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Trial registered on ANZCTR


Registration number
ACTRN12617001150336
Ethics application status
Approved
Date submitted
21/07/2017
Date registered
7/08/2017
Date last updated
7/08/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Influence of Simethicone added to the rinse water during colonoscopies on polyp-detection rates
Scientific title
Influence of Simethicone added to the rinse water during colonoscopies on polyp-detection rates: a cohort study utilising routine quality data
Secondary ID [1] 292486 0
Nil known
Universal Trial Number (UTN)
U1111-1199-6336
Trial acronym
Simethicone use and polyp detection rates
Linked study record

Health condition
Health condition(s) or problem(s) studied:
need to undergo routine colonoscopy 304113 0
Condition category
Condition code
Oral and Gastrointestinal 303445 303445 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The effect of adding simethicone to the rinse solution used during routine colonoscopies was studied in a cohort study. Simethicone (approx 50 mg/100 cc) was added to the rinse solution. The rinse solution consists of pharmaceutical grade sterile water and is used to clean the lense of the endoscope and flush material from the surface of mucosa. Medical record review of procedures was performed for a 5 day period from 29 May 2017 to 2 June 2017 when Simethicone was discontinued. Medical record review of procedures was also performed from 28 May 2016 to 28 May 2017 (12 months prior to discontinuation) and from 3 June 2017 to 8 July 2017 (5 weeks following re-introduction).
Intervention code [1] 298665 0
Not applicable
Comparator / control treatment
polyp detection rates were continuously measured and the effects of discontinued use and reintroduction of simethicone use studied.

For 5 days from 29 May 2017 to 2 June 2017
Control group
Active

Outcomes
Primary outcome [1] 302822 0
polyp-detection rates via retrospective electronic medical record review
Timepoint [1] 302822 0
during colonoscopy
Secondary outcome [1] 337169 0
Quality rating of the bowel preparation via electronic medical record review
Timepoint [1] 337169 0
during colonoscopy

Eligibility
Key inclusion criteria
Consecutive patients undergoing colonoscopy during a 12 month time period from 29 May 2016 till 28 May 2017, for 5 days between 29 May 2017 and 2 June 2017 and for 5 weeks from 2 3 June 2017 until 8 July 2017 at the Department of Gastroenterology at the Princess Alexandra Hospital.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
emergency procedures

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Retrospective
Statistical methods / analysis
The polyp-detection rates during a 12 month time period were assessed and compared when simethicone was routinely administered versus when the use of simethicone was discontinued for 5 days and the effects monitored after re-introduction of simethicone. Chi=square testing was used.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
29/05/2016
Date of last participant enrolment
Anticipated
Actual
3/07/2017
Date of last data collection
Anticipated
Actual
3/07/2017
Sample size
Target
3000
Accrual to date
Final
3508
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 8574 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 16679 0
4102 - Woolloongabba

Funding & Sponsors
Funding source category [1] 297055 0
Hospital
Name [1] 297055 0
Princess Alexandra Hospital
Country [1] 297055 0
Australia
Primary sponsor type
Hospital
Name
Princess Alexandra Hospital, Brisbane
Address
199 Ipswich Rd
Woolloongabba, Brisbane, QLD 4102
Country
Australia
Secondary sponsor category [1] 296060 0
None
Name [1] 296060 0
Address [1] 296060 0
Country [1] 296060 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298239 0
Metro South Hospital and Health Service Ethics
Ethics committee address [1] 298239 0
199 Ipswich Rd
Woolloongabba, QLD 4102
Ethics committee country [1] 298239 0
Australia
Date submitted for ethics approval [1] 298239 0
20/07/2017
Approval date [1] 298239 0
01/08/2017
Ethics approval number [1] 298239 0
HREC/17/QPAH

Summary
Brief summary
The effects of simethicone added to the rinse solution during colonoscopies as antifoaming agent with regard to polyp detection rates is poorly studied. We thus aim to quantitate the effects of simethicone during a cohort study when for a defined time period the practice to routinely add simethicone to the rinse solution was discontinued and later re-introduced. Since this change was not communicated to endoscopists they were blinded with regard to this change.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 76438 0
Prof Gerald Holtmann
Address 76438 0
Department of Gastroenterology & Hepatology
Princess Alexandra Hospital, Brisbane
Ipswich Rd
Woolloongabba, QLD 4102
AUSTRALIA
Country 76438 0
Australia
Phone 76438 0
+61731762701
Fax 76438 0
+61731765111
Email 76438 0
[email protected]
Contact person for public queries
Name 76439 0
Gerald Holtmann
Address 76439 0
Department of Gastroenterology & Hepatology
Princess Alexandra Hospital, Brisbane
Ipswich Rd
Woolloongabba, QLD 4102
AUSTRALIA
Country 76439 0
Australia
Phone 76439 0
+61731762701
Fax 76439 0
+61731765111
Email 76439 0
[email protected]
Contact person for scientific queries
Name 76440 0
Gerald Holtmann
Address 76440 0
Department of Gastroenterology & Hepatology
Princess Alexandra Hospital, Brisbane
Ipswich Rd
Woolloongabba, QLD 4102
AUSTRALIA
Country 76440 0
Australia
Phone 76440 0
+61731765111
Fax 76440 0
+61731765111
Email 76440 0
[email protected]

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