Determination of safety of patients drinking before gastroscopy
| ISRCTN | ISRCTN98555764 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN98555764 |
| Protocol serial number | N0500103996 and N0300106567 |
| Sponsor | National Health Service Executive (UK) |
| Funder | National Health Service Executive (UK) (ref: RDO/28/3/21) |
- Submission date
- 11/12/2005
- Registration date
- 29/03/2006
- Last edited
- 15/02/2013
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
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
Ms Lesley Miller
Scientific
Scientific
Department of Gastroenterology
Blackburn Royal Infirmary
Bolton Road
Blackburn
Lancashire
BB2 3LR
United Kingdom
| Phone | +44 (0)1254 294222 |
|---|
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Double-blind randomised controlled clinical equivalence trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study acronym | GaFFA |
| Study objectives | To determine the clinical equivalence of a shortened and conventional fluid fasting time in endoscopy patients in levels of gastric volume and pH. |
| Ethics approval(s) | Approved by the Blackburn Hyndburn and Ribble Valley National Health Service Trust Local Research Ethics Committee, November 2001 (reference number: NJ/AK/LRECBHRV061). |
| Health condition(s) or problem(s) studied | Digestive system disease requiring diagnostic endoscopy |
| Intervention | 1. Study group: six-hour food fast, two-hour water fast 2. Control group: standard six-hour food and fluid fast |
| Intervention type | Other |
| Primary outcome measure(s) |
1. Gastric volume |
| Key secondary outcome measure(s) |
1. Thirst |
| Completion date | 31/03/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 508 |
| Key inclusion criteria | 1. Aged 18 to 80 years 2. Undergoing routine diagnostic out-patient endoscopy 3. American Society of Anesthesiologists (ASA) grade one to two |
| Key exclusion criteria | 1. ASA grade three or greater 2. Previous gastric or duodenal surgery 3. Dysphagia 4. Patients taking acid suppressing medications 5. Diabetes |
| Date of first enrolment | 18/06/2002 |
| Date of final enrolment | 31/03/2006 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Department of Gastroenterology
Lancashire
BB2 3LR
United Kingdom
BB2 3LR
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
