Impact of Various Diets on Surgical Complications

NCT ID: NCT05069402

Last Updated: 2026-01-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-01
• Study Completion Date: 2025-12-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Immunonutrition

Oral immunonutrition containing arginine, omega-PUFAs and antioxidants

Group Type: EXPERIMENTAL

Immunonutrition

Intervention Type: DIETARY_SUPPLEMENT

diet with immunonutrients

High-protein diet

Oral nutrition with high-protein content

Group Type: ACTIVE_COMPARATOR

High-protein

Intervention Type: DIETARY_SUPPLEMENT

Oral nutrition with high-protein content

Standard nutrition

Oral nutrition with standard components

Group Type: ACTIVE_COMPARATOR

Standard ONS

Intervention Type: DIETARY_SUPPLEMENT

Oral nutrition with standard ingredients

Interventions

Standard ONS

Oral nutrition with standard ingredients

Intervention Type: DIETARY_SUPPLEMENT

High-protein

Oral nutrition with high-protein content

Intervention Type: DIETARY_SUPPLEMENT

Immunonutrition

diet with immunonutrients

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• no sign of malnutrition (defined as one of the following unintentional weight loss by at least 10% or body mass index (BMI) < 18),
• good general status (Karnofsky Performance Index > 80,
• Eastern Cooperative Oncology Group (ECOG) grade 0 or 1);
• no confirmed neoplastic dissemination no severe concomitant disease (heart, lung, kidney, liver failure, chronic obstructive pulmonary disease [COPD], coronary aortic bypass graft [CABG], etc.),
• no history of known allergies or drug intolerance to analyzed substances.

Exclusion Criteria

• Patients malnourished or with metastatic disease,
• pregnant,
• in poor general status (Karnofsky <80, Eastern Cooperative Oncology Group (ECOG) > 1),
• recent history of severe heart, lung, kidney or liver failure,
• history of allergies or drug intolerance

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

Sponsors

Stanley Dudrick's Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Stanislaw Klek

Head of the Unit

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stanislaw Klek, PhD

Role: PRINCIPAL_INVESTIGATOR

Stanley Dudrick's Memorial Hospital

Locations

Narodowy Instytut Onkologii

Krakow, Malopolska, Poland

Stanley Dudrick's Memorial Hospital

Skawina, Malopolska, Poland

Countries

Poland

Other Identifiers

4armsimmuno

Identifier Type: -

Identifier Source: org_study_id