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

NCT00662376 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2008-12-08

No results posted yet for this study

Summary

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.

Conditions

  • Enteral Nutrition Regimen Prior to Surgery

Interventions

DIETARY_SUPPLEMENT

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

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

Sponsors & Collaborators

  • Fresenius Kabi

    lead INDUSTRY

Principal Investigators

  • Dileep N. Lobo, MS, DM, FRCS · Queen's Medical Centre, Division of Gastrointestinal Surgery, Nottingham University Hospitals;

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-04-30
Primary Completion
2008-10-31
Completion
2008-10-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00662376 on ClinicalTrials.gov