Preoperative Oral Nutritional Supplement (preOP Booster) in Visceral Surgery

Fresenius Kabi36 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Enrollment

Conditions

Enteral Nutrition (Food for Special Medical Purposes)

Interventions

preOP booster (oral nutritional supplement, food for special medical purposes)DIETARY_SUPPLEMENT

3x1 dosage pre-operatively

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Elective pancreaticoduodenectomy Exclusion Criteria: * Concomitant chemotherapy * Severe malnutrition (SGA score C) * Conditions affecting gastric emptying

Locations (1)

Università Salute-Vita San Raffaele,

Milan, Italy

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

Time frame: up to 30 days after surgery

Data from ClinicalTrials.gov

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