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

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

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

Study Overview

• Status: Unknown
• Conditions: Colonoscopy
• Intervention / Treatment: Other: Left Sided Colonoscopy; Other: Right Sided Colonoscopy

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 Type: Interventional
• Enrollment (Anticipated): 167
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Colombia
  • Bogota, Colombia, 111321
    • Recruiting
    • Clínica Universitaria Colombia
    • Contact: Jorge A Medina, MD; Phone Number: 3165317902; Email: jamedinap@unal.edu.co
    • Contact: Diego Aponte, MD; Phone Number: 310852712; Email: didimauro673@yahoo.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: SCREENING
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Left Sided Colonoscopy; Left Sided starting position in colonoscopy	Other: Left Sided Colonoscopy; Starting colonoscopy with the patient in left decubitus
ACTIVE_COMPARATOR: Right sided Colonoscopy; Right Sided starting position in colonoscopy	Other: Right Sided Colonoscopy; Starting colonoscopy with the patient in right decubitus

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Sanitas University

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 6, 2020
• Primary Completion (ANTICIPATED): February 28, 2021
• Study Completion (ANTICIPATED): March 15, 2021

Study Registration Dates

• First Submitted: December 3, 2020
• First Submitted That Met QC Criteria: December 4, 2020
• First Posted (ACTUAL): December 11, 2020

Study Record Updates

• Last Update Posted (ACTUAL): December 23, 2020
• Last Update Submitted That Met QC Criteria: December 21, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: Colonoscopy
• Additional Relevant MeSH Terms: Skin Diseases; Skin Ulcer; Pressure Ulcer
• Other Study ID Numbers: CEIFUS 597-19

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No