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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
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Scientific title
Influence of Simethicone added to the rinse water during colonoscopies on polyp-detection rates: a cohort study utilising routine quality data
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Secondary ID [1]
292486
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Nil known
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Universal Trial Number (UTN)
U1111-1199-6336
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Trial acronym
Simethicone use and polyp detection rates
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
need to undergo routine colonoscopy
304113
0
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Condition category
Condition code
Oral and Gastrointestinal
303445
303445
0
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
Observational
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Patient registry
False
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Target follow-up duration
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Target follow-up type
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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).
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Intervention code [1]
298665
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Not applicable
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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
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Control group
Active
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Outcomes
Primary outcome [1]
302822
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polyp-detection rates via retrospective electronic medical record review
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Assessment method [1]
302822
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Timepoint [1]
302822
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during colonoscopy
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Secondary outcome [1]
337169
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Quality rating of the bowel preparation via electronic medical record review
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Assessment method [1]
337169
0
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Timepoint [1]
337169
0
during colonoscopy
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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.
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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
emergency procedures
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Study design
Purpose
Natural history
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Duration
Cross-sectional
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Selection
Defined population
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Timing
Retrospective
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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.
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
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Actual
29/05/2016
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Date of last participant enrolment
Anticipated
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Actual
3/07/2017
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Date of last data collection
Anticipated
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Actual
3/07/2017
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Sample size
Target
3000
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Accrual to date
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Final
3508
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment hospital [1]
8574
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Princess Alexandra Hospital - Woolloongabba
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Recruitment postcode(s) [1]
16679
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4102 - Woolloongabba
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Funding & Sponsors
Funding source category [1]
297055
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Hospital
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Name [1]
297055
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Princess Alexandra Hospital
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Address [1]
297055
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199 Ipswich Rd
Woolloongabba, Brisbane, QLD 4102
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Country [1]
297055
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Australia
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Primary sponsor type
Hospital
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Name
Princess Alexandra Hospital, Brisbane
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Address
199 Ipswich Rd
Woolloongabba, Brisbane, QLD 4102
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Country
Australia
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Secondary sponsor category [1]
296060
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None
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Name [1]
296060
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Address [1]
296060
0
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Country [1]
296060
0
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
298239
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Metro South Hospital and Health Service Ethics
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Ethics committee address [1]
298239
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199 Ipswich Rd Woolloongabba, QLD 4102
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Ethics committee country [1]
298239
0
Australia
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Date submitted for ethics approval [1]
298239
0
20/07/2017
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Approval date [1]
298239
0
01/08/2017
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Ethics approval number [1]
298239
0
HREC/17/QPAH
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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.
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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
76438
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Prof Gerald Holtmann
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Address
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Department of Gastroenterology & Hepatology
Princess Alexandra Hospital, Brisbane
Ipswich Rd
Woolloongabba, QLD 4102
AUSTRALIA
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Country
76438
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Australia
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Phone
76438
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+61731762701
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Fax
76438
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+61731765111
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Email
76438
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g.holtmann@uq.edu.au
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Contact person for public queries
Name
76439
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Gerald Holtmann
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Address
76439
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Department of Gastroenterology & Hepatology
Princess Alexandra Hospital, Brisbane
Ipswich Rd
Woolloongabba, QLD 4102
AUSTRALIA
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Country
76439
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Australia
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Phone
76439
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+61731762701
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Fax
76439
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+61731765111
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Email
76439
0
g.holtmann@uq.edu.au
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Contact person for scientific queries
Name
76440
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Gerald Holtmann
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Address
76440
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Department of Gastroenterology & Hepatology
Princess Alexandra Hospital, Brisbane
Ipswich Rd
Woolloongabba, QLD 4102
AUSTRALIA
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Country
76440
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Australia
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Phone
76440
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+61731765111
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Fax
76440
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+61731765111
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Email
76440
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g.holtmann@uq.edu.au
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No information has been provided regarding IPD availability
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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