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Impact of Various Diets on Surgical Complications

Impact of Immunomodulating Oral Nutrition on Surgical Complications

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05069402
Acronym
IMM4
Enrollment
300
Registered
2021-10-06
Start date
2021-09-01
Completion date
2025-12-31
Last updated
2026-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Complication,Postoperative

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.

Interventions

DIETARY_SUPPLEMENTImmunonutrition

diet with immunonutrients

DIETARY_SUPPLEMENTHigh-protein

Oral nutrition with high-protein content

DIETARY_SUPPLEMENTStandard ONS

Oral nutrition with standard ingredients

Sponsors

Stanley Dudrick's Memorial Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)

Masking description

The physician is unaware of the type of the intervention. The type of intervention is given by the independent person to dietitian instructing the patient how to use the product.

Intervention model description

randomisation into 4 arms

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Surgical complications6 monthsNumber and type of surgical complications
Infectious complications6 monthsNumber and type of infectious complications

Secondary

MeasureTime frameDescription
Length of stay6 monthsDays of hospital stay after the operation

Countries

Poland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026