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

Not Applicable

• Conditions: Colonoscopy
• Interventions: Other: Left Sided Colonoscopy; Other: Right Sided Colonoscopy

• Registration Number: NCT04663581
• Lead Sponsor: Sanitas University

Brief Summary

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

Detailed 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.

Study Timeline

• Status Verified: 2020-12
• Study First Submitted: 2020-12-03
• Study First Submitted QC: 2020-12-04
• Study Start: 2020-12-06
• Study First Posted: 2020-12-11
• Last Update Submitted: 2020-12-21
• Last Update Posted: 2020-12-23
• Primary Completion: 2021-02-28
• Study Completion: 2021-03-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 167

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Left Sided Colonoscopy	Left Sided Colonoscopy	Left Sided starting position in colonoscopy
Right sided Colonoscopy	Right Sided Colonoscopy	Right Sided starting position in colonoscopy

Primary Outcome Measures

Name	Time	Method
Time to Reach Cecum	During Procedure	Time from starting of colonoscopy until endoscopist reaches cecum
Time to Reach Transverse Colon	During Procedure	Time from starting of colonoscopy until endoscopist reaches transverse colon

Secondary Outcome Measures

Name	Time	Method
Number of diverticula	During Procedure	Number of diverticula detected in procedure
Patient Comfort	During Procedure	Comfort of the patient measure in a 0 to 10 scale, being 0 not discomfort experienced, and 10 unbearable discomfort experienced during procedure
Cecal Intubation	During Procedure	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
Endoscopist Comfort	During Procedure	Comfort of the endoscopist measure in a 0 to 10 scale, being 0 not difficulty experienced, and 10 impossibility to intubate the appendix
Change position needed	During Procedure	Necessity of changing starting position of the patient during procedure
Abdominal pressure needed	During Procedure	Necessity of maneuvers to increasing abdominal pressure during procedure
Number of polyps	During Procedure	Number of polyps detected in procedure
Major adverse event	During Procedure	Transient or Prolonged hypoxemia, Arrhythmias, Hypotension, Perforation.

Trial Locations

Locations (1)

Clinica Universitaria Colombia; 🇨🇴 Bogota, Colombia