R vs L Lateral Decubitus Positioning in Colonoscopy

NCT03355495 | Unknown

• 1 other identifier: 2017242
• Study Type: interventional
• Target: 172
• Locations: 1 country
• Sites: 1

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.

Conditions

Colonic Adenoma; Colonic Cancer

Keywords

Colonoscopy; Cecal Intubation Rate

Outcome Measures

Primary Outcomes (1)

• Decrease in Cecal Intubation Time

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

  3 months

Secondary Outcomes (2)

• Increase in Cecal Intubation Rate

  3 months

• Increase in Adenoma Detection Rate

  3 months

Study Arms (2)

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.

Procedure: Colonoscopy - Position Change

Interventions

Colonoscopy - Position Change PROCEDURE

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.

Also known as: Endoscopy

Right Lateral Decubitus Position

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Memorial University of Newfoundland: lead
• Eastern Health: collaborator

Study Sites (1)

Health Sciences Centre

St. John's, Newfoundland and Labrador, A1B3V6, Canada

RECRUITING

Related Publications (3)

• 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.

  PMID: 26416195 RESULT

• 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.

  PMID: 24629419 RESULT

• 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.

  PMID: 25910661 RESULT

MeSH Terms

Conditions

Colonic Neoplasms

Interventions

Endoscopy

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Alison M Greene, Medicine

  Memorial University of Newfoundland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alison M Greene, Medicine

CONTACT

709 693 7334; amgreene@mun.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized Controlled Trial

Study Record Dates

• First Submitted: November 20, 2017
• First Posted: November 28, 2017
• Study Start: March 1, 2019
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: April 5, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)