Preoperative oral carbohydrate drink versus placebo: a pilot study of the role of preoperative oral carbohydrate loading in the outcome of short stay and day surgery
| ISRCTN | ISRCTN65541943 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN65541943 |
| Secondary identifying numbers | N0436118158 |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 14/03/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Miss KM Maude
Scientific
Scientific
Department of Surgery
LIMIT Suite, 6th Floor
Wellcome Wing
Leeds General Infirmary
Leeds
LS1 3EX
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Scientific title | |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Surgery |
| Intervention | A. Carbohydrate drink B. Placebo |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | 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 study start date | 01/02/2002 |
| Completion date | 01/08/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | Not provided at time of registration |
| Key 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. |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/02/2002 |
| Date of final enrolment | 01/08/2006 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Department of Surgery
Leeds
LS1 3EX
United Kingdom
LS1 3EX
United Kingdom
Sponsor information
Department of Health (UK)
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.doh.gov.uk |
|---|
Funders
Funder type
Government
Leeds Teaching Hospitals NHS Trust (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
