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

NCT ID: NCT04663581

Last Updated: 2020-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

167 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-06

Study Completion Date

2021-03-15

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.

Conditions

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Colonoscopy

Keywords

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Colonoscopy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Left Sided Colonoscopy

Left Sided starting position in colonoscopy

Group Type EXPERIMENTAL

Left Sided Colonoscopy

Intervention Type OTHER

Starting colonoscopy with the patient in left decubitus

Right sided Colonoscopy

Right Sided starting position in colonoscopy

Group Type ACTIVE_COMPARATOR

Right Sided Colonoscopy

Intervention Type OTHER

Starting colonoscopy with the patient in right decubitus

Interventions

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Left Sided Colonoscopy

Starting colonoscopy with the patient in left decubitus

Intervention Type OTHER

Right Sided Colonoscopy

Starting colonoscopy with the patient in right decubitus

Intervention Type OTHER

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sanitas University

OTHER

Sponsor Role lead

Responsible Party

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Claudia Aristizábal

Chief of Clinical Research Office

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Clinica Universitaria Colombia

Bogotá, , Colombia

Site Status RECRUITING

Countries

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Colombia

Central Contacts

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Jorge A Medina, MD

Role: CONTACT

Phone: 011 57 3165317902

Email: [email protected]

Diego M Aponte, MD MSc

Role: CONTACT

Phone: 011 57 3108527122

Email: [email protected]

Facility Contacts

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Jorge A Medina, MD

Role: primary

Diego Aponte, MD

Role: backup

Other Identifiers

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CEIFUS 597-19

Identifier Type: -

Identifier Source: org_study_id