NCT00503334CompletedNot Applicable
Efficacy and Tolerability of a Preoperative Oral Nutritional Supplement (preOP Booster) Versus Placebo in Visceral Surgery
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Fresenius Kabi
- Enrollment
- 36
- Locations
- 1
- Primary Endpoint
- laboratory measurements: total endogenous antioxidant capacity, free radicals, CRP;
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Elective pancreaticoduodenectomy
Exclusion Criteria
- •Concomitant chemotherapy
- •Severe malnutrition (SGA score C)
- •Conditions affecting gastric emptying
Arms & Interventions
preOP booster
Experimental
Intervention: preOP booster (oral nutritional supplement, food for special medical purposes) (Dietary Supplement)
preOP booster placebo
Placebo Comparator
Intervention: preOP booster (oral nutritional supplement, food for special medical purposes) (Dietary Supplement)
Outcomes
Primary Outcomes
laboratory measurements: total endogenous antioxidant capacity, free radicals, CRP;
Time Frame: up to 30 days after surgery
Secondary Outcomes
- 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)
Investigators
Study Sites (1)
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