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

NCT06309017 | Recruiting

• 1 other identifier: 23-01243
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Inflammatory Bowel Diseases

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (8)

• 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

Study Arms (2)

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.

Other: Nutrition specialist; Dietary Supplement: Ensure Surgery Immunonutrition shakes

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.

Dietary Supplement: Ensure Surgery Immunonutrition shakes

Interventions

Nutrition specialist OTHER

Nutrition specialist to help improve nutritional status by diet, oral nutrition supplements or parenteral nutrition.

Nutrition specialist

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.

Nutrition specialist; Standard of Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• No current diagnosis of inflammatory bowel disease
• Age less than 18
• Not proficient (able to read and answer questions) in English

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

RECRUITING

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Jennifer Katz, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jennifer Katz, MD

CONTACT

(855) 698-4232; Jennifer.katz@nyulangone.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2024
• First Posted: March 13, 2024
• Study Start: January 7, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: March 5, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• 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.
• 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.

Locations

US (1)