Study on Safety, Tolerance and Metabolic Effects of a Nutritional Supplement, Given as a Drink Before Gallbladder Surgery
Not Applicable
Completed
- Conditions
- Enteral Nutrition Regimen Prior to Surgery
- Interventions
- Dietary Supplement: PreOP Booster (oral nutritional supplement, food for special medical purposes)
- Registration Number
- NCT00662376
- Lead Sponsor
- Fresenius Kabi
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Test PreOP Booster (oral nutritional supplement, food for special medical purposes) oral nutritional supplement (assignment: according to consecutive random numbers) Control PreOP Booster (oral nutritional supplement, food for special medical purposes) placebo (assignment: according to consecutive random numbers)
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Clinical parameters (infectious and non-infectious complications) until day 7
Trial Locations
- Locations (1)
Queen's Medical Centre, Division of Gastrointestinal Surgery, Nottingham University Hospitals;
🇬🇧Nottingham, United Kingdom