Complication,PostoperativeIMM4NCT05069402
Impact of Various Diets on Surgical Complications
A study testing Immunonutrition, High-protein and Standard ONS in people with Complication,Postoperative, run by Stanley Dudrick's Memorial Hospital at 2 sites in Poland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Complication,Postoperative
- What is being tested?
- Immunonutrition, High-protein and Standard ONS
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 2 sitesPoland
- Study dates
- 1 Sep 2021to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Poland2 sites
Narodowy Instytut Onkologii
Krakow, Malopolska, 31-115
Stanley Dudrick's Memorial Hospital
Skawina, Malopolska, 32-050
About this study
Official title: Impact of Immunomodulating Oral Nutrition on Surgical Complications
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.
Read the 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
- Being tested
- Immunonutrition, High-protein, Standard ONS
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImmunonutritionDietary supplement
diet with immunonutrients
High-proteinDietary supplement
Oral nutrition with high-protein content
Standard ONSDietary supplement
Oral nutrition with standard ingredients
| Study group | Role | What they receive |
|---|---|---|
| Immunonutrition | Experimental | Oral immunonutrition containing arginine, omega-PUFAs and antioxidants Receives: Dietary Supplement: Immunonutrition |
| High-protein diet | Active comparator | Oral nutrition with high-protein content Receives: Dietary Supplement: High-protein |
| Standard nutrition | Active comparator | Oral nutrition with standard components Receives: Dietary Supplement: Standard ONS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical complications
Number and type of surgical complications
Measured: 6 months
Infectious complications
Number and type of infectious complications
Measured: 6 months
Secondary outcomes (1)
Length of stay
Days of hospital stay after the operation
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2021
- Study start1 Sep 2021
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complication,PostoperativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomisation into 4 arms
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanley Dudrick's Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stanislaw Klek, Stanley Dudrick's Memorial Hospital
- Investigators
- Stanislaw Klek, PhD, Principal investigator, Stanley Dudrick's Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05069402
- Sponsor's protocol ID
- 4armsimmuno
- Acronym
- IMM4
- Status last verified
- Oct 2021
- First submitted
- 25 Sep 2021
- Last updated
- 13 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Immunomodulating Oral Nutrition on Surgical Complications
- ClinicalTrials.gov ID
- NCT05069402
- Acronym / sponsor ID
- IMM4 / 4armsimmuno
- Conditions
- Complication,Postoperative
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Stanley Dudrick's Memorial HospitalUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 6 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- randomisation into 4 arms
| Arm | Type | Receives |
|---|---|---|
| Immunonutrition | Experimental | Dietary Supplement: ImmunonutritionOral immunonutrition containing arginine, omega-PUFAs and antioxidants |
| High-protein diet | Active comparator | Dietary Supplement: High-proteinOral nutrition with high-protein content |
| Standard nutrition | Active comparator | Dietary Supplement: Standard ONSOral nutrition with standard components |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immunonutritiondiet with immunonutrients | Dietary supplement | Immunonutrition |
| High-proteinOral nutrition with high-protein content | Dietary supplement | High-protein diet |
| Standard ONSOral nutrition with standard ingredients | Dietary supplement | Standard nutrition |
Primary outcome
Surgical complications
Time frame: 6 months
Number and type of surgical complications
Infectious complications
Time frame: 6 months
Number and type of infectious complications
1 secondary outcome
Length of stay
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2026.
- Individual participant dataSharing planned: Yes
Related trials for Complication,Postoperative
Recruiting
Endo-SPONGE for Treatment of Anastomotic or Hartmann's Stump Leakages in Lower Pelvic Area
Anastomotic Leaks, Hartmanns Stump Leakage
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Not yet recruiting
Bispectral Index-Guided Propofol Sedation During Endoscopic Retrograde Cholangiopancreatography
Deep Sedation, Endoscopic Retrograde Cholangiopancreatography
Not yet recruitingObservational study
Systematic Intraoperative Cell Salvage in On-Pump Cardiac Surgery Within a Mature Patient Blood Management Programme
Cardiac Surgical Procedures, Blood Transfusion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stanislaw Klek, PhD principal investigator
Stanley Dudrick's Memorial Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immunonutrition, High-protein and Standard ONS in people with Complication,Postoperative, run by Stanley Dudrick's Memorial Hospital at 2 sites in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical complications (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2026.