Preoperative Oral Nutritional Supplement (preOP Booster) in Visceral Surgery
Not Applicable
Completed
- Conditions
- Enteral Nutrition (Food for Special Medical Purposes)
- Interventions
- Dietary Supplement: preOP booster (oral nutritional supplement, food for special medical purposes)
- Registration Number
- NCT00503334
- Lead Sponsor
- Fresenius Kabi
- Brief Summary
The purpose of this pilot study is to investigate the effect of an oral nutritional supplement (preOP booster) versus placebo regarding metabolic criteria in patients undergoing elective pancreaticoduodenectomy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 36
Inclusion Criteria
- Elective pancreaticoduodenectomy
Exclusion Criteria
- Concomitant chemotherapy
- Severe malnutrition (SGA score C)
- Conditions affecting gastric emptying
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description preOP booster placebo preOP booster (oral nutritional supplement, food for special medical purposes) - preOP booster preOP booster (oral nutritional supplement, food for special medical purposes) -
- Primary Outcome Measures
Name Time Method laboratory measurements: total endogenous antioxidant capacity, free radicals, CRP; up to 30 days after surgery
- Secondary Outcome Measures
Name Time Method postoperative complications, pre- and postoperative discomfort (well-being), muscle strength at 7 days post-op, length of stay (hospital / ICU), ambulation time, gastro intestinal tolerance up to 30 days after surgery
Trial Locations
- Locations (1)
Università Salute-Vita San Raffaele,
🇮🇹Milan, Italy