NCT05069402

Impact of Various Diets on Surgical Complications

Impact of Immunomodulating Oral Nutrition on Surgical Complications

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (actual)
• Sponsor: Stanley Dudrick's Memorial Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Complication,Postoperative

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Immunonutrition	diet with immunonutrients
DIETARY_SUPPLEMENT	High-protein	Oral nutrition with high-protein content
DIETARY_SUPPLEMENT	Standard ONS	Oral nutrition with standard ingredients

Timeline

• Start date: 2021-09-01
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2021-10-06
• Last updated: 2026-01-13

Locations

2 sites across 1 country: Poland