General Surgery, Cancer of Colon
Conditions
Keywords
immunonutrition, preoperative nutrition
Brief summary
Immunomodulating nutrition is supposed to reduce the number of complications and the legnth of the hospital stay during the postoperative period in patients after major gastrointestinal surgery. The aim of the study is to assess the clinical effect of immunomodulating oral nutrition in patients undergoing resection for gastrointestinal cancer in the group of well-nourished patients.
Detailed description
Between March 1, 2019, and December 31, 2020, a group of 300 well-nourished patients will be enrolled to the study and randomly assigned two one of two groups: A-high protein oral supplements (ONS) and B- immunomodulating ONS. The study is designed to test the hypothesis that immunonutrition and reduce the incidence of infectious complications after upper gastrointestinal surgery; the secondary objective of the study was to evaluate the effect of nutritional intervention on overall morbidity and mortality rates, and hospital stay.
Interventions
DRUGIMPACT
Administration of oral immunostimulating oral supplement
DRUGresource protein
Administration of oral high-protein oral supplement
Sponsors
Stanley Dudrick's Memorial Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* resectable GI cancer * written consent
Exclusion criteria
* inoperable GI cancer * known allergy to the drug
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Infectious complications | 6 months | Number and type of infectious complications |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Surgical complications | 6 months | Number and type of surgical complications |
| Length of stay | 14 days | Hospital length of stay |
Countries
Poland
Outcome results
None listed