Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000260527
Ethics application status
Approved
Date submitted
1/06/2006
Date registered
28/06/2006
Date last updated
28/06/2006
Type of registration
Retrospectively registered

Titles & IDs
Public title
Peppermint oil for flexible sigmoidoscopy pre-medication
Scientific title
Does pre-medication with peppermint oil improve adenoma detection rate in a flexible sigmoidoscopy based colorectal cancer screening study?
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Colorectal cancer screening 1236 0
Condition category
Condition code
Cancer 1321 1321 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All attenders at a flexible sigmoidoscopy based colorectal cancer screening group are invited to participate in this substudy. Participants are randomly allocated to receive a peppermint oil capsule taken orally at least 30 minutes prior to undergoing sigmoidoscopy. Additionally, the same participants are randomly allocated to recieve one (standard care) or two phosphate enemas per rectum as bowel preparation also at least 30 minutes prior toprior to sigmoidoscopy. Both interventions are single administrations only on the day of sigmoidoscopy.
Intervention code [1] 1083 0
Treatment: Drugs
Comparator / control treatment
Placebo
Control group
Placebo

Outcomes
Primary outcome [1] 1806 0
Adenoma detection rate at sigmoidoscopy. Polyp detection is determined immediately at sigmoidoscopy.Pathology reports 5-7 days later are obtained to determine if the polyp was adenomatous.
Timepoint [1] 1806 0
Secondary outcome [1] 3164 0
Insertion depth
Timepoint [1] 3164 0
Time point: at time of sigmoidoscopy
Secondary outcome [2] 3165 0
Pain score
Timepoint [2] 3165 0
Time point: immediately following sigmoidoscopy
Secondary outcome [3] 3166 0
Faecal clearance score
Timepoint [3] 3166 0
Time point: assessed by independent blinded reviewer based on photo taken at time of sigmoidoscopy

Eligibility
Key inclusion criteria
All participants of a flexible sigmoidoscopy based colorectal cancer screening program.
Minimum age
55 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
If allergy to peppermint oil, severe symptomatic gastro-oesophageal reflux disease, use of any analgesics on the day of the sigmoidoscopy prior to the procedure.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Use of numbered containers
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by selection of folded, numbered pieces of paper from a container
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
2/05/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1446 0
Hospital
Name [1] 1446 0
Fremantle Hospital
Country [1] 1446 0
Australia
Primary sponsor type
Individual
Name
Dr Charlie Viiala
Address
Country
Secondary sponsor category [1] 1279 0
Individual
Name [1] 1279 0
Professor John Olynyk
Address [1] 1279 0
Country [1] 1279 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2819 0
Fremantle Hospital
Ethics committee address [1] 2819 0
Ethics committee country [1] 2819 0
Australia
Date submitted for ethics approval [1] 2819 0
Approval date [1] 2819 0
22/12/2005
Ethics approval number [1] 2819 0
05/447

Summary
Brief summary
The screening program with flexible sigmoidoscopy has been operating for 10 years. Up to 40% of participants do not reattend, largely due to concerns over pain and discomfort and our data indicates that high pain scores and poor bowel cleansing are associated with reduced detection of colonic adenomas. We aim to assess the efficacy of peppermint oil in improving adenoma detection by reducing pain. Additionally, the efficacy of two enemas rather than the standard one enema in improving bowel cleansing and adenoma detectionwill be assessed. Participants, the procedualist, staff interviewing subjects after sigmoidoscopy and the data analyst are blinded to the nature of the interventions. Study will be unblinded following adequate recruitment
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36379 0
Address 36379 0
Country 36379 0
Phone 36379 0
Fax 36379 0
Email 36379 0
Contact person for public queries
Name 10272 0
Charlie Viiala
Address 10272 0
Endoscopy Unit
Fremantle Hospital
Alma St
Fremantle
WA 6160
Country 10272 0
Australia
Phone 10272 0
(08) 9431 2300
Fax 10272 0
(08) 9431 2340
Email 10272 0
[email protected]
Contact person for scientific queries
Name 1200 0
Charlie Viiala
Address 1200 0
Endoscopy Unit
Fremantle Hospital
Alma St
Fremantle
WA 6160
Country 1200 0
Australia
Phone 1200 0
(08) 9431 2300
Fax 1200 0
(08) 9431 2340
Email 1200 0
[email protected]

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.