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Clinical Trial 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.


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT04014517
Study type Interventional
Source Istituto Clinico Humanitas
Contact Annalisa Maroli, PhD
Phone +390282247776
Email annalisa.maroli@humanitas.it
Status Not yet recruiting
Phase N/A
Start date March 1, 2020
Completion date October 1, 2022

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