Colonic PolypNCT01395173
Position Changes During Colonoscope Withdrawal and Polyp Detection
A study testing Position change and Standard in people with Colonic Polyp, run by University of British Columbia at 1 site in Canada.
Trial summary
The purpose of this study is to determine whether position changes during colonoscope withdrawal affects polyp detection rate. We hypothesize that positions change during scope withdrawal will increase polyp detection rate. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Colonic Polyp
- What is being tested?
- Position change and Standard
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 776 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2011to Dec 2013
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Outpatients undergoing colonoscopy
- Age 40 or greater
Who cannot join
- Inpatient colonoscopy
- Unable to provide informed consent
- Unable to complete colonoscopy to cecum
- Previous bowel resection, inflammatory bowel disease, polyposis syndrome
- Musculoskeletal disorder or other mobility issue limiting effective patient position changes
- Inadequate bowel preparation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Position Changes During Colonoscope Withdrawal to Increase Polyp Detection: a Prospective Randomized Trial
The purpose of this study is to determine whether position changes during colonoscope withdrawal affects polyp detection rate. We hypothesize that positions change during scope withdrawal will increase polyp detection rate.
- Conditions
- Colonic Polyp
- Being tested
- Position change, Standard
- Keywords
- detection
- Medical subject headings
- Colonic Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Position changeProcedure or surgery
Patients will be randomly assigned to two groups: Control group (those who will receive standard colonoscopy without position changes) and Position change group (those who will undergo position changes during colonoscope withdrawal during colonoscopy). Subjects in position change group will be asked to shift into three different positions during colonoscope withdrawal.
StandardProcedure or surgery
Subjects will undergo standard colonoscopy without position changes during scope withdrawal.
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | Subject will undergo standard colonoscopy. Receives: Procedure: Standard |
| Position change | Active comparator | Subject will under go standard colonoscopy, but also with position changes during colonoscope withdrawal. Receives: Procedure: Position change |
What is being measured
The primary outcome is the main question the study is designed to answer.
Polyp detection rate
Measured: 6 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2011 (estimated)
- Study startJul 2011
- Primary completionJul 2012
- Study completionDec 2013
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 Colonic PolypStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 776 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jennifer Telford, MD, FRCPC, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01395173
- Sponsor's protocol ID
- H11-00087
- Status last verified
- Sep 2014
- First submitted
- 13 Jul 2011
- Last updated
- 30 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Ou G, Kim E, Lakzadeh P, Tong J, Enns R, Ramji A, Whittaker S, Ko HH, Bressler B, Halparin L, Lam E, Amar J, Telford J. A randomized controlled trial assessing the effect of prescribed patient position changes during colonoscope withdrawal on adenoma detection. Gastrointest Endosc. 2014 Aug;80(2):277-83. doi: 10.1016/j.gie.2014.01.032. Epub 2014 Mar 12.
PubMed 24629419
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Position Changes During Colonoscope Withdrawal to Increase Polyp Detection: a Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT01395173
- Acronym / sponsor ID
- H11-00087
- Conditions
- Colonic Polyp
- Keywords
- detection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 776 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Jul 2012 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 15 Jul 2011 (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 purpose of this study is to determine whether position changes during colonoscope withdrawal affects polyp detection rate. We hypothesize that positions change during scope withdrawal will increase polyp detection rate.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Procedure: StandardSubject will undergo standard colonoscopy. |
| Position change | Active comparator | Procedure: Position changeSubject will under go standard colonoscopy, but also with position changes during colonoscope withdrawal. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Outpatients undergoing colonoscopy
- Age 40 or greater
Key exclusion criteria (6 listed)
- Inpatient colonoscopy
- Unable to provide informed consent
- Unable to complete colonoscopy to cecum
- Previous bowel resection, inflammatory bowel disease, polyposis syndrome
- Musculoskeletal disorder or other mobility issue limiting effective patient position changes
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 |
|---|---|---|
| Position changePatients will be randomly assigned to two groups: Control group (those who will receive standard colonoscopy without position changes) and Position change group (those who will undergo position changes during colonoscope withdrawal during colonoscopy). Subjects in position change group will be asked to shift into three different positions during colonoscope withdrawal. | Procedure or surgery | Position change |
| StandardSubjects will undergo standard colonoscopy without position changes during scope withdrawal. | Procedure or surgery | Control |
Primary outcome
Polyp detection rate
Time frame: 6 minutes
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 30 Sep 2014.
- Derived from this study: PubMed 24629419Ou G, Kim E, Lakzadeh P, Tong J, Enns R, Ramji A, Whittaker S, Ko HH, Bressler B, Halparin L, Lam E, Amar J, Telford J. A randomized controlled trial assessing the effect of prescribed patient position changes during colonoscope withdrawal on adenoma detection. Gastrointest Endosc. 2014 Aug;80(2):277-83. doi: 10.1016/j.gie.2014.01.032. Epub 2014 Mar 12.
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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.
Jennifer Telford, MD, FRCPC principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Position change and Standard in people with Colonic Polyp, run by University of British Columbia at 1 site in Canada.
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 2 inclusion and 6 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 30 Sep 2014. 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 Canada. 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. Some participants in this study may receive a placebo. 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?
Polyp detection rate (time frame: 6 minutes). 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 NCT01395173, 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 30 Sep 2014; AzTrials last refreshed its copy on 2 Nov 2026.