Colonic AdenomaNCT03355495
R vs L Lateral Decubitus Positioning in Colonoscopy
A study testing Colonoscopy - Position Change in people with Colonic Adenoma and Colonic Cancer, run by Memorial University of Newfoundland at 1 site in Canada.
Trial summary
Colonoscopy continues to be the gold standard in detecting precancerous lesions in the colon. It relies on adequate visualization of the bowel wall to see and remove such lesions. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colonic Adenoma, Colonic Cancer
- What is being tested?
- Colonoscopy - Position Change
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 172 participants
- Where
- 1 siteCanada
- Study dates
- 1 Mar 2019to 30 Jun 2023
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients 18 years of age or older presenting for their scheduled colonoscopy
Who cannot join
- Previous bowel resection
- Unable to stay in either the right or left lateral decubitus position, due to pre-existing musculoskeletal problems, previous hip surgery, etc.
- Refusal to participate
- Inability to provide informed consent
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Health Sciences Centre
St. John's, Newfoundland and Labrador, A1B3V6
Alison M Greene, MD, 7096937334
7096937334
About this study
Official title: A Randomized Controlled Trial Comparing Right vs Left Lateral Decubitus Positioning on Outcomes in Colonoscopy
Colonoscopy continues to be the gold standard in detecting precancerous lesions in the colon. It relies on adequate visualization of the bowel wall to see and remove such lesions. Visualization is improved with luminal distention, and a multitude of studies have been done to determine ways to increase this luminal distention. The investigators theorize that positioning in the Right Lateral Decubitus rather than the Left Lateral Decubitus may be a cost free method to increase luminal distention and, hence, improve visualization in colonoscopy. In the Right Lateral Decubitus position, the sigmoid colon and cecum - both parts of the bowel that are not fixed - air used during colonoscopy will rise in a dependent fashion, increasing luminal distention. In the left lateral decubitus position, the bowel collapses, creating an often difficult area to maneuver and visualize. The investigators would like to compare both positions to determine if it affects outcomes in colonoscopy. In particular, cecal intubation rates and adenoma detection rates.
Read the detailed description
Colonoscopy is considered the gold standard for detecting precancerous lesions in the bowel - providing both diagnostic and therapeutic value. Colonoscopy is, ultimately, operator dependent and relies on adequate visualization of these lesions. A multitude of studies have been done to determine the best way to achieve luminal distention that provides the best visualization to detect and remove adenomas. Recent literature has studied the effect of position changes in colonoscopy. Position changes have been theorized to increase luminal distention in the bowel - improving visualization and maneuverability through the colon. Both air and water are used during colonoscopy, with air rising in a dependent fashion in the colon to the highest point. The standard position to perform colonoscopy is left lateral decubitus. In this position, parts of the bowel collapse as air rises into other parts of the bowel. This includes the sigmoid colon and the cecum, both of which are not fixed and can therefore collapse becoming technically challenging to maneuver around. In the right lateral decubitus position, the air rises into these unfixed areas of bowel and are easier to maneuver. A trial by Vergis et al found that right lateral decubitus resulted in quicker examination times and more comfort in their cohort of patients as opposed to the left lateral decubitus position. The investigators note, however, that the population in which this study took place are not comparable to the patients in Newfoundland and in Canada. The investigators also note a study by Ou et al that found position changes had no effect in adenoma detection. Furthermore, a study by Ball et al found conflicting results with position change increased adenoma detection in the right but not the left side of the colon. Conflicting results between all these trials and the populations used have lead to us question if position changes, a cost free and technically easy intervention, can increase visualization in colonoscopy. The investigators propose a randomized controlled trial that compares positioning patients in the right lateral decubitus or left lateral decubitus to aid in luminal distention and visualization, decreasing cecal intubation time and ultimately increasing adenoma detection rate in colonoscopy.
In this trial, participation in the study will be offered when patients present for their scheduled colonoscopy. The patients will be consented at this time for both the colonoscopy procedure and participation in the trial. Patients who consent to take part will then be randomly assigned to either the right or left lateral decubitus starting position. The colonoscopy will then be done in the usual manner with appropriate sedation. Timing throughout the colonoscopy, the number of polyps found and quality of the visualization will then be recorded during the procedure. Patients will then be debriefed regarding their colonoscopy following the procedure in recovery.
