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

Not Applicable

• Conditions: Crohn Disease
• Interventions: Other: Standard of Care; Dietary Supplement: Immunonutrition

• Registration Number: NCT04014517
• Lead Sponsor: Istituto Clinico Humanitas

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.

Study Timeline

• Study First Submitted: 2019-07-08
• Study First Submitted QC: 2019-07-08
• Study First Posted: 2019-07-10
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-25
• Last Update Posted: 2019-11-27
• Study Start: 2020-03-01
• Primary Completion: 2022-03-01
• Study Completion: 2022-10-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 350

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard of Care	Standard of Care	Standard of Care is represented by the best standard peri-operative treatment already planned for the study population: as for ERAS guidelines, it is represented by fast restoration of liquid and solid diet after surgery (approximately 24 hours after surgery) and pre-operative and post-operative dietary counselling whenever indicated by the surgeon or gastroenterologist
Immunonutrition	Immunonutrition	Impact

Primary Outcome Measures

Name	Time	Method
Post-operative infective complications rate	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	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).

Secondary Outcome Measures

Name	Time	Method
90 days quality of life	90 days post-operatively	Quality of Life will be evaluated trhough the Short-Inflammatory Bowel Disease Quality of Life questionnaire (S-IBDQoL), which is 10-item questionnaire. All items are reported in a 7 point scale, from "all of the time" to "none of the time" (1 = poor health; 7 = good health).
6 months nutritional status	6 months post-operatively	Nutritional status will be evaluated through the Malnutrition Universal Screening Tool (MUST). MUST consists of three different levels, generating a risk predictor ranging from 0 (low risk) to 2 (high risk), considering the calculated Body Mass Index (BMI), the unintentional weight loss and the pathological conditions of the patient.
6 months quality of life	6 months post-operatively	Quality of Life will be evaluated trhough the Short-Inflammatory Bowel Disease Quality of Life questionnaire (S-IBDQoL), which is 10-item questionnaire. All items are reported in a 7 point scale, from "all of the time" to "none of the time" (1 = poor health; 7 = good health).
30 days quality of life	30 days post-operatively	Quality of Life will be evaluated trhough the Short-Inflammatory Bowel Disease Quality of Life questionnaire (S-IBDQoL), which is 10-item questionnaire. All items are reported in a 7 point scale, from "all of the time" to "none of the time" (1 = poor health; 7 = good health).