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Trial registered on ANZCTR
Registration number
ACTRN12625000017426p
Ethics application status
Not yet submitted
Date submitted
11/12/2024
Date registered
10/01/2025
Date last updated
10/01/2025
Date data sharing statement initially provided
10/01/2025
Type of registration
Prospectively registered
Titles & IDs
Public title
Effect of water soluble defoamer on colonoscopic bubble score in adult patients undergoing colonoscopy
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Scientific title
Effect of water soluble defoamer on colonoscopic bubble score in adult patients undergoingr colonoscopy
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Secondary ID [1]
313553
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Nil
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
colonoscopy
336043
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Condition category
Condition code
Surgery
332668
332668
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0
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Other surgery
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Oral and Gastrointestinal
332608
332608
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0
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
This is a prospective, open-labelled pilot study of adult patients undergoing colonoscopy at University Hospital Geelong.
Patients will be recruited for the study at the time of booking for their colonoscopy, and informed consent will be obtained by the doctor arranging the colonoscopy. All patients will have been booked for the procedure on clinical grounds, they will NOT undergo the procedure purely for the purposes of the study. Patients will undergo pre- operative bowel preparation, anaesthesia, and colonoscopy according to the standard current protocols.
If the endoscopists view is obscured by bubbles, propylene glycol solution will be instilled via the working channel of the colonoscope. This will be instilled at a concentration of 0.1g/ml in 10ml flushes until adequate views are obtained, or up to a maximum of 60ml. This would give a maximum dose of 6g, which is approximately the amount that could be added to one orange under Australian food safety regulations. The number of flushes delivered to obtain clear views will be recorded.
The extent of bubbles will be recorded using a previously published [Mallard et al 2023] endoscopic bubble scale (Grade 0 [minimal or no bubbles]; 1 [bubbles covering <50% of the luminal circumference]; 2 [bubbles covering >50% the lumen circumference]; 3 [bubbles filling the entire lumen]) before flushing and within 30 seconds after flushing.
If adequate views cannot be obtained after flushing with 60ml propylene glycol, further flushing will be done as needed using cimethicone at the endoscopists discretion in keeping with standard clinical practice.
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Intervention code [1]
330144
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Early detection / Screening
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Comparator / control treatment
Nil
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
340123
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Colonoscopic bubble score
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Assessment method [1]
340123
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Assessment by endoscopist- subjective bubble score
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Timepoint [1]
340123
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Immediate
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Secondary outcome [1]
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Nil
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Assessment method [1]
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Nil
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Timepoint [1]
442848
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Nil
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Eligibility
Key inclusion criteria
Adult patients undergoing colonoscopy at University Hospital Geelong.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Under age 18.
Unable to understand consent.
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Study design
Purpose of the study
Diagnosis
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
15/02/2025
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Actual
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Date of last participant enrolment
Anticipated
30/07/2025
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Actual
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Date of last data collection
Anticipated
30/07/2025
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Actual
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Sample size
Target
200
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Funding & Sponsors
Funding source category [1]
318015
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University
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Name [1]
318015
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Deakin University Geelong, Victoria
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Address [1]
318015
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Country [1]
318015
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Australia
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Primary sponsor type
Hospital
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Name
Dept. Surgery. Barwon Health
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Address
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Country
Australia
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Secondary sponsor category [1]
320357
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None
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Name [1]
320357
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Address [1]
320357
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Country [1]
320357
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Ethics approval
Ethics application status
Not yet submitted
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Ethics committee name [1]
316675
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Barwon Health HREC
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Ethics committee address [1]
316675
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http://www.barwonhealth.org.au/research/column-1/regi
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Ethics committee country [1]
316675
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Australia
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Date submitted for ethics approval [1]
316675
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31/01/2025
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Approval date [1]
316675
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Ethics approval number [1]
316675
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Summary
Brief summary
This is study aimed at determining whether propylene glycol (a water soluble food additive) is effective in reducing the number of bubbles at colonoscopy, thereby improving visualisation. The Propylene glycol will be administered into the colon via the colonoscope.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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A/Prof Douglas Stupart
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Address
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Dept. Surgery, University Hospital Geelong, Bellarine Street, Geelong, 3220
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Country
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Australia
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Phone
138622
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+61 3 4215 2001
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Fax
138622
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Email
138622
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[email protected]
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Contact person for public queries
Name
138623
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Douglas Stupart
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Address
138623
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Dept. Surgery, University Hospital Geelong, Bellarine Street, Geelong, 3220
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Country
138623
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Australia
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Phone
138623
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+61 3 4215 2001
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Fax
138623
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Email
138623
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[email protected]
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Contact person for scientific queries
Name
138624
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Douglas Stupart
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Address
138624
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Dept. Surgery, University Hospital Geelong, Bellarine Street, Geelong, 3220
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Country
138624
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Australia
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Phone
138624
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+61 3 4215 2001
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Fax
138624
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Email
138624
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[email protected]
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Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
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Investigators and any researchers who request it for any ethically valid reason.
Conditions for requesting access:
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-
What individual participant data might be shared?
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Number of bubbles seen
What types of analyses could be done with individual participant data?
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We would make the data available to any researchers who request it for any ethically valid reason, including (but not limited to) meta- analyses and power calculations for further studies
When can requests for individual participant data be made (start and end dates)?
From:
From the time of last patient recruitment until five years later.
To:
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Where can requests to access individual participant data be made, or data be obtained directly?
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Principle investigator. Douglas.Stupart@Deakin .edu.au
Are there extra considerations when requesting access to individual participant data?
No
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.
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