Clinical trial NCT04014517: Effect of Peri-operative Immunonutrition on Recurrence and Infections in Crohn's Disease Patients
Official title: Effect of Peri-operative Immunonutrition on Recurrence and Infections in Crohn's Disease Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Crohn Disease
Keywords: Inflammatory Bowel Diseases
Crohn's Disease
Immunonutrition
Lead sponsor: Istituto Clinico Humanitas
Sponsor class: OTHER
First posted: 2019-07-10
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 is to assess the effectiveness of immunonutrition therapy in decreasing the rate of post-operative infective complications and 6 months endoscopic disease recurrence.

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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Post-operative infective complications rate
timeFrame: 30 days post-operatively
measure: 6 months endoscopic recurrence
timeFrame: 6 months post-operatively
Secondary outcomes:
measure: 6 months nutritional status
timeFrame: 6 months post-operatively
measure: 30 days quality of life
timeFrame: 30 days post-operatively
measure: 90 days quality of life
timeFrame: 90 days post-operatively
measure: 6 months quality of life
timeFrame: 6 months post-operatively
Other outcomes:
Locations:
Study officials:
affiliation: Istituto Clinico Humanitas
name: Antonino Spinelli, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: