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

December 5, 2008 updated by: Fresenius Kabi

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Test
oral nutritional supplement (assignment: according to consecutive random numbers)
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
Placebo Comparator: Control
placebo (assignment: according to consecutive random numbers)
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety parameters reflecting pathophysiological functions of the liver
Time Frame: day -1, 0, 1, and 7
day -1, 0, 1, and 7
Gastrointestinal tolerance
Time Frame: day 0 before and 6-8h after surgery
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
on day -1, 0, 1, and 7

Secondary Outcome Measures

Outcome Measure
Time Frame
Clinical parameters (infectious and non-infectious complications)
Time Frame: until day 7
until day 7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fresenius Kabi

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (Actual)

October 1, 2008

Study Completion (Actual)

October 1, 2008

Study Registration Dates

First Submitted

April 17, 2008

First Submitted That Met QC Criteria

April 18, 2008

First Posted (Estimate)

April 21, 2008

Study Record Updates

Last Update Posted (Estimate)

December 8, 2008

Last Update Submitted That Met QC Criteria

December 5, 2008

Last Verified

November 1, 2008

More Information

Terms related to this study

Other Study ID Numbers

  • N-POB-01-UK

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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