Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000032358
Ethics application status
Approved
Date submitted
13/10/2016
Date registered
9/01/2017
Date last updated
9/01/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Assessing the influence of chewing gum on the gastric volume in patients fasting for surgery
Scientific title
Assessing the influence of chewing gum on the gastric volume in patients fasting for surgery
Secondary ID [1] 290138 0
Nil Known
Universal Trial Number (UTN)
U1111-1187-5578
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Residual gastric fluid volume 300260 0
Condition category
Condition code
Anaesthesiology 300126 300126 0 0
Anaesthetics
Oral and Gastrointestinal 300127 300127 0 0
Normal oral and gastrointestinal development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention for assessment is pre-operative use of chewing gum outside of the usually applied fasting guidelines limits. Fasting otherwise will be six hours for food and two hours for clear fluids. Participants in the intervention group will be provided with Sugar-free mint flavoured chewing gum (posted out in a participant information pack) and given both verbal and written instructions on how it may be used. Verbal information will be provided by a research assistant, by phone and according to a scripted instruction pro-forma and at the time phone consent for participation is obtained. Written information will be included in the mailed participant pack. Instructions to participants will include to start chewing sugar-free chewing gum from the time of fasting from food. A packet of commonly used mint flavoured sugar-free gum will be sent out in the post with the study paperwork. Participants will be instructed to keep chewing gum right up until the nurses at Calvary Endoscopy to tell them to stop (when the nurses start preparing them for gastroscopy). Participants will be asked to take note of what time they start chewing the gum and how many pieces of gum are used out of the packet.
Intervention code [1] 295893 0
Prevention
Comparator / control treatment
The control group will be asked to adhere to the usually applied fasting guidelines limits (six hours for food and two hours for clear fluids). Participants in the control group will be specifically instructed not to consume chewing gum.
Control group
Active

Outcomes
Primary outcome [1] 299613 0
The primary outcome measure will be the proportion of cases with stomach aspiration volumes greater than 50ml, reflecting a clinically relevant threshold for risk of aspiration if such volumes were regurgitated during anaesthesia.
Timepoint [1] 299613 0
Time of elective gastroscopy procedure
Secondary outcome [1] 327686 0
Distribution of gastric content volumes: Both groups of patients will undergo their gastroscopy under a general anaesthetic. After insertion of the gastroscope the stomach will be inspected and then drained of any fluid by sucking it out through the suction channel of the gastroscope under direct vision by the gastroenterologist. The volume of the fluid sucked is then measured and recorded for each patient.
Timepoint [1] 327686 0
Time of elective gastroscopy procedure
Secondary outcome [2] 327687 0
Distribution of gastric content pH. The pH of the fluid sucked will be measured and recorded for each patient using a electronic fluid pH meter (testo 206 pH1 - pH meter for liquids, Testo Aus)
Timepoint [2] 327687 0
Time of elective gastroscopy procedure

Eligibility
Key inclusion criteria
Adult patients aged greater than 18 years, who after being booked for an elective gastroscopy by their treating gastroenterologist at the specialist’s rooms, will be asked to take part in the trial.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
i. Age less than 18 years
ii. Patient declines to be recruited as a participant in the trial
iii. Patient has a past history of upper gastrointestinal surgery including but not limited to : total or partial gastrectomy, operations involving gastroenterostomy (eg Whipples procedure), gastric lap band, laparoscopic sleeve gastrectomy, Nissen fundoplication, gastric pyeloplasty
iv. Past history of achalasia, severe oesophageal stricture, oesophageal carcinoma or other swallowing disorder
v. Past history of scleroderma or other disease causing gastroparesis
vi. Chronic oral opioid use or other medication causing delayed gastric emptying
vii. Patient deemed not competent to consent to the trial or competent to follow instructions required by the trial

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelope
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety
Statistical methods / analysis
The primary outcome measure (proportion of cases with stomach aspiration volumes greater than 50ml) would be estimated and compared using Poisson regression. Unadjusted and adjusted estimates would be made, with adjustment for potentially confounding variables: those variables would be selected from the measured demographic variables using backward stepwise regression.
Secondary outcome measures (distribution of gastric content volumes and pH) are expected to be strongly skewed distributions, so the two groups will be compared using ordered logistic regression (a rank-ordered test of distribution that allows adjustment for potentially confounding covariates). The distributions will be described as proportions of patients above a series of thresholds of increasing clinical risk (50ml, 75ml, 100ml etc) & (pH 4.0, 3.0, 2.5, 2.0 etc)

The sample size of 102 completed patients per group would be sufficient to detect a minimum absolute difference in the proportion of patients with a clinically relevant aspirated stomach volume of over 50ml of 10%, assuming that the proportion over 50ml in the control group is 2% with power 80% and P-value 0.05.


Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/02/2017
Actual
Date of last participant enrolment
Anticipated
1/07/2017
Actual
Date of last data collection
Anticipated
1/07/2018
Actual
Sample size
Target
204
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
TAS
Recruitment hospital [1] 6659 0
Calvary Health Care Tasmania - Launceston campus - Launceston
Recruitment postcode(s) [1] 14284 0
7250 - Launceston

Funding & Sponsors
Funding source category [1] 294513 0
Charities/Societies/Foundations
Name [1] 294513 0
Clifford Craig Medical Research Trust
Country [1] 294513 0
Australia
Primary sponsor type
Individual
Name
Gregg Best
Address
Principal investigator,
Country
Australia
Secondary sponsor category [1] 293379 0
None
Name [1] 293379 0
Address [1] 293379 0
Country [1] 293379 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295950 0
Tasmanian Health and Medical Human Research Ethics Committee
Ethics committee address [1] 295950 0
Ethics committee country [1] 295950 0
Australia
Date submitted for ethics approval [1] 295950 0
20/10/2016
Approval date [1] 295950 0
16/12/2016
Ethics approval number [1] 295950 0
H0016137

Summary
Brief summary
The need for a period of fasting (not eating or drinking) before having a general anaesthetic is well known and accepted by the community. This measure is necessary to prevent patients from regurgitating and inhaling stomach contents, a phenomenon known as pulmonary aspiration. Many people find fasting an unpleasant experience with hunger, thirst and dry mouth common complaints. Some individuals find chewing gum while fasting helps with these symptoms, however, currently there is no significant medical evidence to either support or refute the safety of chewing gum in this period.

Our group proposes to conduct a study in patients who are booked by their gastroenterologist for a gastroscopy (an inspection of the inside of their stomach with a telescope). We intend to randomly divide people into two groups, the first group will fast before their procedure as per the current normal instructions. The second group will also fast, but will be asked to chew gum during their period of fasting before the endoscopy. Both groups of patients will undergo their gastroscopy under a general anaesthetic. After insertion of the telescope the stomach will be inspected and then drained of any fluid by sucking it out through the suction channel of the telescope under direct vision by the gastroenterologist. It is normal for all people to a have a small volume (usually 20-30ml) of fluid in their stomach despite not eating or drinking due to swallowing saliva and the stomach producing its own secretions. The volume of the fluid sucked is then measured and recorded for each patient. The data collected during the course of the study will be collated and analysed statistically looking for any differences between the two study groups. Once completed, the results of the study will be published in the medical literature.

The investigators postulate that chewing gum will make no significant difference in the amount of fluid in the stomach of a patient fasting before an operation. In fact, the action of chewing gum may actually be beneficial in stimulating the stomach to empty its normal residual volume of fluid. The information gained from this study will be valuable to all anaesthetists in streamlining pre-operative fasting guidelines for their patients to ensure safety as well as potentially improving comfort while they are fasting.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 69014 0
Dr Gregg Best
Address 69014 0
Department of Anaesthesia, Launceston General Hospital
Charles St, Launceston
Tas 7250
Country 69014 0
Australia
Phone 69014 0
+61 3 67776576
Fax 69014 0
Email 69014 0
[email protected]
Contact person for public queries
Name 69015 0
Dr Gregg Best
Address 69015 0
Department of Anaesthesia, Launceston General Hospital
Charles St, Launceston
Tas 7250
Country 69015 0
Australia
Phone 69015 0
+61 3 67776576
Fax 69015 0
Email 69015 0
[email protected]
Contact person for scientific queries
Name 69016 0
Dr Gregg Best
Address 69016 0
Department of Anaesthesia, Launceston General Hospital
Charles St, Launceston
Tas 7250
Country 69016 0
Australia
Phone 69016 0
+61 3 67776576
Fax 69016 0
Email 69016 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseAssessing the effect of sugar-free chewing gum use on the residual gastric volume of patients fasting for gastroscopy: A randomised controlled trial.2019https://dx.doi.org/10.1177/0310057X19886881
N.B. These documents automatically identified may not have been verified by the study sponsor.