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.

Study Overview

• Status: Recruiting
• Conditions: Inflammatory Bowel Diseases
• Intervention / Treatment: Other: Nutrition specialist; Dietary supplement: Ensure Surgery Immunonutrition shakes

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jennifer Katz, MD; Phone Number: (855) 698-4232; Email: Jennifer.katz@nyulangone.org

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • Recruiting
      • NYU Langone Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: Nutrition specialist; Nutrition specialist to help improve nutritional status by diet, oral nutrition supplements or parenteral nutrition.; Dietary supplement: Ensure 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.
Active Comparator: Standard of Care; 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.	Dietary supplement: Ensure 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Secondary Outcome Measures

Outcome Measure	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)
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

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Jennifer Katz, MD, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Actual): January 7, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): July 1, 2027

Study Registration Dates

• First Submitted: March 7, 2024
• First Submitted That Met QC Criteria: March 7, 2024
• First Posted (Actual): March 13, 2024

Study Record Updates

• Last Update Posted (Actual): March 5, 2026
• Last Update Submitted That Met QC Criteria: March 4, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Inflammatory Bowel Diseases
• Other Study ID Numbers: 23-01243

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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
• IPD Sharing Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• IPD Sharing Access Criteria: 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No