|
ISRCTN
|
ISRCTN98555764
|
|
ClinicalTrials.gov identifier
|
|
|
Public title
|
Determination of safety of patients drinking before gastroscopy
|
|
Scientific title
|
|
|
Acronym
|
GaFFA
|
|
Serial number at source
|
N0500103996 and N0300106567
|
|
Study hypothesis
|
To determine the clinical equivalence of a shortened and conventional fluid fasting time in endoscopy patients in levels of gastric volume and pH.
|
|
Lay summary
|
|
|
Ethics approval
|
Approved by the Blackburn Hyndburn and Ribble Valley National Health Service Trust Local Research Ethics Committee, November 2001 (reference number: NJ/AK/LRECBHRV061).
|
|
Study design
|
Double-blind randomised controlled clinical equivalence trial
|
|
Countries of recruitment
|
United Kingdom
|
|
Disease/condition/study domain
|
Digestive system disease requiring diagnostic endoscopy
|
|
Participants - 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
|
|
Participants - exclusion criteria
|
1. ASA grade three or greater
2. Previous gastric or duodenal surgery
3. Dysphagia
4. Patients taking acid suppressing medications
5. Diabetes
|
|
Anticipated start date
|
18/06/2002
|
|
Anticipated end date
|
31/03/2006
|
|
Status of trial
|
Completed |
|
Patient information material
|
|
|
Target number of participants
|
508
|
|
Interventions
|
1. Study group: six-hour food fast, two-hour water fast
2. Control group: standard six-hour food and fluid fast
|
|
Primary outcome measure(s)
|
1. Gastric volume
2. pH
|
|
Secondary outcome measure(s)
|
1. Thirst
2. Anxiety
|
|
Sources of funding
|
National Health Service Executive (UK) (ref: RDO/28/3/21)
|
|
Trial website
|
|
|
Publications
|
|
|
Contact name
|
Ms
Lesley
Miller
|
|
Address
|
Department of Gastroenterology
Blackburn Royal Infirmary
Bolton Road
Blackburn
|
|
City/town
|
Lancashire
|
|
Zip/Postcode
|
BB2 3LR
|
|
Country
|
United Kingdom
|
|
Tel
|
+44 (0)1254 294222
|
|
Email
|
|
|
Sponsor
|
National Health Service Executive (UK)
|
|
Address
|
Institute for Public Health Research and Policy
University of Salford
4th Floor
Humphrey Booth House
Hulme Place
The Crescent
|
|
City/town
|
Salford
|
|
Zip/Postcode
|
M5 4QA
|
|
Country
|
United Kingdom
|
|
Date applied
|
11/12/2005
|
|
Last edited
|
25/01/2010
|
|
Date ISRCTN assigned
|
29/03/2006
|
