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

Primary Purpose

Colonoscopy

Status
Unknown status
Phase
Not Applicable
Locations
Colombia
Study Type
Interventional
Intervention
Left Sided Colonoscopy
Right Sided Colonoscopy
Sponsored by
Sanitas University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Colonoscopy focused on measuring Colonoscopy

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Clinica Universitaria ColombiaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Left Sided Colonoscopy

Right sided Colonoscopy

Arm Description

Left Sided starting position in colonoscopy

Right Sided starting position in colonoscopy

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Number of polyps
Number of polyps detected in procedure
Number of diverticula
Number of diverticula detected in 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
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
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
Change position needed
Necessity of changing starting position of the patient during procedure
Abdominal pressure needed
Necessity of maneuvers to increasing abdominal pressure during procedure
Major adverse event
Transient or Prolonged hypoxemia, Arrhythmias, Hypotension, Perforation.

Full Information

First Posted
December 3, 2020
Last Updated
December 21, 2020
Sponsor
Sanitas University
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1. Study Identification

Unique Protocol Identification Number
NCT04663581
Brief Title
Comparison Between the Right Lateral Decubitus and the Left Lateral Decubitus as Starting Position in Colonoscopy
Acronym
POSCOL
Official Title
Comparison Between the Right Lateral Decubitus and the Left Lateral Decubitus as Starting Position in Colonoscopy. Randomized Clinical Trial (POSCOL)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Unknown status
Study Start Date
December 6, 2020 (Actual)
Primary Completion Date
February 28, 2021 (Anticipated)
Study Completion Date
March 15, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sanitas University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colonoscopy
Keywords
Colonoscopy

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
167 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Left Sided Colonoscopy
Arm Type
Experimental
Arm Description
Left Sided starting position in colonoscopy
Arm Title
Right sided Colonoscopy
Arm Type
Active Comparator
Arm Description
Right Sided starting position in colonoscopy
Intervention Type
Other
Intervention Name(s)
Left Sided Colonoscopy
Intervention Description
Starting colonoscopy with the patient in left decubitus
Intervention Type
Other
Intervention Name(s)
Right Sided Colonoscopy
Intervention Description
Starting colonoscopy with the patient in right decubitus
Primary Outcome Measure Information:
Title
Time to Reach Transverse Colon
Description
Time from starting of colonoscopy until endoscopist reaches transverse colon
Time Frame
During Procedure
Title
Time to Reach Cecum
Description
Time from starting of colonoscopy until endoscopist reaches cecum
Time Frame
During Procedure
Secondary Outcome Measure Information:
Title
Number of polyps
Description
Number of polyps detected in procedure
Time Frame
During Procedure
Title
Number of diverticula
Description
Number of diverticula detected in procedure
Time Frame
During Procedure
Title
Cecal Intubation
Description
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
Time Frame
During Procedure
Title
Endoscopist Comfort
Description
Comfort of the endoscopist measure in a 0 to 10 scale, being 0 not difficulty experienced, and 10 impossibility to intubate the appendix
Time Frame
During Procedure
Title
Patient Comfort
Description
Comfort of the patient measure in a 0 to 10 scale, being 0 not discomfort experienced, and 10 unbearable discomfort experienced during procedure
Time Frame
During Procedure
Title
Change position needed
Description
Necessity of changing starting position of the patient during procedure
Time Frame
During Procedure
Title
Abdominal pressure needed
Description
Necessity of maneuvers to increasing abdominal pressure during procedure
Time Frame
During Procedure
Title
Major adverse event
Description
Transient or Prolonged hypoxemia, Arrhythmias, Hypotension, Perforation.
Time Frame
During Procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jorge A Medina, MD
Phone
011 57 3165317902
Email
jamedinap@unal.edu.co
First Name & Middle Initial & Last Name or Official Title & Degree
Diego M Aponte, MD MSc
Phone
011 57 3108527122
Email
didimauro673@yahoo.es
Facility Information:
Facility Name
Clinica Universitaria Colombia
City
Bogota
ZIP/Postal Code
111321
Country
Colombia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jorge A Medina, MD
Phone
3165317902
Email
jamedinap@unal.edu.co
First Name & Middle Initial & Last Name & Degree
Diego Aponte, MD
Phone
310852712
Email
didimauro673@yahoo.es

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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