Complication,Postoperative Clinical Trial
— IMM4Official 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.
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 |
Country | Name | City | State |
---|---|---|---|
Poland | Narodowy Instytut Onkologii | Krakow | Malopolska |
Poland | Stanley Dudrick's Memorial Hospital | Skawina | Malopolska |
Lead Sponsor | Collaborator |
---|---|
Stanley Dudrick's Memorial Hospital |
Poland,
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 |
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