Impact of Various Diets on Surgical Complications (IMM4)

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.

Study Overview

• Status: Recruiting
• Conditions: Complication,Postoperative
• Intervention / Treatment: Dietary supplement: Immunonutrition; Dietary supplement: High-protein; Dietary supplement: Standard ONS

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 Type: Interventional
• Enrollment (Anticipated): 300
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Poland
  • Malopolska
    • Krakow, Malopolska, Poland, 31-115
      • Recruiting
      • Narodowy Instytut Onkologii
      • Contact: Stanislaw Klek, PhD; Phone Number: 60293566; Email: stanislaw.klek@onkologia.krakow.pl
    • Skawina, Malopolska, Poland, 32-050
      • Recruiting
      • Stanley Dudrick's Memorial Hospital
      • Contact: Stanley Dudrick's M Hospital; Phone Number: 604293566; Email: klek@poczta.onet.pl
      • Contact: Email: klek@poczta.onet.pl
      • Principal Investigator: Stanislaw Klek

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Immunonutrition; Oral immunonutrition containing arginine, omega-PUFAs and antioxidants	Dietary supplement: Immunonutrition; diet with immunonutrients
ACTIVE_COMPARATOR: High-protein diet; Oral nutrition with high-protein content	Dietary supplement: High-protein; Oral nutrition with high-protein content
ACTIVE_COMPARATOR: Standard nutrition; Oral nutrition with standard components	Dietary supplement: Standard ONS; Oral nutrition with standard ingredients

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Infectious complications	Number and type of infectious complications	6 months
Surgical complications	Number and type of surgical complications	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of stay	Days of hospital stay after the operation	6 months

Collaborators and Investigators

• Sponsor: Stanley Dudrick's Memorial Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 1, 2021
• Primary Completion (ANTICIPATED): January 31, 2023
• Study Completion (ANTICIPATED): March 31, 2023

Study Registration Dates

• First Submitted: September 25, 2021
• First Submitted That Met QC Criteria: September 25, 2021
• First Posted (ACTUAL): October 6, 2021

Study Record Updates

• Last Update Posted (ACTUAL): October 14, 2021
• Last Update Submitted That Met QC Criteria: October 6, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications
• Other Study ID Numbers: 4armsimmuno

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Time Frame: 12 months
• IPD Sharing Access Criteria: any health professional
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No