NCT04663581

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
167

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 3, 2020

Completed
3 days until next milestone

Study Start

First participant enrolled

December 6, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 11, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2021

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2021

Completed
Last Updated

December 23, 2020

Status Verified

December 1, 2020

Enrollment Period

3 months

First QC Date

December 3, 2020

Last Update Submit

December 21, 2020

Conditions

Colonoscopy

Keywords

Colonoscopy

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (8)

  • Number of polyps

    During Procedure

  • Number of diverticula

    During Procedure

  • Cecal Intubation

    During Procedure

  • Endoscopist Comfort

    During Procedure

  • Patient Comfort

    During Procedure

  • +3 more secondary outcomes

Study Arms (2)

Left Sided Colonoscopy

EXPERIMENTAL

Left Sided starting position in colonoscopy

Other: Left Sided Colonoscopy

Right sided Colonoscopy

ACTIVE COMPARATOR

Right Sided starting position in colonoscopy

Other: Right Sided Colonoscopy

Interventions

Left Sided ColonoscopyOTHER

Starting colonoscopy with the patient in left decubitus

Left Sided Colonoscopy
Right Sided ColonoscopyOTHER

Starting colonoscopy with the patient in right decubitus

Right sided Colonoscopy

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients scheduled for diagnostic colonoscopies in the digestive endoscopy unit.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinica Universitaria Colombia

Bogotá, 111321, Colombia

RECRUITING

Central Study Contacts

Jorge A Medina, MD

CONTACT

011 57 3165317902jamedinap@unal.edu.co

Diego M Aponte, MD MSc

CONTACT

011 57 3108527122didimauro673@yahoo.es

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief of Clinical Research Office

Study Record Dates

First Submitted

December 3, 2020

First Posted

December 11, 2020

Study Start

December 6, 2020

Primary Completion

February 28, 2021

Study Completion

March 15, 2021

Last Updated

December 23, 2020

Record last verified: 2020-12

Locations

CO(1)