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

Inflammatory Bowel Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06309017
• Other study ID #: 23-01243
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 10, 2024
• Est. completion date: April 2025

Study information

• Verified date: March 2024
• Source: NYU Langone Health
• Contact: Jennifer Katz, MD
• Phone: (855) 698-4232
• Email: Jennifer.katz[@]nyulangone.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: April 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Inflammatory Bowel Diseases
• Intestinal Diseases

Intervention

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.

Locations

Country	Name	City	State
United States	NYU Langone Health	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Proportion of patients who participated in a nutritional intervention program before surgery		Visit 3 (30 days post-surgery)
Secondary	Proportion of patients who participated in a nutritional intervention program after surgery		Visit 3 (30 days post-surgery)
Secondary	Number of nutritional shakes completed		Visit 3 (30 days post-surgery)
Secondary	Percentage of nutritional shakes completed overall		Visit 3 (30 days post-surgery)
Secondary	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
Secondary	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
Secondary	Proportion of patients who experienced any postoperative complications		Visit 3 (30 days post-surgery)
Secondary	Proportion of patients with 30 day readmission		Up to 30 days post-surgery