- Conditions
- Colonic Adenoma, Colonic Cancer
- Being tested
- Colonoscopy - Position Change
- Keywords
- Colonoscopy, Cecal Intubation Rate
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colonoscopy - Position ChangeProcedure or surgery
Also called Endoscopy
Colonoscopy is the gold standard for detecting precancerous lesions. We are proposing that changing positions will provide better visualization for detecting such lesions. We will test our intervention of patients positioned in the Right Lateral Decubitus Position to the gold standard of Left Lateral Decubitus Positioning, hypothesizing better visualization in the right lateral decubitus position.
| Study group | Role | What they receive |
|---|---|---|
| Left Lateral Decubitus Position | No intervention | Gold standard positioning for colonoscopy |
| Right Lateral Decubitus Position | Active comparator | Comparing positioning in Right Lateral Decubitus (intervention) for visualization in colonoscopy to the gold standard of Left Lateral Decubitus. Receives: Procedure: Colonoscopy - Position Change |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease in Cecal Intubation Time
The time it takes for a colonoscopist to start a colonoscopy and reach the cecum (endpoint or target area)
Measured: 3 months
Secondary outcomes (2)
Increase in Cecal Intubation Rate
An important indicator in colonoscopy quality, the percentage of times a colonoscopist can reach the cecum during colonoscopy.
Measured: 3 months
Increase in Adenoma Detection Rate
The number of adenomas visualized during withdrawal of a colonoscope
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2017
- Study start1 Mar 2019
- Primary completion30 Jun 2023 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Colonic AdenomaStudies 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Trial
- Masking
- None (open label)
- Enrolment
- 172 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial University of Newfoundland
- Sponsor type
- University, hospital or other
- Collaborators
- Eastern Health
- Responsible party
- Principal investigator, Alison Greene, Memorial University of Newfoundland
- Investigators
- Alison M Greene, Medicine, Principal investigator, Memorial University of Newfoundland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03355495
- Sponsor's protocol ID
- 2017242
- Status last verified
- Apr 2022
- First submitted
- 20 Nov 2017
- Last updated
- 5 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Vergis N, McGrath AK, Stoddart CH, Hoare JM. Right Or Left in COLonoscopy (ROLCOL)? A Randomized Controlled Trial of Right- versus Left-Sided Starting Position in Colonoscopy. Am J Gastroenterol. 2015 Nov;110(11):1576-81. doi: 10.1038/ajg.2015.298. Epub 2015 Sep 29.
PubMed 26416195Ou 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 24629419Ball AJ, Johal SS, Riley SA. Position change during colonoscope withdrawal increases polyp and adenoma detection in the right but not in the left side of the colon: results of a randomized controlled trial. Gastrointest Endosc. 2015 Sep;82(3):488-94. doi: 10.1016/j.gie.2015.01.035. Epub 2015 Apr 22.
PubMed 25910661
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Comparing Right vs Left Lateral Decubitus Positioning on Outcomes in Colonoscopy
- ClinicalTrials.gov ID
- NCT03355495
- Acronym / sponsor ID
- 2017242
- Conditions
- Colonic Adenoma, Colonic Cancer
- Keywords
- Colonoscopy, Cecal Intubation Rate
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 172 participants (estimated)
- Lead sponsor
- Memorial University of NewfoundlandUniversity, hospital or other
- Collaborators
- Eastern Health
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 28 Nov 2017 (actual)
- 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.
Colonoscopy continues to be the gold standard in detecting precancerous lesions in the colon. It relies on adequate visualization of the bowel wall to see and remove such lesions. Visualization is improved with luminal distention, and a multitude of studies have been done to determine ways to increase this luminal distention. The investigators theorize that positioning in the Right Lateral Decubitus rather than the Left Lateral Decubitus may be a cost free method to increase luminal distention and, hence, improve visualization in colonoscopy. In the Right Lateral Decubitus position, the sigmoid colon and cecum - both parts of the bowel that are not fixed - air used during colonoscopy will rise in a dependent fashion, increasing luminal distention. In the left lateral decubitus position, the bowel collapses, creating an often difficult area to maneuver and visualize. The investigators would like to compare both positions to determine if it affects outcomes in colonoscopy. In particular, cecal intubation rates and adenoma detection rates.
