Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000884404p
Ethics application status
Submitted, not yet approved
Date submitted
12/06/2025
Date registered
13/08/2025
Date last updated
13/08/2025
Date data sharing statement initially provided
13/08/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Does Acetic acid Chromoendoscopy allow Improved Detection of Sessile Serrated Lesions? The ACID-SSL Trial
Scientific title
Acetic Acid Chromoendoscopy for Detection of Sessile Serrated Lesions During Screening Colonoscopy - A Randomized Controlled Trial
Secondary ID [1] 314638 0
None
Universal Trial Number (UTN)
Trial acronym
ACID-SSL Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Serrated polyps 337792 0
Condition category
Condition code
Oral and Gastrointestinal 334136 334136 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
The intervention group underwent acetic acid chromoendoscopy using a 0.5% solution that was prepared fresh daily by diluting 3% or 5% acetic acid with normal saline. The concentration was determined based on preliminary dose-finding studies that balanced mucolysis effectiveness with minimal mucosal irritation. During withdrawal, approximately 30-50 mL of solution was applied to each colonic segment (cecum/ascending, transverse, descending/sigmoid) via a foot pump (Olympus). The timing is immediate (no delay).
The procedure usually last 20minutes
The Gastroenterologist using a foot pump administers the solution
Intervention code [1] 331267 0
Early detection / Screening
Comparator / control treatment
The control group is the standard of care (current colonscopy practice) received the same volume of normal saline irrigation using identical technique, ensuring similar mechanical mucus removal without chemical enhancement.
The volume of normal saline can be up to 250mls
The procedure usually last 20minutes
The Gastroenterologist using a foot pump administers the normal saline
Control group
Placebo

Outcomes
Primary outcome [1] 341788 0
Detection rate of sessile serrated lesions
Timepoint [1] 341788 0
Cumulative data will be assessed once all participants have undergone endoscopy,
Secondary outcome [1] 448702 0
Evaluate adenoma detection rates between groups
Timepoint [1] 448702 0
Cumulative data will be assessed once all participants have undergone endoscopy and the mean between groups at the end of the study

Eligibility
Key inclusion criteria
1. Adults aged 18 years and older
2. Patients of Port Macquarie Gastroenterology
3. Scheduled for colonoscopy at Port Macquarie Private Hospital
4. Undergoing first-time or surveillance / screening colonoscopy
5. Average-risk individuals due for screening per national guidelines
6. Able to provide informed consent
7. Adequate bowel preparation anticipated
8. Complete colonoscopy to cecum expected
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Inflammatory bowel disease
2. Previous colorectal resection
3. Hereditary polyposis syndromes, Familial Adenomatous Polyposis (FAP) and Hereditary Nonpolyposis Colorectal Cancer (HNPCC).
4. Personal history of colorectal cancer
5. Pregnancy or lactation
6. Known allergy to acetic acid
7. ASA class IV-V

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sequentially numbered, computer allocation at time of the procedure
Stored securely at Port Macquarie Gastroenterology
Allocated immediately before colonoscopy
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer-generated sequence with variable block sizes (4, 6, 8)
Stratification by endoscopist (individual endoscopist)
1:1 allocation ratio
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/09/2025
Actual
Date of last participant enrolment
Anticipated
31/07/2026
Actual
Date of last data collection
Anticipated
1/08/2026
Actual
Sample size
Target
1032
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 319201 0
Other
Name [1] 319201 0
Port Macquarie Gastroenterology
Country [1] 319201 0
Australia
Primary sponsor type
Other
Name
Port Macquarie Gastroenterology
Address
Country
Australia
Secondary sponsor category [1] 321668 0
None
Name [1] 321668 0
Address [1] 321668 0
Country [1] 321668 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 317781 0
Ramsay Health Care Human Research Ethics Committee A
Ethics committee address [1] 317781 0
Ethics committee country [1] 317781 0
Australia
Date submitted for ethics approval [1] 317781 0
11/06/2025
Approval date [1] 317781 0
Ethics approval number [1] 317781 0

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

Contacts
Principal investigator
Name 142130 0
A/Prof Stuart Kostalas
Address 142130 0
Port Macquarie Gastroenterology Shop 22 15 Chancellors Dr, Thrumster, NSW, 2444
Country 142130 0
Australia
Phone 142130 0
+61488533011
Fax 142130 0
Email 142130 0
[email protected]
Contact person for public queries
Name 142131 0
Stuart Kostalas
Address 142131 0
Port Macquarie Gastroenterology Shop 22 15 Chancellors Dr, Thrumster, NSW, 2444
Country 142131 0
Australia
Phone 142131 0
+61488533011
Fax 142131 0
Email 142131 0
[email protected]
Contact person for scientific queries
Name 142132 0
Stuart Kostalas
Address 142132 0
Port Macquarie Gastroenterology Shop 22 15 Chancellors Dr, Thrumster, NSW, 2444
Country 142132 0
Australia
Phone 142132 0
+61488533011
Fax 142132 0
Email 142132 0
[email protected]

Data sharing statement
Will the study consider sharing 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.