The Colon Endoscopic Bubble Scale (CEBuS); Validation Study (CEBuS)

May 13, 2020 updated by: Filipe Taveira, Portuguese Oncology Institute, Coimbra

Colonoscopy is currently accepted as the gold standard in screening, surveillance and prevention for colorectal cancer (CRC), and therefore, its quality is a major priority.

The quality of colonoscopy is greatly dependent on the quality of the bowel preparation, which can be limited by stool, foam, bubbles and other debris. In fact, colonic bubbles are described in 30 to 40% of colonoscopies, possibly undermining the quality of the exam, impairing the endoscopists view, demanding the further use of water or simethicone and eventually increasing fatigue and costs, while diminishing diagnostic accuracy.

Although previous attempts, to date no endoscopic scale is validated regarding the presence of bubbles and most widely accepted and already validated scales do not include the presence or absence of bubbles in their definition, leading to the use of different home-made scales in randomized trials and impairing any solid meta-analysis conclusion. As so, the goal of this study is to develop and validate a new colonic bubble score (Colon Endoscopic Bubble Scale - CEBuS).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Colonoscopy bowel preparation quality is a major concern since inadequate bowel preparation can reach levels as high as 30% which lead to several guidelines in this area, with the recent recommendation of at least 90% of good bowel preparations for all colonoscopies. In fact colonic mucosal visualization can be limited by residual stool, bubbles, bile and other debris increasing the risk of missing lesions.

Around 30 to 40% of the exams can have bubbles increasing the risk of missing lesions and in the other hand increasing the time of the exam, generating more fatigue in the endoscopist and increasing the costs.

The influence of colon bubbles in bowel preparation and strategies to solve them, for example with the use of simethicone in the bowel preparation, were addresses in recent studies, summarized in a 2018 meta-analysis recommending the use of simethicone in the bowel preparation scheme.

Current recommendations advise the use of validated scales to evaluate bowel preparation quality, but the three major validated scales, Boston, Ottawa and Aronchick, does not address the problem of graduation of colonic bubbles and possible actions to undertake regarding the severity of the bubbles concentration. The advent of multiple randomized trials addressing the use of simethicone in the bowel preparation to reduce or eliminate bubble formation lead to attempts to design scales to graduate the concentration of bubbles in the colon.

To date suggested scales are heterogeneous regarding the graduation (3 to 4 levels), defining criteria for each level with some based on percentage of colonic circumference obscured by bubbles to the amount of bubbles that could lead to miss a polyp of 5 or 10 millimetres.Two recently published studies on the influence of simethicone on bowel preparation tried to validate a colonic bubble scale, based on previous suggested and non-validated scales, although with only fair to moderate inter-observer variability.

Therefore, the main goal of this project is to build and validate a comprehensive scale to graduate bubbles in the colon, assessing the inter- and intra-observer reliability of the scale. As a secondary objective, to determine the clinical attitude more frequent for each grade of the bubbles scale, among experts and residents.

Aims: Build and validate a new colonic bubble score (Colon Endoscopic Bubble Scale - CEBuS).

Study Type

Observational

Enrollment (Actual)

24

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Portugal
      • Coimbra, Portugal, 3001 - 651
        • Portuguese Oncology Institute - Coimbra

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Were selected for the study 23 observers - 10 experts and 13 in-training/young specialists endoscopists from six European countries (Portugal, France, Italy, Romania, Poland and Slovakia).

Description

Inclusion Criteria:

  • For the expert group: at least 15 years of regular practice in colonoscopy
  • For the trainee group: 5 years or less in the practice of colonoscopy

Exclusion Criteria:

  • Non endoscopist and if out of the experience standards required.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group 1 - experts

Evaluation of 15 images for each of the proposed 3 grade scale (45 images in total), randomly distributed to validate de scale; images will be assessed twice by the participants with a two-week interval in both study phases (the random distribution will vary between both evaluations).

Together with the assessment of each image the participant is invited to choose one of possible three clinical actions (do nothing, wash with water and wash with simethicone)
Other: Validation of CEBuS
Validation of a new score for bubbles in the colon.
Group 2 - mix experts/trainee

If intra and interobserver rates in group 1 are >0.7 proceed to group 2 evaluation with the same intervention.

Evaluation of 15 images for each of the proposed 3 grade scale (45 images in total), randomly distributed to validate de scale; images will be assessed twice by the participants with a two-week interval in both study phases (the random distribution will vary between both evaluations).

Together with the assessment of each image the participant is invited to choose one of possible three clinical actions (do nothing, wash with water and wash with simethicone)
Other: Validation of CEBuS
Validation of a new score for bubbles in the colon.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reliability and reproducibility validation of the Colon Endoscopic Bubble Scale (CEBuS)
Time Frame: 1 month

Evaluate the Intraclass correlation coefficients (ICC) and Fleiss kappa test

The Colon Endoscopic Bubble Scale (CEBuS) was designed with a 3 grades scale:

CEBuS-0 - no or minimal amount of bubbles, covering less than 5% of the surface, not relevant for adequate mucosa visibility (better outcome) CEBuS-1 - moderate amount of bubbles, covering between 5% and 50% of the surface, affecting mucosa visibility and requiring additional time for removal CEBuS-2 - severe amount of bubbles, covering more than 50% of the surface, obscuring mucosa visibility and requiring additional time for removal (worse outcome)
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of the clinical attitude
Time Frame: 1 month
Evaluated by the Intraclass correlation coefficients (ICC) and Fleiss kappa test
1 month
Influence of experience in the Colon Endoscopic Bubble Scale (CEBuS)
Time Frame: 1 month

Evaluated by the Intraclass correlation coefficients (ICC) and Fleiss kappa test

The Colon Endoscopic Bubble Scale (CEBuS) was designed with a 3 grades scale:

CEBuS-0 - no or minimal amount of bubbles, covering less than 5% of the surface, not relevant for adequate mucosa visibility (better outcome) CEBuS-1 - moderate amount of bubbles, covering between 5% and 50% of the surface, affecting mucosa visibility and requiring additional time for removal CEBuS-2 - severe amount of bubbles, covering more than 50% of the surface, obscuring mucosa visibility and requiring additional time for removal (worse outcome)
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Portuguese Oncology Institute, Coimbra

Investigators

  • Principal Investigator: Filipe Taveira, MD, Gastroenterology Department of Portuguese Oncology Institute of Coimbra

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2019

Primary Completion (Actual)

March 30, 2020

Study Completion (Actual)

May 14, 2020

Study Registration Dates

First Submitted

May 4, 2020

First Submitted That Met QC Criteria

May 4, 2020

First Posted (Actual)

May 7, 2020

Study Record Updates

Last Update Posted (Actual)

May 15, 2020

Last Update Submitted That Met QC Criteria

May 13, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PortugueseOIC 005

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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