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

Study Overview
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Brief Summary
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Randomized Clinical trial between two positions to initiate colonoscopy, Right Sided vs Left Sided

Detailed Description
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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.

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

Conditions
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Colonoscopy

Intervention / Treatment
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* Other: Left Sided Colonoscopy
* Other: Right Sided Colonoscopy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Left Sided Colonoscopy<br>Left Sided starting position in colonoscopy | Other: Left Sided Colonoscopy<br>* Starting colonoscopy with the patient in left decubitus<br>|
| Active Comparator: Right sided Colonoscopy<br>Right Sided starting position in colonoscopy | Other: Right Sided Colonoscopy<br>* Starting colonoscopy with the patient in right decubitus<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Reach Transverse Colon | Time from starting of colonoscopy until endoscopist reaches transverse colon | During Procedure | 
| Time to Reach Cecum | Time from starting of colonoscopy until endoscopist reaches cecum | During Procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of polyps | Number of polyps detected in procedure | During Procedure | 
| Number of diverticula | Number of diverticula detected in procedure | During Procedure | 
| 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 | 
| 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 | 
| 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 | 
| Change position needed | Necessity of changing starting position of the patient during procedure | During Procedure | 
| Abdominal pressure needed | Necessity of maneuvers to increasing abdominal pressure during procedure | During Procedure | 
| Major adverse event | Transient or Prolonged hypoxemia, Arrhythmias, Hypotension, Perforation. | During Procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Colonoscopy