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

NCT ID: NCT04014517

Last Updated: 2019-11-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 350 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-01
• Study Completion Date: 2022-10-01

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.

Conditions

Crohn Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

Standard of Care

Intervention Type: OTHER

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

Impact

Group Type: EXPERIMENTAL

Immunonutrition

Intervention Type: DIETARY_SUPPLEMENT

Impact. Patients will be asked to consume 3 cartons/day of Nestle IMPACT for pre-operative 7 days and 1 carton/day of Nestle IMPACT for post-operative 30 days

Interventions

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

Intervention Type: OTHER

Immunonutrition

Impact. Patients will be asked to consume 3 cartons/day of Nestle IMPACT for pre-operative 7 days and 1 carton/day of Nestle IMPACT for post-operative 30 days

Intervention Type: DIETARY_SUPPLEMENT

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istituto Clinico Humanitas

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Antonino Spinelli, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Istituto Clinico Humanitas

Central Contacts

Annalisa Maroli, PhD

Role: CONTACT

annalisa.maroli@humanitas.it

+390282247776

Lara Monti, MS

Role: CONTACT

lara.monti@humanitas.it

+390282244623

Other Identifiers

2019-001

Identifier Type: -

Identifier Source: org_study_id