Effect of Peri-operative Immunonutrition on Recurrence and Infections in Crohn's Disease Patients

Effect of Peri-operative Immunonutrition on Recurrence and Infections in Crohn's Disease Patients

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.

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.

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.