Enteral Nutrition Regimen Prior to Surgery
Conditions
Brief summary
The aim of this pilot study is to obtain data on the safety, tolerance and metabolic effects of the oral nutritional supplement (PreOP Booster) given to patients prior to gastrointestinal surgery.
Interventions
3 x 1 dosages of oral nutritional supplement / placebo are given prior to surgery: 2 the evening before the day of operation and 1 dosage 3-4 h before initiation of anaesthesia
Sponsors
Fresenius Kabi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* elective laparoscopic cholecystectomy
Exclusion criteria
* bile duct stones * ileus * conditions affecting gastric emptying * severe, organ-specific disorders * HIV * inherited metabolic disorders * known intolerance against or allergy to any component of the investigational feeds
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety parameters reflecting pathophysiological functions of the liver | day -1, 0, 1, and 7 |
| Gastrointestinal tolerance | day 0 before and 6-8h after surgery |
| Metabolic parameters in serum, liver and muscle tissue | on day -1, 0, 1, and 7 |
Secondary
| Measure | Time frame |
|---|---|
| Clinical parameters (infectious and non-infectious complications) | until day 7 |
Countries
United Kingdom
Outcome results
None listed