Effect of Peri-operative Immunonutrition on Recurrence and Infections in Crohn's Disease Patients
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 350
- 主要终点
- Post-operative infective complications rate
研究概览
简要总结
This is an interventional randomized ope-label two-arm trial on the peri-operative use of immunonutrition in Crohn's Disease (CD) patients undergoing colorectal elective surgery.The aim of the trial is to assess the effectiveness of immunonutrition therapy in decreasing the rate of post-operative infective complications and 6 months endoscopic disease recurrence.
详细描述
Crohn's Disease (CD) patients undergoing abdominal surgery are at high risk to develop post-operative surgical and medical infective complications. Infective complications affect almost 24% of patients. Post-surgical disease recurrence afflicts 35-85% of CD patients in the first year after surgery. Immunonutrition has been successfully applied to surgical patients in several randomized trials, demonstrating a decreased rate of post-operative infective complications. The aim of the study is to compare the incidence of surgical and medical post-operative infective complications and six months endoscopic and clinical disease recurrence (DR) in CD patients receiving immunonutrition in the peri-operative setting compared to patients treated as for standard of care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Patients > 18 years old, females or males;
- •Established Crohn's Disease at the time of surgery indication;
- •Patients scheduled for elective open or minimally invasive bowel resection or strictureplasty;
- •Patients planned for concomitant perianal surgery for CD-related perianal disease can be included in the study.
排除标准
- •Patients < 18 years old;
- •Pregnant or breastfeeding women;
- •Diagnosis of undetermined colitis;
- •Concomitant diagnosis of malignancy;
- •Established malnutrition, according to clinical definition, requiring nutritional intervention;
- •Patients with more than two criteria for high risk of recurrence among the following: previous abdominal resection, penetrating disease phenotype or active smoking;
- •Any condition that, in the opinion of the investigator, can interfere with the consent procedure or the conduction of the trial;
- •Patients known to have allergic history to any component of the investigational product;
- •Patient with liver and kidney dysfunction (alanine aminotransferase ALT ≥ 2 times the upper limit of normal; total bilirubin TBIL ≥ 2 times the upper limit of normal; creatinine Cr ≥ 2 times the upper limit of normal);
- •Patients diagnosed with diabetes or fasting blood glucose≥ 10mmol/L;
- •Planned recovery shorter than 48 hours;
- •Surgery in emergency setting;
- •Any concomitant surgery not related to CD or perianal CD.
结局指标
主要结局
Post-operative infective complications rate
时间窗: 30 days post-operatively
Post-operative infective complications rate (including intra-abdominal septic complications, surgical site infections and medical inflections) will be evaluated with clinical, radiological and molecular analysis
6 months endoscopic recurrence
时间窗: 6 months post-operatively
Endoscopic recurrence will be evaluated through colonoscopy with or without biopsies and Rutgeert score. Rutgeert score is an endoscopic risk score intended to predict disease recurrence: it is calculated depending on the number and type of intestinal lesions and consists of five level of disease recurrence risk, from 0 (endoscopic remission) to 4 (advanced disease recurrence).
次要结局
- 90 days quality of life(90 days post-operatively)
- 6 months nutritional status(6 months post-operatively)
- 6 months quality of life(6 months post-operatively)
- 30 days quality of life(30 days post-operatively)