Detailed description
Colonoscopy is considered the gold standard for detecting precancerous lesions in the bowel - providing both diagnostic and therapeutic value. Colonoscopy is, ultimately, operator dependent and relies on adequate visualization of these lesions. A multitude of studies have been done to determine the best way to achieve luminal distention that provides the best visualization to detect and remove adenomas. Recent literature has studied the effect of position changes in colonoscopy. Position changes have been theorized to increase luminal distention in the bowel - improving visualization and maneuverability through the colon. Both air and water are used during colonoscopy, with air rising in a dependent fashion in the colon to the highest point. The standard position to perform colonoscopy is left lateral decubitus. In this position, parts of the bowel collapse as air rises into other parts of the bowel. This includes the sigmoid colon and the cecum, both of which are not fixed and can therefore collapse becoming technically challenging to maneuver around. In the right lateral decubitus position, the air rises into these unfixed areas of bowel and are easier to maneuver. A trial by Vergis et al found that right lateral decubitus resulted in quicker examination times and more comfort in their cohort of patients as opposed to the left lateral decubitus position. The investigators note, however, that the population in which this study took place are not comparable to the patients in Newfoundland and in Canada. The investigators also note a study by Ou et al that found position changes had no effect in adenoma detection. Furthermore, a study by Ball et al found conflicting results with position change increased adenoma detection in the right but not the left side of the colon. Conflicting results between all these trials and the populations used have lead to us question if position changes, a cost free and technically easy intervention, can increase visualization in colonoscopy. The investigators propose a randomized controlled trial that compares positioning patients in the right lateral decubitus or left lateral decubitus to aid in luminal distention and visualization, decreasing cecal intubation time and ultimately increasing adenoma detection rate in colonoscopy.
In this trial, participation in the study will be offered when patients present for their scheduled colonoscopy. The patients will be consented at this time for both the colonoscopy procedure and participation in the trial. Patients who consent to take part will then be randomly assigned to either the right or left lateral decubitus starting position. The colonoscopy will then be done in the usual manner with appropriate sedation. Timing throughout the colonoscopy, the number of polyps found and quality of the visualization will then be recorded during the procedure. Patients will then be debriefed regarding their colonoscopy following the procedure in recovery.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Left Lateral Decubitus Position | No intervention | –Gold standard positioning for colonoscopy |
| Right Lateral Decubitus Position | Active comparator | Procedure: Colonoscopy - Position ChangeComparing positioning in Right Lateral Decubitus (intervention) for visualization in colonoscopy to the gold standard of Left Lateral Decubitus. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients 18 years of age or older presenting for their scheduled colonoscopy
Key exclusion criteria (4 listed)
- Previous bowel resection
- Unable to stay in either the right or left lateral decubitus position, due to pre-existing musculoskeletal problems, previous hip surgery, etc.
- Refusal to participate
- Inability to provide informed consent
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 - Position ChangeAlso: EndoscopyColonoscopy is the gold standard for detecting precancerous lesions. We are proposing that changing positions will provide better visualization for detecting such lesions. We will test our intervention of patients positioned in the Right Lateral Decubitus Position to the gold standard of Left Lateral Decubitus Positioning, hypothesizing better visualization in the right lateral decubitus position. | Procedure or surgery | Right Lateral Decubitus Position |
Primary outcome
Decrease in Cecal Intubation Time
Time frame: 3 months
The time it takes for a colonoscopist to start a colonoscopy and reach the cecum (endpoint or target area)
2 secondary outcomes
Increase in Cecal Intubation Rate
Time frame: 3 months
Increase in Adenoma Detection Rate
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2022.
- Results publication: PubMed 26416195Vergis N, McGrath AK, Stoddart CH, Hoare JM. Right Or Left in COLonoscopy (ROLCOL)? A Randomized Controlled Trial of Right- versus Left-Sided Starting Position in Colonoscopy. Am J Gastroenterol. 2015 Nov;110(11):1576-81. doi: 10.1038/ajg.2015.298. Epub 2015 Sep 29.
- Results publication: 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.
- Results publication: PubMed 25910661Ball AJ, Johal SS, Riley SA. Position change during colonoscope withdrawal increases polyp and adenoma detection in the right but not in the left side of the colon: results of a randomized controlled trial. Gastrointest Endosc. 2015 Sep;82(3):488-94. doi: 10.1016/j.gie.2015.01.035. Epub 2015 Apr 22.
- Individual participant dataSharing planned: No
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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.
Alison M Greene, Medicine principal investigator
Memorial University of Newfoundland
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 - Position Change in people with Colonic Adenoma and Colonic Cancer, run by Memorial University of Newfoundland 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 1 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 5 Apr 2022. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alison M Greene, Medicine (709 693 7334, amgreene@mun.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decrease in Cecal Intubation Time (time frame: 3 months). 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 NCT03355495, which also lists 3 linked publications.
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 5 Apr 2022.