R vs L Lateral Decubitus Positioning in Colonoscopy
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|ClinicalTrials.gov Identifier: NCT03355495|
Recruitment Status : Recruiting
First Posted : November 28, 2017
Last Update Posted : March 6, 2019
|Condition or disease||Intervention/treatment||Phase|
|Colonic Adenoma Colonic Cancer||Procedure: Colonoscopy - Position Change||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||172 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Randomized Controlled Trial|
|Masking:||None (Open Label)|
|Official Title:||A Randomized Controlled Trial Comparing Right vs Left Lateral Decubitus Positioning on Outcomes in Colonoscopy|
|Actual Study Start Date :||March 1, 2019|
|Estimated Primary Completion Date :||September 30, 2019|
|Estimated Study Completion Date :||September 30, 2019|
No Intervention: Left Lateral Decubitus Position
Gold standard positioning for colonoscopy
Active Comparator: Right Lateral Decubitus Position
Comparing positioning in Right Lateral Decubitus (intervention) for visualization in colonoscopy to the gold standard of Left Lateral Decubitus.
Procedure: Colonoscopy - Position Change
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.
Other Name: Endoscopy
- 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)
- Increase in Cecal Intubation Rate [ Time Frame: 3 months ]An important indicator in colonoscopy quality, the percentage of times a colonoscopist can reach the cecum during colonoscopy.
- Increase in Adenoma Detection Rate [ Time Frame: 3 months ]The number of adenomas visualized during withdrawal of a colonoscope
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03355495
|Contact: Alison M Greene, Medicine||709 693 firstname.lastname@example.org|
|Canada, Newfoundland and Labrador|
|Health Sciences Centre||Recruiting|
|Saint John's, Newfoundland and Labrador, Canada, A1B3V6|
|Contact: Alison M Greene, MD 7096937334|
|Principal Investigator:||Alison M Greene, Medicine||Memorial University of Newfoundland|