Determination of safety of patients drinking before gastroscopy
| ISRCTN | ISRCTN98555764 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN98555764 |
| Secondary identifying numbers | N0500103996 and N0300106567 |
- 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
| Study design | Double-blind randomised controlled clinical equivalence trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| 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 | 1. Gastric volume 2. pH |
| Secondary outcome measures | 1. Thirst 2. Anxiety |
| Overall study start date | 18/06/2002 |
| Completion date | 31/03/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 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
- England
- United Kingdom
Study participating centre
Department of Gastroenterology
Lancashire
BB2 3LR
United Kingdom
BB2 3LR
United Kingdom
Sponsor information
National Health Service Executive (UK)
Government
Government
Institute for Public Health Research and Policy
University of Salford
4th Floor
Humphrey Booth House
Hulme Place
The Crescent
Salford
M5 4QA
United Kingdom
"ROR" |
https://ror.org/02wnqcb97 |
|---|
Funders
Funder type
Government
National Health Service Executive (UK) (ref: RDO/28/3/21)
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 |
