Trial Review

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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
Scientific title
Effect of water soluble defoamer on colonoscopic bubble score in adult patients undergoingr colonoscopy
Secondary ID [1] 313553 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
colonoscopy 336043 0
Condition category
Condition code
Surgery 332668 332668 0 0
Other surgery
Oral and Gastrointestinal 332608 332608 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
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.
Intervention code [1] 330144 0
Early detection / Screening
Comparator / control treatment
Nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 340123 0
Colonoscopic bubble score
Timepoint [1] 340123 0
Immediate
Secondary outcome [1] 442848 0
Nil
Timepoint [1] 442848 0
Nil

Eligibility
Key inclusion criteria
Adult patients undergoing colonoscopy at University Hospital Geelong.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Under age 18.
Unable to understand consent.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/02/2025
Actual
Date of last participant enrolment
Anticipated
30/07/2025
Actual
Date of last data collection
Anticipated
30/07/2025
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 318015 0
University
Name [1] 318015 0
Deakin University Geelong, Victoria
Country [1] 318015 0
Australia
Primary sponsor type
Hospital
Name
Dept. Surgery. Barwon Health
Address
Country
Australia
Secondary sponsor category [1] 320357 0
None
Name [1] 320357 0
Address [1] 320357 0
Country [1] 320357 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 316675 0
Barwon Health HREC
Ethics committee address [1] 316675 0
Ethics committee country [1] 316675 0
Australia
Date submitted for ethics approval [1] 316675 0
31/01/2025
Approval date [1] 316675 0
Ethics approval number [1] 316675 0

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

Contacts
Principal investigator
Name 138622 0
A/Prof Douglas Stupart
Address 138622 0
Dept. Surgery, University Hospital Geelong, Bellarine Street, Geelong, 3220
Country 138622 0
Australia
Phone 138622 0
+61 3 4215 2001
Fax 138622 0
Email 138622 0
[email protected]
Contact person for public queries
Name 138623 0
Douglas Stupart
Address 138623 0
Dept. Surgery, University Hospital Geelong, Bellarine Street, Geelong, 3220
Country 138623 0
Australia
Phone 138623 0
+61 3 4215 2001
Fax 138623 0
Email 138623 0
[email protected]
Contact person for scientific queries
Name 138624 0
Douglas Stupart
Address 138624 0
Dept. Surgery, University Hospital Geelong, Bellarine Street, Geelong, 3220
Country 138624 0
Australia
Phone 138624 0
+61 3 4215 2001
Fax 138624 0
Email 138624 0
[email protected]

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:
• Investigators and any researchers who request it for any ethically valid reason.

Conditions for requesting access:
• -

What individual participant data might be shared?
• Number of bubbles seen

What types of analyses could be done with individual participant data?
• 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:
-

Where can requests to access individual participant data be made, or data be obtained directly?
• 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.