Pre-operative Nutrition for Elective Resection Surgery in Inflammatory Bowel Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Length of hospital stay
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •No current diagnosis of inflammatory bowel disease
- •Age less than 18
- •Not proficient (able to read and answer questions) in English
研究组 & 干预措施
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.
干预措施: Nutrition specialist (Other)
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.
干预措施: Ensure Surgery Immunonutrition shakes (Dietary Supplement)
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.
干预措施: Ensure Surgery Immunonutrition shakes (Dietary Supplement)
结局指标
主要结局
Length of hospital stay
时间窗: 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
时间窗: 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).
次要结局
- 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)
- 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)