Comparison Between the Right Lateral Decubitus and the Left Lateral Decubitus as Starting Position in Colonoscopy

Colonoscopy Clinical Trial

— POSCOL  

Official title:

Comparison Between the Right Lateral Decubitus and the Left Lateral Decubitus as Starting Position in Colonoscopy. Randomized Clinical Trial (POSCOL)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04663581
• Other study ID #: CEIFUS 597-19
• Status: Recruiting
• Phase: N/A
• Start date: December 6, 2020
• Est. completion date: March 15, 2021

Study information

• Verified date: December 2020
• Source: Sanitas University
• Contact: Jorge A Medina, MD
• Phone: 011 57 3165317902
• Email: jamedinap[@]unal.edu.co
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Randomized Clinical trial between two positions to initiate colonoscopy, Right Sided vs Left Sided

Description:

Objective To assess whether in the colonoscopy, the initial position of the patient in the right lateral decubitus (DLD) translates into advantages such as: shorter examination time or greater range of detection of polyps, compared to the left lateral decubitus (DLI), a position traditionally used.

Methodology This is a randomized and controlled clinical trial to be carried out in the city of Bogotá, in the Gastroenterology and Digestive Endoscopy Unit of the Colombia University Clinic, a fourth-level private clinic, a unit in which 7746 colonoscopies were performed in 2017.

The study will be carried out over a period of 2 months until the sample is completed.

Patients will be randomized to start their colonoscopy in the right lateral decubitus or left lateral decubitus and it would be assessed, the time to reach transverse colon, cecum and comfort perceived by the gastroenterologist and the patient.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 167
• Est. completion date: March 15, 2021
• Est. primary completion date: February 28, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Patients scheduled for diagnostic colonoscopies in the digestive endoscopy unit.

Exclusion Criteria:

• Therapeutic colonoscopies.

• Patients with a history of colonic resection.

• Patients who cannot give their informed consent.

• Under 18 years old.

• Pregnant women.

• Patients with significant cardiopulmonary, renal or psychiatric disease.

Related Conditions & MeSH terms

• Colonoscopy
• Pressure Ulcer

Intervention

Other:
• Left Sided Colonoscopy
Starting colonoscopy with the patient in left decubitus
• Right Sided Colonoscopy
Starting colonoscopy with the patient in right decubitus

Locations

Country	Name	City	State
Colombia	Clinica Universitaria Colombia	Bogota

Sponsors (1)

Lead Sponsor	Collaborator
Sanitas University

Country where clinical trial is conducted

Colombia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to Reach Transverse Colon	Time from starting of colonoscopy until endoscopist reaches transverse colon	During Procedure
Primary	Time to Reach Cecum	Time from starting of colonoscopy until endoscopist reaches cecum	During Procedure
Secondary	Number of polyps	Number of polyps detected in procedure	During Procedure
Secondary	Number of diverticula	Number of diverticula detected in procedure	During Procedure
Secondary	Cecal Intubation	Passage of the colonoscope tip to a point proximal to the ileocecal valve, so that the entire cecal caput, including the medial wall of the cecum between the ileocecal valve and appendiceal orifice, is visible	During Procedure
Secondary	Endoscopist Comfort	Comfort of the endoscopist measure in a 0 to 10 scale, being 0 not difficulty experienced, and 10 impossibility to intubate the appendix	During Procedure
Secondary	Patient Comfort	Comfort of the patient measure in a 0 to 10 scale, being 0 not discomfort experienced, and 10 unbearable discomfort experienced during procedure	During Procedure
Secondary	Change position needed	Necessity of changing starting position of the patient during procedure	During Procedure
Secondary	Abdominal pressure needed	Necessity of maneuvers to increasing abdominal pressure during procedure	During Procedure
Secondary	Major adverse event	Transient or Prolonged hypoxemia, Arrhythmias, Hypotension, Perforation.	During Procedure