Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0436118158
Study information
Scientific title
Acronym
Study hypothesis
We aim to test the hypothesis that preoperative oral carbohydrate drink has beneficial effects on fatigue and well-being after surgery as well as on insulin resistance, stress response and immune function.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
Surgery
Intervention
A. Carbohydrate drink
B. Placebo
Intervention type
Drug
Phase
Not Specified
Drug names
oral carbohydrate
Primary outcome measure
Outcome measures are to compare the effects of preoperative oral carbohydrate drink versus placebo, primarily on well-being and fatigue in subjects undergoing laparoscopic cholecystectomy.
Secondary outcome measures
Secondary outcomes are to compare the effects on stress response.
Overall trial start date
01/02/2002
Overall trial end date
01/08/2006
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Subjects will be recruited from patients due to undergo a laparoscopic cholecystectomy under the care of two consultant surgeons at Wharfedale General Hospital. The study will be explained to those patients suitable for inclusion.
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/02/2002
Recruitment end date
01/08/2006
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Surgery
Leeds
LS1 3EX
United Kingdom
Sponsor information
Organisation
Department of Health (UK)
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Leeds Teaching Hospitals NHS Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list