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Clinical Trial Summary

The optimalisation of the health status of patients scheduled for major surgery has been considered to be the most important point of perioperative care, and nutritional intervention has been perceived a key point of that intervention. Immunomodulating diets were thought to reduce cmplications, hoever recent studies put that opnion in doubt. This study was designed to assess the actual clinical significance of oral immunonutrition.


Clinical Trial Description

The optimalisation of the health status of patients scheduled for major surgery has been considered to be the most important point of perioperative care, and nutritional intervention has been perceived a key point of that intervention. Italian studies followed by metanalyses demonstrated the superiority of immunomodulating diets (IM) over any other preoperative nutrition, hence the surgical guidelines for enteral nutrition published by European Society for Clinical Nutrition and Metabolism (ESPEN) in 2006 recommended to use IM for 7-14 days preoperatively in all patients undergoing major surgeries. Some authors questioned IM by showing no benefit of IM over standard enteral nutrition. Other authors observed similar results.The debate was far from being over - in 2015 a new metanalysis stated that perioperative enteral nutrition is the best option for managing clinical status of patients who underwent selective surgery for gastrointestinal cancer. One year later, ESPEN changed its surgical recommendations and advised to use IM preoperatively in malnourished and perioperatively in well-nourished patients. American recommendations remained unchanged and, according to them, it is advised to use IM preoperatively in all surgical patients, however, high-protein nutrition could also be an beneficial option. To address those doubts and to assess the actual clinical significance of oral immunonutrition, a randomized, two center, prospective clinical trial was conducted. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05069402
Study type Interventional
Source Stanley Dudrick's Memorial Hospital
Contact Stanislaw Klek, PhD
Phone +48604293566
Email [email protected]
Status Recruiting
Phase N/A
Start date September 1, 2021
Completion date March 31, 2023

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