Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000424707
Ethics application status
Approved
Date submitted
11/04/2013
Date registered
16/04/2013
Date last updated
16/04/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
In adult patients undergoing colonoscopy, does retroflexion of the colonoscope in the right colon compared to standard forward viewing endoscopy increase the detection of adenomatous colonic polyps.
Scientific title
Adult patients undergoing colonoscopy, does retroflexion of the colonoscope in the right colon compared to standard forward viewing endoscopy increase the detection of adenomatous colonic polyps.
Secondary ID [1] 282314 0
Nil
Universal Trial Number (UTN)
U1111-1141-7971
Trial acronym
n/a
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Right sided colonic adenomatous polyps 288856 0
Condition category
Condition code
Oral and Gastrointestinal 289198 289198 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Cancer 289222 289222 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Retroflexion of the colonoscope in the right colon which is standard practice for many endoscopists despite the paucity of data anaecdotally is thought to improve the detection of polyps behind folds that may not been seen on standard forward view withdrawal. The procedure duration for colonoscopy is approximately 20 minutes with retroflexion only adding an extra 1-2mins to the total procedure time and is standard practice for the endoscopists involved.
The process is undertaken in each patient once.
Intervention code [1] 286928 0
Diagnosis / Prognosis
Intervention code [2] 286964 0
Early detection / Screening
Comparator / control treatment
The endoscopist will document any polyps seen on standard forward view assessment of the right colon.
The approximate duration of the procedure is 20 minutes and is undertaken in each patient once.
The patients all undergo the same maneuver within the same session and the practice of retroflexion is standard practice for all endoscopists involved.
Control group
Active

Outcomes
Primary outcome [1] 289309 0
Adenoma detection rate
Timepoint [1] 289309 0
At the time of endoscopy
Secondary outcome [1] 302203 0
Success rate of performing right sided colonic retroflexion
Timepoint [1] 302203 0
During the procedure the endoscopist will record successful retroflexion in the right colon if when the maneuver is performed the proximal part of the colonoscope is visualized.
Secondary outcome [2] 302204 0
Safety of performing colonic retroflexion.
This is assessed immediately post procedure and up to 30 days following at outpatient reviews. Include any complications from the procedure including perforation, or pain requiring admission.
Timepoint [2] 302204 0
Immediately post procedure and upto 30days following.

Eligibility
Key inclusion criteria
Adults aged >18.
Complete colonoscopy
Satisfactory or good bowel preparation.
Operators: Consultant gastroenterologists
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with active underlying inflammatory bowel disease or polyposis syndromes.
Poor bowel preparation at the time of colonoscopy.
Previous surgical resection of the right colon.
Incomplete colonoscopy
Polyp specimen not retrieved for analysis.

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
Safety/efficacy
Statistical methods / analysis
The primary outcome is to assess whether retroflexion in the right colon improves the detection of adenomas in comparison to standard forward viewing and a previous study2 found that 33% of patients had polyps detected on forward view. We hypothesize that the detection rate can be improved by at least 5%.
One group only is required as the technique will be identical for all subjects. With a one sided analysis, a significance level of 0.05, and a power of 0.8 the sample size will be 1172 subjects. Allowing for a 10% retroflexion failure rate2, the number of subjects recruited will be 1290.
The primary analysis will be that of comparing proportions. Confidence intervals will be calculated, and Chi square or Fisher’s exact tests, as appropriate, used to compare other categorical data using statistical software (Stata™version 10). A p-value of 0.05 will be considered to be statistically significant.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/05/2013
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
1290
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
TAS,VIC
Recruitment hospital [1] 862 0
Austin Health - Heidelberg Repatriation Hospital - Heidelberg West
Recruitment hospital [2] 863 0
The Alfred - Prahran
Recruitment hospital [3] 864 0
Calvary Health Care Tasmania - Launceston campus - Launceston
Recruitment hospital [4] 865 0
Launceston General Hospital - Launceston
Recruitment hospital [5] 866 0
Royal Hobart Hospital - Hobart
Recruitment hospital [6] 867 0
Calvary Health Care Tasmania - Hobart - Lenah Valley
Recruitment hospital [7] 868 0
Warringal Private Hospital - Heidelberg
Recruitment hospital [8] 869 0
John Fawkner Private Hospital - Coburg
Recruitment hospital [9] 870 0
St Albans Endoscopy Centre - St Albans
Recruitment postcode(s) [1] 6676 0
3084 - Heidelberg
Recruitment postcode(s) [2] 6677 0
3181 - Prahran
Recruitment postcode(s) [3] 6678 0
7250 - Launceston
Recruitment postcode(s) [4] 6679 0
7008 - Lenah Valley
Recruitment postcode(s) [5] 6680 0
7000 - Hobart
Recruitment postcode(s) [6] 6681 0
3058 - Coburg
Recruitment postcode(s) [7] 6682 0
3021 - St Albans

Funding & Sponsors
Funding source category [1] 287075 0
Hospital
Name [1] 287075 0
Department of Gastroenterology Austin health
Country [1] 287075 0
Australia
Primary sponsor type
Hospital
Name
Austin Health Department of Gastroenterology
Address
Austin Health
145 Studley Road
Heidleberg Victoria 3084
Country
Australia
Secondary sponsor category [1] 285850 0
None
Name [1] 285850 0
Address [1] 285850 0
Country [1] 285850 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289090 0
Austin HREC
Ethics committee address [1] 289090 0
145 Studley Road
PO BOX 5555 Heidelberg
Victoria Australia 3084
Ethics committee country [1] 289090 0
Australia
Date submitted for ethics approval [1] 289090 0
Approval date [1] 289090 0
07/12/2012
Ethics approval number [1] 289090 0
H2012/04883

Summary
Brief summary
This study aims to assess whether the use of a 'retroflexion' technique improves adenoma (tumour) detection in the right colon.
Who is it for? You may be eligible to join this study if you are aged 18 years or above and are scheduled to undergo a complete colonoscopy.
Trial details All participants in this trial will undergo a single colonoscopy which includes a technique known as 'retroflexion' in the right colon. This is standard practice for many endoscopists. The procedure duration is approximately 20 minutes with retroflexion only adding an extra 1-2mins to the total procedure time. Adenoma detection rate from the standard forward view assessment will be compared to that from retroflexion. It is thought that retroflexion may improve the detection of polyps behind folds that may not be seen on standard forward view.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 39202 0
Dr Sujievvan Chandran
Address 39202 0
Austin Health
145 Studley Road
Heidelberg Victoria 3084
Country 39202 0
Australia
Phone 39202 0
+61 03 94965708
Fax 39202 0
Email 39202 0
[email protected]
Contact person for public queries
Name 39203 0
Dr Sujievvan Chandran
Address 39203 0
Austin Health
145 Studley Road
Heidelberg Victoria 3084
Country 39203 0
Australia
Phone 39203 0
+61 03 94965708
Fax 39203 0
Email 39203 0
[email protected]
Contact person for scientific queries
Name 39204 0
Dr Sujievvan Chandran
Address 39204 0
Austin Health
145 Studley Road
Heidelberg Victoria 3084
Country 39204 0
Australia
Phone 39204 0
+61 03 94965708
Fax 39204 0
Email 39204 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
SourceTitleYear of PublicationDOI
EmbaseRight-sided adenoma detection with retroflexion versus forward-view colonoscopy.2015https://dx.doi.org/10.1016/j.gie.2014.08.039
N.B. These documents automatically identified may not have been verified by the study sponsor.