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Trial registered on ANZCTR


Registration number
ACTRN12621001576819
Ethics application status
Approved
Date submitted
13/10/2021
Date registered
18/11/2021
Date last updated
18/11/2021
Date data sharing statement initially provided
18/11/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Mentha Piperita in the management of oesophageal soft food bolus impaction
Scientific title
Mentha Piperita in the management of oesophageal soft food bolus impaction: A single centre prospective randomised control trial
Secondary ID [1] 305552 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Soft food bolus obstruction (SFBO) 323943 0
Condition category
Condition code
Oral and Gastrointestinal 321457 321457 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients presenting with food bolus, will have endoscopy performed by a gastroenterologist or gastroenterology trainee under the supervision of a gastroenterologist.
Patient with food bolus distance > 20 cm from incisors will be randomized to receiving either the study drug (2%peppermint oil) or placebo. This will be instilled at an initial volume of 10mls and delivered endoscopically, followed by a further 10mls one minute later if there is no spontaneous resolution of the food bolus. Should there be no spontaneous passage of SFBO one minute after the second administration then a gentle push technique will be trialled. If the push technique fails, then retrieval of the SFBO will be using equipment at the discretion of the endoscopist.
The total duration of the endoscopy is one of the end points that will be measured. Should the peppermint prove successful then the duration of endoscopy in the study arm will be significantly shorter. Difficult food bolus obstruction can sometimes take over 2 hrs to disimpact. Adherence to intervention will be monitored by documentation during procedure.
Intervention code [1] 321949 0
Treatment: Other
Comparator / control treatment
Control group will receive placebo (sterile water), initial volume of 10mls delivered endoscopically, followed by a further 10mls one minute later, if there is no spontaneous resolution of the food bolus.
Should there be no spontaneous passage of SFBO one minute after the second administration then a gentle push technique will be trialled. If the push technique fails, then retrieval of the SFBO will be using equipment at the discretion of the endoscopist
Control group
Placebo

Outcomes
Primary outcome [1] 329235 0
Ability of Mentha Piperita to shorten duration of endoscopic procedure. The total procedure time is recorded on the reporting software. The procedure start and end times are bookmarked by the nurse on this software (i.e "scope in" and scope out" times) during the procedure.
Timepoint [1] 329235 0
At time of endoscopy
Secondary outcome [1] 401858 0
Ability of Mentha Piperita to cause spontaneous passage of food bolus. This will be recorded on a data collection sheet by the endoscopist.
Timepoint [1] 401858 0
At time of endoscopy
Secondary outcome [2] 402652 0
Ability of Mentha Piperita to improve success of push technique for SFBO. This will be recorded on a data collection sheet by the endoscopists. I.e was the food bolus able to be pushed into stomach if it failed to pass spontaneously or did it require extraction using other instruments.
Timepoint [2] 402652 0
At time of endoscopy

Eligibility
Key inclusion criteria
All patients presenting to Logan hospital, 18 years of age with an oesophageal food bolus obstruction will be considered for the study.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who are unable to consent for themselves, those who are pregnant, those with documented stricture, oesophageal mass lesion or Schatzki ring, or those with suspected hard food bolus obstruction or foreign body will be excluded.

Study design
Purpose of the study
Treatment
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)
Blocked randomisation will occur, in blocks of 10 participants.
10 sealed opaque envelopes, five for each study arm.
One envelope is selected for each subject at time of endoscopy.
This will be repeated for each subsequent block.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
As this study is a “proof of concept study” a sample size calculation was not performed. We anticipate recruiting 40 patients to this study, 20 in each arm over a time period of two years.

Descriptive statistics for the cohort will be generated.
Continuous variables will be summarized using means and standard deviations or medians and interquartile ranges, and categorical variables using frequencies and percentages.
Continuous data will be compared between the two arms using t test or Mann-Whitney U test while Categorical data will be compared using Chi-squared test.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
13/12/2021
Actual
Date of last participant enrolment
Anticipated
31/05/2023
Actual
Date of last data collection
Anticipated
31/05/2023
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 20727 0
Logan Hospital - Meadowbrook
Recruitment postcode(s) [1] 35535 0
4131 - Meadowbrook

Funding & Sponsors
Funding source category [1] 309917 0
Hospital
Name [1] 309917 0
Logan Hospital
Country [1] 309917 0
Australia
Primary sponsor type
Hospital
Name
Logan Hospital, Logan Gastroenterology Unit
Address
Logan hospital
Armstrong Rd &, Loganlea Rd, Meadowbrook QLD 4131
Country
Australia
Secondary sponsor category [1] 310948 0
None
Name [1] 310948 0
None
Address [1] 310948 0
Country [1] 310948 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309636 0
Metro South Human Research Ethics Committee
Ethics committee address [1] 309636 0
Ethics committee country [1] 309636 0
Australia
Date submitted for ethics approval [1] 309636 0
13/07/2021
Approval date [1] 309636 0
19/07/2021
Ethics approval number [1] 309636 0
HRECC/2021/QMS/66772

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 114858 0
Dr Jeevithan Sabanathan
Address 114858 0
Logan Hospital
Cnr Loganlea Rd & Armstrong Rd, Meadowbrook, QLD 4131
Country 114858 0
Australia
Phone 114858 0
+61 7 3299 6922
Fax 114858 0
Email 114858 0
Jeevithan.Sabanathan@health.qld.gov.au
Contact person for public queries
Name 114859 0
Jeevithan Sabanathan
Address 114859 0
Logan Hospital
Cnr Loganlea Rd & Armstrong Rd, Meadowbrook, QLD 4131
Country 114859 0
Australia
Phone 114859 0
+61 7 3299 8899
Fax 114859 0
Email 114859 0
Jeevithan.Sabanathan@health.qld.gov.au
Contact person for scientific queries
Name 114860 0
Jeevithan Sabanathan
Address 114860 0
Logan Hospital
Cnr Loganlea Rd & Armstrong Rd, Meadowbrook, QLD 4131
Country 114860 0
Australia
Phone 114860 0
+61 7 3299 8899
Fax 114860 0
Email 114860 0
Jeevithan.Sabanathan@health.qld.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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
No additional documents have been identified.