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Preoperative Oral Nutritional Supplement (preOP Booster) in Visceral Surgery

Not Applicable
Completed
Conditions
Enteral Nutrition (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
Primary Outcome Measures
NameTimeMethod
laboratory measurements: total endogenous antioxidant capacity, free radicals, CRP;up to 30 days after surgery
Secondary Outcome Measures
NameTimeMethod
postoperative complications, pre- and postoperative discomfort (well-being), muscle strength at 7 days post-op, length of stay (hospital / ICU), ambulation time, gastro intestinal toleranceup to 30 days after surgery

Trial Locations

Locations (1)

Università Salute-Vita San Raffaele,

🇮🇹

Milan, Italy

Università Salute-Vita San Raffaele,
🇮🇹Milan, Italy

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