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Inception, Validation and Clinical Utility of a Score to Assess the Completeness of Caecal Visualisation

Sponsor
University Hospital, Ghent (Other)
Overall Status
Completed
CT.gov ID
NCT05854277
Collaborator
(none)
79
Enrollment
1
Location
1
Arm
27
Actual Duration (Days)
89.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

CCIS is a novel score, created specifically to evaluate the completeness of caecal visualized. It can be applied to a single or multiple images. To create the CCIS, the caecum was divided into eight parts: the appendiceal orifice (AO), the tri-radiate fold part 1 (TF-1), 2 (TF-2), 3 (TF-3) and four outer quadrants (OQ 1-4). The ileo-caecal valve (ICV) is a reference point but is not part of the score. The quadrant adjacent to the ICV is labelled OQ1. The three other quadrants are labelled clockwise from this quadrant. The tri-radiate folds are also labelled clockwise with TF1 representing the triangle side that is majority-contained within OQ1. TF2 and TF3 are then labelled clockwise from TF1.

Condition or Disease Intervention/Treatment Phase
  • Other: educational video
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
79 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Screening
Official Title:
Inception, Validation and Clinical Utility of a Score to Assess the Completeness of Caecal Visualisation.
Actual Study Start Date :
Feb 1, 2021
Actual Primary Completion Date :
Feb 15, 2021
Actual Study Completion Date :
Feb 28, 2021

Arms and Interventions

Arm Intervention/Treatment
Other: Endoscopists

Other: educational video
To explain the novel score, a six-minute instructional video was compiled and available to watch, as well as an online tool on the GIEQs website that could be used to grade the image-sets using the score.

Outcome Measures

Primary Outcome Measures

  1. VALIDATE A NOVEL SCORE FOR THE COMPLETENESS OF CAECAL INTUBATION [4 weeks]

    To create the CCIS, the caecum is divided into eight parts: the appendiceal orifice (AO), the tri-radiate fold part 1 (TF-1), 2 (TF-2), 3 (TF-3) and four outer quadrants (OQ 1-4). The ileo-cacecal valve (ICV) is a reference point but is not part of the score. The quadrant adjacent to the valve is labelled OQ1. The three other quadrants are labelled clockwise from this quadrant. For every component of the CCIS that is completely visualized on the image, one point is gained with a maximum possible CCIS of 8 and a minimum of 0. Participants were asked to answer the same six questions for each image-set. Is this an image of the caecum? What is the Boston Bowel Preparation score for this segment of the colon? What is your subjective first impression (yes/no) regarding completeness of caecal intubation? What subjective percentage do you believe was assessed? What is the CCIS score for this image-set? Using the online tool, which components of the CCIS were seen

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Endoscopists >18 years old
Exclusion Criteria:

  • Endoscopist not signing informed consent

  • Any other medical doctor not connected with endoscopic practice

Contacts and Locations

Locations

Site City State Country Postal Code
1 UZ Gent Ghent Belgium 9000

Sponsors and Collaborators

  • University Hospital, Ghent

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT05854277
Other Study ID Numbers:
  • BC-09013
First Posted:
May 11, 2023
Last Update Posted:
May 11, 2023
Last Verified:
May 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Colonic Polyps

Study Results

No Results Posted as of May 11, 2023