Condition category
Surgery
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
14/03/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Miss KM Maude

ORCID ID

Contact details

Department of Surgery
LIMIT Suite
6th Floor
Wellcome Wing
Leeds General Infirmary
Leeds
LS1 3EX
United Kingdom

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 measures

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

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

http://www.doh.gov.uk

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes