Impact of Various Diets on Surgical Complications

Complication,Postoperative Clinical Trial

— IMM4  

Official title:

Impact of Immunomodulating Oral Nutrition on Surgical Complications

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05069402
• Other study ID #: 4armsimmuno
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2021
• Est. completion date: March 31, 2023

Study information

• Verified date: October 2021
• Source: Stanley Dudrick's Memorial Hospital
• Contact: Stanislaw Klek, PhD
• Phone: +48604293566
• Email: klek[@]poczta.onet.pl
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: March 31, 2023
• Est. primary completion date: January 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Complication,Postoperative
• Postoperative Complications

Intervention

Dietary Supplement:
• Immunonutrition
diet with immunonutrients
• High-protein
Oral nutrition with high-protein content
• Standard ONS
Oral nutrition with standard ingredients

Locations

Country	Name	City	State
Poland	Narodowy Instytut Onkologii	Krakow	Malopolska
Poland	Stanley Dudrick's Memorial Hospital	Skawina	Malopolska

Sponsors (1)

Lead Sponsor	Collaborator
Stanley Dudrick's Memorial Hospital

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Surgical complications	Number and type of surgical complications	6 months
Primary	Infectious complications	Number and type of infectious complications	6 months
Secondary	Length of stay	Days of hospital stay after the operation	6 months