced any postoperative complications	Visit 3 (30 days post-surgery)
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.

Trial Locations

Locations (1)

NYU Langone Health; 🇺🇸 New York, New York, United States