Status:
UNKNOWN
Effect of Peri-operative Immunonutrition on Recurrence and Infections in Crohn's Disease Patients
Lead Sponsor:
Istituto Clinico Humanitas
Conditions:
Crohn Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 i...
Detailed Description
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 patient...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2022
Estimated Enrollment :
350 Patients enrolled
Trial Details
Trial ID
NCT04014517
Start Date
March 1 2020
End Date
October 1 2022
Last Update
November 27 2019
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