PolypsNCT00234650
Adenoma Detection Rate With Position Change at Colonoscopy
A study testing Colonoscopy in people with Polyps, run by London North West Healthcare NHS Trust at 1 site in United Kingdom.
Trial summary
The hypothesis to be tested is that position changes during the withdrawal phase of colonoscopy leads to a higher adenoma (polyp) detection rate because of better distension of the colon. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Polyps
- What is being tested?
- Colonoscopy
- Type of treatment
- Surgery or procedure
- How many people
- 130 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2005to Sep 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients referred ot colonoscopy, age between 50 - 70 years
Who cannot join
- Patients with colorectal cancer, previous colonic surgery, active colitis and musculoskeletal problems Patients may also be excluded after the first insertion, if painful, routine care will proceed
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
North West London NHS Trust
London, Middlesex, HA1 3UJ
About this study
Official title: Evaluation of the Effect of Position Change During the Withdrawal Phase of Colonoscopy on Adenoma Detection Rate
The hypothesis to be tested is that position changes during the withdrawal phase of colonoscopy leads to a higher adenoma (polyp) detection rate because of better distension of the colon. Since adenomas are precancerous lesions the enhanced adenoma detection will increase the success of colorectal cancer screening programmes. This study will provide evidence for the value of position changes and encourage endoscopist to adopt position change as a routine in their practice.
May 2007: protocol amendment to include additional prospective analysis using High Definition TV (HDTV).
Read the detailed description
Colorectal cancer is the second commonest cause of cancer death. In a majority of cases it is preceded by a precancerous lesion called an adenoma (commonly known as polyp). Detection and removal of adenomas at colonoscopy has been shown to reduce mortality from colorectal cancer. The success of the impending colorectal cancer screening programme to reduce cancer mortality in an average-risk population depends on optimal adenoma detection at colonoscopy. The detection of adenomas has been shown to vary between different endoscopist. Some of the factors that have been reported to affect adenoma detection rates included the time spent viewing, the adequacy of the bowel preparation and the time spent cleaning the colonic mucosa of excess fluid. Careful examination of proximal side of flexures, folds and valves by the endoscopist is equally important. However, even with careful examination adenoma detection rates have been shown to vary between endoscopist from 8.6% to 15.9%. Previous experience and training may be contributed to this difference. Some endoscopist adopt regular changes in position during the procedure to maximize distension of the colon. Better luminal distension enhances mucosal views for detection of the smaller adenomas. The validity of this approach has never been tested and we propose that this factor may contribute to the differences in adenoma detection rates.
Patients will be randomised to either position 1 first then position 2 or vice versa and examined twice. During one withdrawal the colon will be examined with the participant in the left lateral position only (position 1) or with position changes (position 2)or vice versa.
May 2007: protocol amendment to include additional prospective analysis using High Definition TV (HDTV). No further patient data collection involved.
- Conditions
- Polyps
- Being tested
- Colonoscopy
- Keywords
- position change, adenoma, colonoscopy
- Medical subject headings
- Polyps, Adenoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ColonoscopyProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
adenoma detection rate for position 1 compared to position 2
Secondary outcomes (1)
percentage of adenomas detected in all the participants for each position
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2005 (estimated)
- Study startOct 2005
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PolypsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- London North West Healthcare NHS Trust
- Sponsor type
- University, hospital or other
- Investigators
- Brian Saunders, MD, Principal investigator, St Mark's Hospital, North West London NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00234650
- Sponsor's protocol ID
- 05/CO05/15
- Status last verified
- Dec 2008
- First submitted
- 5 Oct 2005
- Last updated
- 2 Apr 2009
- Results posted
- No
Publications
East JE, Bassett P, Arebi N, Thomas-Gibson S, Guenther T, Saunders BP. Dynamic patient position changes during colonoscope withdrawal increase adenoma detection: a randomized, crossover trial. Gastrointest Endosc. 2011 Mar;73(3):456-63. doi: 10.1016/j.gie.2010.07.046. Epub 2010 Oct 15.
PubMed 20950801
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Position Change During the Withdrawal Phase of Colonoscopy on Adenoma Detection Rate
- ClinicalTrials.gov ID
- NCT00234650
- Acronym / sponsor ID
- 05/CO05/15
- Conditions
- Polyps
- Keywords
- position change, adenoma, colonoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- London North West Healthcare NHS TrustUniversity, hospital or other
- Study start
- Oct 2005
- Study completion
- Sep 2007 (actual)
- First posted
- 7 Oct 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The hypothesis to be tested is that position changes during the withdrawal phase of colonoscopy leads to a higher adenoma (polyp) detection rate because of better distension of the colon. Since adenomas are precancerous lesions the enhanced adenoma detection will increase the success of colorectal cancer screening programmes. This study will provide evidence for the value of position changes and encourage endoscopist to adopt position change as a routine in their practice.
May 2007: protocol amendment to include additional prospective analysis using High Definition TV (HDTV).
Detailed description
Colorectal cancer is the second commonest cause of cancer death. In a majority of cases it is preceded by a precancerous lesion called an adenoma (commonly known as polyp). Detection and removal of adenomas at colonoscopy has been shown to reduce mortality from colorectal cancer. The success of the impending colorectal cancer screening programme to reduce cancer mortality in an average-risk population depends on optimal adenoma detection at colonoscopy. The detection of adenomas has been shown to vary between different endoscopist. Some of the factors that have been reported to affect adenoma detection rates included the time spent viewing, the adequacy of the bowel preparation and the time spent cleaning the colonic mucosa of excess fluid. Careful examination of proximal side of flexures, folds and valves by the endoscopist is equally important. However, even with careful examination adenoma detection rates have been shown to vary between endoscopist from 8.6% to 15.9%. Previous experience and training may be contributed to this difference. Some endoscopist adopt regular changes in position during the procedure to maximize distension of the colon. Better luminal distension enhances mucosal views for detection of the smaller adenomas. The validity of this approach has never been tested and we propose that this factor may contribute to the differences in adenoma detection rates.
Patients will be randomised to either position 1 first then position 2 or vice versa and examined twice. During one withdrawal the colon will be examined with the participant in the left lateral position only (position 1) or with position changes (position 2)or vice versa.
May 2007: protocol amendment to include additional prospective analysis using High Definition TV (HDTV). No further patient data collection involved.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients referred ot colonoscopy, age between 50 - 70 years
Key exclusion criteria (1 listed)
- Patients with colorectal cancer, previous colonic surgery, active colitis and musculoskeletal problems Patients may also be excluded after the first insertion, if painful, routine care will proceed
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Colonoscopy | Procedure or surgery | – |
Primary outcome
adenoma detection rate for position 1 compared to position 2
1 secondary outcome
percentage of adenomas detected in all the participants for each position
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2009.
- Derived from this study: PubMed 20950801East JE, Bassett P, Arebi N, Thomas-Gibson S, Guenther T, Saunders BP. Dynamic patient position changes during colonoscope withdrawal increase adenoma detection: a randomized, crossover trial. Gastrointest Endosc. 2011 Mar;73(3):456-63. doi: 10.1016/j.gie.2010.07.046. Epub 2010 Oct 15.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brian Saunders, MD principal investigator
St Mark's Hospital, North West London NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Colonoscopy in people with Polyps, run by London North West Healthcare NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
adenoma detection rate for position 1 compared to position 2. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00234650, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2009.