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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 : February 20, 2020
Sponsor:
Collaborator:
Eastern Health
Information provided by (Responsible Party):
Alison Greene, Memorial University of Newfoundland

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Colonic Adenoma Colonic Cancer Procedure: Colonoscopy - Position Change Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 172 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized Controlled Trial
Masking: None (Open Label)
Primary Purpose: Screening
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 : June 30, 2020
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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.

  2. Increase in Adenoma Detection Rate [ Time Frame: 3 months ]
    The number of adenomas visualized during withdrawal of a colonoscope



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients 18 years of age or older presenting for their scheduled colonoscopy

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

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


Contacts
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Contact: Alison M Greene, Medicine 709 693 7334 amgreene@mun.ca

Locations
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Canada, Newfoundland and Labrador
Health Sciences Centre Recruiting
Saint John's, Newfoundland and Labrador, Canada, A1B3V6
Contact: Alison M Greene, MD    7096937334      
Contact    7096937334      
Sponsors and Collaborators
Memorial University of Newfoundland
Eastern Health
Investigators
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Principal Investigator: Alison M Greene, Medicine Memorial University of Newfoundland

Publications of Results:
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Responsible Party: Alison Greene, Principal Investigator, Memorial University of Newfoundland
ClinicalTrials.gov Identifier: NCT03355495    
Other Study ID Numbers: 2017242
First Posted: November 28, 2017    Key Record Dates
Last Update Posted: February 20, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Alison Greene, Memorial University of Newfoundland:
Colonoscopy
Cecal Intubation Rate
Additional relevant MeSH terms:
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Adenoma
Colonic Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases