Pre-operative Nutrition for Elective Resection Surgery in Inflammatory Bowel Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Nutrition specialist, Ensure Surgery Immunonutrition shakes.
- Who it may be relevant to
- Registry conditions: Inflammatory Bowel Diseases. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- 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.
Primary outcome measures
- Length of hospital stay [Time frame: Up to 30 days post-surgery]
- Proportion of patients who experienced postoperative major complications [Time frame: Visit 3 (30 days post-surgery)]
Secondary outcome measures (8)
- 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]
- Percentage of nutritional shakes completed post-surgery [Time frame: One week post surgery]
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- NYU Langone Health — New York
Identifiers
NCT: NCT06309017 · 23-01243