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
-
-
-
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)
|
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)
|
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
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
- Awad S, Stephens F, Shannon C, Lobo DN. Perioperative perturbations in carnitine metabolism are attenuated by preoperative carbohydrate treatment: Another mechanism by which preoperative feeding may attenuate development of postoperative insulin resistance. Clin Nutr. 2012 Oct;31(5):717-20. doi: 10.1016/j.clnu.2012.02.015. Epub 2012 Mar 22.
- Awad S, Constantin-Teodosiu D, Constantin D, Rowlands BJ, Fearon KC, Macdonald IA, Lobo DN. Cellular mechanisms underlying the protective effects of preoperative feeding: a randomized study investigating muscle and liver glycogen content, mitochondrial function, gene and protein expression. Ann Surg. 2010 Aug;252(2):247-53. doi: 10.1097/SLA.0b013e3181e8fbe6.
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.