Plain English Summary
Background and study aims
Preoperative fasting is routinely applied before any procedure with general anaesthesia, with the goal of avoiding the risk of aspiration of gastric contents into the trachea (breathing tube). However, the safe limits for ingestion are not well defined. Studies in children suggest that a limited quantity of semisolid food, e.g. milk products, may be eliminated from the stomach well within a fasting period of 4 hours, which is shorter than the currently prescribed 6 hours. The primary aim of this study is to investigate if a set amount of milk-based drink is eliminated from the stomach within 4 hours of ingestion. The secondary aims are to investigate if there is a difference in gastric content after drinking low- or high-fat yoghurt, and to validate ultrasound for determining the gastric content volume after 4 hours of fasting.
Who can participate?
Adult patients who have been referred to the Endoscopy Unit at Uppsala University Hospital for endoscopic examination of the stomach (gastroscopy)
What does the study involve?
In the first phase of the study, 100 adults scheduled for a gastroscopy (investigation of the stomach with a fibreoptic camera) are instructed to drink one glass (250 ml) or two glasses (500 ml) of milk 4 hours before the planned procedure. During the gastroscopy, any gastric content is suctioned into a container and analysed with respect to volume and type of content (clear, milk-stained or solid content). The procedure then continues according to the clinical routine. In the second phase of the study, a different set of 100 adults scheduled for gastroscopy are instructed to drink a fixed volume of either low-fat (50 kcal/100 ml) or high-fat yoghurt (100 kcal/100 ml). The volume will be either 250 ml or 500 ml, depending on the results of the first phase of the study. The gastroscopy is carried out as for the first group above. In addition, an ultrasound examination of the stomach is performed to determine the type and estimate the volume of any residual content. This ultrasound examination is performed immediately before the gastroscopy.
What are the possible benefits and risks of participating?
Participating in the study does not give any possible benefits. There are no known risks of participating. The gastroscopy is performed as per routine, with the exception that the initial contents of the stomach are suctioned out at the beginning of the procedure instead of at the end. The ultrasound examination is non-invasive and painless, and poses no risks to the participant.
Where is the study run from?
Uppsala University Hospital (Sweden)
When is the study starting and how long is it expected to run for?
The planning of the study started in May 2018. The first inclusion of participants is planned for January 20th, 2020. The study is expected to run for approximately 12 months.
Who is funding the study?
Uppsala University Hospital (Sweden)
Who is the main contact?
Dr Peter Frykholm
peter.frykholm@surgsci.uu.se
Trial website
Contact information
Type
Public
Primary contact
Dr Peter Frykholm
ORCID ID
http://orcid.org/0000-0001-6402-136X
Contact details
Dep. of Surgical Sciences
Section of Anaesthesiology and intensive care medicine
Uppsala
75185
Sweden
+46 (0)18 6171240
peter.frykholm@surgsci.uu.se
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
1
Study information
Scientific title
Is gastric emptying complete 4 hours after intake of 250 or 500 ml milk or yoghurt?
Acronym
GMILK
Study hypothesis
Gastric emptying of 250 ml milk or yoghurt is complete within 4 hours of intake.
Ethics approval
Approved 18/08/2018, Uppsala Regional Ethics Committee (Box 1964, 751 49 Uppsala, Sweden; correspondence should be sent to the new Swedish Ethics Review Authority, Box 2120, 750 02 Uppsala, Sweden), ref: 2018/286
Study design
Prospective observational cohort study
Primary study design
Observational
Secondary study design
Cohort study
Trial setting
Hospitals
Trial type
Diagnostic
Patient information sheet
Available on request from the principal investigator. Available only in Swedish.
Condition
Adult patients referred for gastroscopy due to gastrointestinal complaints or other symptoms
Intervention
In the first phase of the study, 100 adults scheduled for gastroscopy are instructed to drink one glass (250 ml) or two glasses (500 ml) of milk 4 hours before the planned procedure. During the gastroscopy, any gastric content is suctioned into a container and analysed with respect to volume and type of content (clear, milk-stained or solid content). This is the endpoint of the study, and the procedure then continues according to the clinical routine.
In the second phase of the study, a different set of 100 adults scheduled for gastroscopy are instructed to drink a fixed volume of either low-fat (50 kcal/100ml) or high-fat yoghurt (100 kcal/100ml). The volume will be either 250 ml or 500 ml, depending on the results of the first phase of the study. The gastroscopy part of the protocol is as for the first group above. In addition, an ultrasound examination of the stomach is performed to determine the type and estimate the volume of any residual content. This ultrasound examination is performed immediately before the gastroscopy.
Intervention type
Other
Phase
Drug names
Primary outcome measure
The volume of milk-stained or solid gastric content in ml, 4 hours after ingestion of milk or yoghurt, that can be suctioned from the stomach, measured as soon as the endoscope enters the stomach
Secondary outcome measures
1. The volume of gastric content in ml, estimated with ultrasound, 4 hours after ingestion of milk or yoghurt and immediately before gastroscopy, compared with the volume suctioned through the endoscope the first time it enters the stomach
2. The volume of gastric content in ml, 4 hours after ingestion of low-fat or high-fat yoghurt, measured as soon as the endoscope enters the stomach
Overall trial start date
01/05/2018
Overall trial end date
01/05/2021
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Adult patients referred for gastroscopy because of gastrointestinal symptoms
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
200
Participant exclusion criteria
1. Age < 18 years
2. Age > 60 years
3. Body mass index > 30
4. Condition known to be associated with delayed gastric emptying
Recruitment start date
20/01/2020
Recruitment end date
20/01/2021
Locations
Countries of recruitment
Sweden, Switzerland
Trial participating centre
Endoscopy unit, Uppsala University Hospital
Sjukhusvägen 1
Uppsala
75185
Sweden
Sponsor information
Organisation
Uppsala University Hospital
Sponsor details
Sjukhusvägen 1
Uppsala
75185
Sweden
+46 (0)18 6110000
peter.frykholm@akademiska.se
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
University/education
Funder name
Uppsala Universitet
Alternative name(s)
Uppsala University
Funding Body Type
private sector organisation
Funding Body Subtype
Universities (academic only)
Location
Sweden
Results and Publications
Publication and dissemination plan
The results will be presented at scientific meetings and published in a peer-reviewed scientific journal in 2021
IPD sharing statement
The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Peter Frykholm (peter.frykholm@surgsci.uu.se). The patients have consented to sharing anonymised data on a group level. Researchers or peer reviewers may also obtain anonymised raw data. The data will be saved up to 10 years after publication.
Intention to publish date
01/06/2021
Participant level data
Available on request
Basic results (scientific)
Publication list
Publication citations
Additional files
- ISRCTN17698655_PROTOCOL.pdf uploaded 05/02/2020