Condition category
Digestive System
Date applied
11/12/2005
Date assigned
29/03/2006
Last edited
15/02/2013
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

Ms Lesley Miller

ORCID ID

Contact details

Department of Gastroenterology
Blackburn Royal Infirmary
Bolton Road
Blackburn
Lancashire
BB2 3LR
United Kingdom
+44 (0)1254 294222

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0500103996 and N0300106567

Study information

Scientific title

Acronym

GaFFA

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.

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

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

1. Gastric volume
2. pH

Secondary outcome measures

1. Thirst
2. Anxiety

Overall trial start date

18/06/2002

Overall trial end date

31/03/2006

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

508

Participant exclusion criteria

1. ASA grade three or greater
2. Previous gastric or duodenal surgery
3. Dysphagia
4. Patients taking acid suppressing medications
5. Diabetes

Recruitment start date

18/06/2002

Recruitment end date

31/03/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Gastroenterology
Lancashire
BB2 3LR
United Kingdom

Sponsor information

Organisation

National Health Service Executive (UK)

Sponsor details

Institute for Public Health Research and Policy
University of Salford
4th Floor
Humphrey Booth House
Hulme Place
The Crescent
Salford
M5 4QA
United Kingdom

Sponsor type

Government

Website

Funders

Funder type

Government

Funder name

National Health Service Executive (UK) (ref: RDO/28/3/21)

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