ColonoscopyPOSCOLNCT04663581
Comparison Between the Right Lateral Decubitus and the Left Lateral Decubitus as Starting Position in Colonoscopy
A study testing Left Sided Colonoscopy and Right Sided Colonoscopy in people with Colonoscopy, run by Sanitas University at 1 site in Colombia.
Trial summary
Randomized Clinical trial between two positions to initiate colonoscopy, Right Sided vs Left Sided Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Colonoscopy
- What is being tested?
- Left Sided Colonoscopy and Right Sided Colonoscopy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 167 participants
- Where
- 1 siteColombia
- Study dates
- 6 Dec 2020to 15 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled for diagnostic colonoscopies in the digestive endoscopy unit.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Colombia1 site, 1 recruiting
- Recruiting
Clinica Universitaria Colombia
Bogotá, 111321
Jorge A Medina, MD, 3165317902, jamedinap@unal.edu.co
Diego Aponte, MD, 310852712, didimauro673@yahoo.es
About this study
Official title: 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
Read the 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.
- Conditions
- Colonoscopy
- Being tested
- Left Sided Colonoscopy, Right Sided Colonoscopy
- Keywords
- Colonoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Left Sided ColonoscopyOther
Starting colonoscopy with the patient in left decubitus
Right Sided ColonoscopyOther
Starting colonoscopy with the patient in right decubitus
| Study group | Role | What they receive |
|---|---|---|
| Left Sided Colonoscopy | Experimental | Left Sided starting position in colonoscopy Receives: Other: Left Sided Colonoscopy |
| Right sided Colonoscopy | Active comparator | Right Sided starting position in colonoscopy Receives: Other: Right Sided Colonoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Reach Transverse Colon
Time from starting of colonoscopy until endoscopist reaches transverse colon
Measured: During Procedure
Time to Reach Cecum
Time from starting of colonoscopy until endoscopist reaches cecum
Measured: During Procedure
Secondary outcomes (8)
Number of polyps
Number of polyps detected in procedure
Measured: During Procedure
Number of diverticula
Number of diverticula detected in procedure
Measured: 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
Measured: 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
Measured: 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
Measured: During Procedure
Change position needed
Necessity of changing starting position of the patient during procedure
Measured: During Procedure
Abdominal pressure needed
Necessity of maneuvers to increasing abdominal pressure during procedure
Measured: During Procedure
Major adverse event
Transient or Prolonged hypoxemia, Arrhythmias, Hypotension, Perforation.
Measured: During Procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2020
- Study start6 Dec 2020
- Primary completion28 Feb 2021 (estimated)
- Study completion15 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ColonoscopyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 167 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sanitas University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Claudia Aristizábal, Sanitas University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04663581
- Sponsor's protocol ID
- CEIFUS 597-19
- Acronym
- POSCOL
- Status last verified
- Dec 2020
- First submitted
- 3 Dec 2020
- Last updated
- 23 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between the Right Lateral Decubitus and the Left Lateral Decubitus as Starting Position in Colonoscopy. Randomized Clinical Trial (POSCOL)
- ClinicalTrials.gov ID
- NCT04663581
- Acronym / sponsor ID
- POSCOL / CEIFUS 597-19
- Conditions
- Colonoscopy
- Keywords
- Colonoscopy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 167 participants (estimated)
- Lead sponsor
- Sanitas UniversityUniversity, hospital or other
- Study start
- 6 Dec 2020 (actual)
- Primary completion
- 28 Feb 2021 (estimated)
- Study completion
- 15 Mar 2021 (estimated)
- First posted
- 11 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Left Sided Colonoscopy | Experimental | Other: Left Sided ColonoscopyLeft Sided starting position in colonoscopy |
| Right sided Colonoscopy | Active comparator | Other: Right Sided ColonoscopyRight Sided starting position in colonoscopy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients scheduled for diagnostic colonoscopies in the digestive endoscopy unit.
Key exclusion criteria (6 listed)
- Therapeutic colonoscopies.
- Patients with a history of colonic resection.
- Patients who cannot give their informed consent.
- Under 18 years old.
- Pregnant women.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Left Sided ColonoscopyStarting colonoscopy with the patient in left decubitus | Other | Left Sided Colonoscopy |
| Right Sided ColonoscopyStarting colonoscopy with the patient in right decubitus | Other | Right sided Colonoscopy |
Primary outcome
Time to Reach Transverse Colon
Time frame: During Procedure
Time from starting of colonoscopy until endoscopist reaches transverse colon
Time to Reach Cecum
Time frame: During Procedure
Time from starting of colonoscopy until endoscopist reaches cecum
8 secondary outcomes
Number of polyps
Time frame: During Procedure
Number of diverticula
Time frame: During Procedure
Cecal Intubation
Time frame: During Procedure
Endoscopist Comfort
Time frame: During Procedure
Patient Comfort
Time frame: During Procedure
Change position needed
Time frame: During Procedure
Abdominal pressure needed
Time frame: During Procedure
Major adverse event
Time frame: During Procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Left Sided Colonoscopy and Right Sided Colonoscopy in people with Colonoscopy, run by Sanitas University at 1 site in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jorge A Medina, MD (011 57 3165317902, jamedinap@unal.edu.co), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Reach Transverse Colon (time frame: During Procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2020.