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R vs L Lateral Decubitus Positioning in Colonoscopy

Primary Purpose

Colonic Adenoma, Colonic Cancer

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Colonoscopy - Position Change
Sponsored by
Memorial University of Newfoundland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Colonic Adenoma focused on measuring Colonoscopy, Cecal Intubation Rate

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Health Sciences CentreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Left Lateral Decubitus Position

Right Lateral Decubitus Position

Arm Description

Gold standard positioning for colonoscopy

Comparing positioning in Right Lateral Decubitus (intervention) for visualization in colonoscopy to the gold standard of Left Lateral Decubitus.

Outcomes

Primary Outcome Measures

Decrease in Cecal Intubation Time
The time it takes for a colonoscopist to start a colonoscopy and reach the cecum (endpoint or target area)

Secondary Outcome Measures

Increase in Cecal Intubation Rate
An important indicator in colonoscopy quality, the percentage of times a colonoscopist can reach the cecum during colonoscopy.
Increase in Adenoma Detection Rate
The number of adenomas visualized during withdrawal of a colonoscope

Full Information

First Posted
November 20, 2017
Last Updated
April 4, 2022
Sponsor
Memorial University of Newfoundland
Collaborators
Eastern Health
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1. Study Identification

Unique Protocol Identification Number
NCT03355495
Brief Title
R vs L Lateral Decubitus Positioning in Colonoscopy
Official Title
A Randomized Controlled Trial Comparing Right vs Left Lateral Decubitus Positioning on Outcomes in Colonoscopy
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2019 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
June 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Memorial University of Newfoundland
Collaborators
Eastern Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colonic Adenoma, Colonic Cancer
Keywords
Colonoscopy, Cecal Intubation Rate

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized Controlled Trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
172 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Left Lateral Decubitus Position
Arm Type
No Intervention
Arm Description
Gold standard positioning for colonoscopy
Arm Title
Right Lateral Decubitus Position
Arm Type
Active Comparator
Arm Description
Comparing positioning in Right Lateral Decubitus (intervention) for visualization in colonoscopy to the gold standard of Left Lateral Decubitus.
Intervention Type
Procedure
Intervention Name(s)
Colonoscopy - Position Change
Other Intervention Name(s)
Endoscopy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Decrease in Cecal Intubation Time
Description
The time it takes for a colonoscopist to start a colonoscopy and reach the cecum (endpoint or target area)
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Increase in Cecal Intubation Rate
Description
An important indicator in colonoscopy quality, the percentage of times a colonoscopist can reach the cecum during colonoscopy.
Time Frame
3 months
Title
Increase in Adenoma Detection Rate
Description
The number of adenomas visualized during withdrawal of a colonoscope
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alison M Greene, Medicine
Phone
709 693 7334
Email
amgreene@mun.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alison M Greene, Medicine
Organizational Affiliation
Memorial University of Newfoundland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Health Sciences Centre
City
Saint John's
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1B3V6
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alison M Greene, MD
Phone
7096937334
Phone
7096937334

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26416195
Citation
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.
Results Reference
result
PubMed Identifier
24629419
Citation
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.
Results Reference
result
PubMed Identifier
25910661
Citation
Ball 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.
Results Reference
result

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R vs L Lateral Decubitus Positioning in Colonoscopy

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