Study on Safety, Tolerance and Metabolic Effects of a Nutritional Supplement, Given as a Drink Before Gallbladder Surgery

Fresenius Kabi40 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Enrollment

Conditions

Enteral Nutrition Regimen Prior to Surgery

Interventions

PreOP Booster (oral nutritional supplement, food for special medical purposes)DIETARY_SUPPLEMENT

3 x 1 dosages of oral nutritional supplement / placebo are given prior to surgery: 2 the evening before the day of operation and 1 dosage 3-4 h before initiation of anaesthesia

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Queen's Medical Centre, Division of Gastrointestinal Surgery, Nottingham University Hospitals;

Nottingham, United Kingdom

Outcomes

Primary Outcomes

Safety parameters reflecting pathophysiological functions of the liver

Time frame: day -1, 0, 1, and 7

Gastrointestinal tolerance

Time frame: day 0 before and 6-8h after surgery

Metabolic parameters in serum, liver and muscle tissue

Time frame: on day -1, 0, 1, and 7

Secondary Outcomes

Clinical parameters (infectious and non-infectious complications)

Time frame: until day 7

Data from ClinicalTrials.gov

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