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OpenTrials
Completed

NCT Number: NCT00662376

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

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.

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Key information

Conditions

Enteral Nutrition Regimen Prior to Surgery

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Nottingham, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Safety parameters reflecting pathophysiological functions of the liver

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

  2. Gastrointestinal tolerance

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

  3. Metabolic parameters in serum, liver and muscle tissue

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

Secondary outcomes

  1. Clinical parameters (infectious and non-infectious complications)

    Time frame: until day 7

Sponsors and collaborators

Lead sponsor

Fresenius Kabi

Industry

Registry information

Official study title

Safety, Tolerance and Metabolic Effects of Using a Preoperative Oral Nutritional Supplement (PreOP Booster) in Gastrointestinal Surgery

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Apr 21, 2008
Registry last updated
Dec 8, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.