The Colon Endoscopic Bubble Scale (CEBuS); Validation Study

NCT04378088 | Completed

• 1 other identifier: PortugueseOIC 005
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Colon Polyp

Keywords

Colonoscopy; Quality; Bowel; Preparation

Outcome Measures

Primary Outcomes (1)

• Reliability and reproducibility validation of the Colon Endoscopic Bubble Scale (CEBuS)

  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 Outcomes (2)

• Evaluation of the clinical attitude

  1 month

• Influence of experience in the Colon Endoscopic Bubble Scale (CEBuS)

  1 month

Study Arms (2)

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

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

Interventions

Validation of CEBuS OTHER

Validation of a new score for bubbles in the colon.

Group 1 - experts; Group 2 - mix experts/trainee

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Portuguese Oncology Institute, Coimbra: lead

Study Sites (1)

Portuguese Oncology Institute - Coimbra

Coimbra, 3001 - 651, Portugal

Location

Related Publications (14)

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  PMID: 28268235 BACKGROUND

• Yoo IK, Jeen YT, Kang SH, Lee JH, Kim SH, Lee JM, Choi HS, Kim ES, Keum B, Chun HJ, Lee HS, Kim CD. Improving of bowel cleansing effect for polyethylene glycol with ascorbic acid using simethicone: A randomized controlled trial. Medicine (Baltimore). 2016 Jul;95(28):e4163. doi: 10.1097/MD.0000000000004163.

  PMID: 27428209 BACKGROUND

• Matro R, Tupchong K, Daskalakis C, Gordon V, Katz L, Kastenberg D. The effect on colon visualization during colonoscopy of the addition of simethicone to polyethylene glycol-electrolyte solution: a randomized single-blind study. Clin Transl Gastroenterol. 2012 Nov 29;3(11):e26. doi: 10.1038/ctg.2012.16.

  PMID: 23238113 BACKGROUND

• Pan P, Zhao SB, Li BH, Meng QQ, Yao J, Wang D, Li ZS, Bai Y. Effect of supplemental simethicone for bowel preparation on adenoma detection during colonoscopy: A meta-analysis of randomized controlled trials. J Gastroenterol Hepatol. 2019 Feb;34(2):314-320. doi: 10.1111/jgh.14401. Epub 2018 Aug 27.

  PMID: 30069899 BACKGROUND

• Calderwood AH, Jacobson BC. Comprehensive validation of the Boston Bowel Preparation Scale. Gastrointest Endosc. 2010 Oct;72(4):686-92. doi: 10.1016/j.gie.2010.06.068.

  PMID: 20883845 BACKGROUND

• Rostom A, Jolicoeur E. Validation of a new scale for the assessment of bowel preparation quality. Gastrointest Endosc. 2004 Apr;59(4):482-6. doi: 10.1016/s0016-5107(03)02875-x.

  PMID: 15044882 BACKGROUND

• Aronchick CA, Lipshutz WH, Wright SH, Dufrayne F, Bergman G. A novel tableted purgative for colonoscopic preparation: efficacy and safety comparisons with Colyte and Fleet Phospho-Soda. Gastrointest Endosc. 2000 Sep;52(3):346-52. doi: 10.1067/mge.2000.108480.

  PMID: 10968848 BACKGROUND

• Spada C, Cesaro P, Bazzoli F, Saracco GM, Cipolletta L, Buri L, Crosta C, Petruzziello L, Ceroni L, Fuccio L, Giordanino C, Elia C, Rotondano G, Bianco MA, Simeth C, Consalvo D, De Roberto G, Fiori G, Campanale M, Costamagna G. Evaluation of Clensia(R), a new low-volume PEG bowel preparation in colonoscopy: Multicentre randomized controlled trial versus 4L PEG. Dig Liver Dis. 2017 Jun;49(6):651-656. doi: 10.1016/j.dld.2017.01.167. Epub 2017 Feb 3.

  PMID: 28233684 BACKGROUND

• Repici A, Cestari R, Annese V, Biscaglia G, Vitetta E, Minelli L, Trallori G, Orselli S, Andriulli A, Hassan C. Randomised clinical trial: low-volume bowel preparation for colonoscopy - a comparison between two different PEG-based formulations. Aliment Pharmacol Ther. 2012 Oct;36(8):717-24. doi: 10.1111/apt.12026. Epub 2012 Aug 28.

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• Guo R, Wang YJ, Liu M, Ge J, Zhang LY, Ma L, Huang WY, Zhai HH. The effect of quality of segmental bowel preparation on adenoma detection rate. BMC Gastroenterol. 2019 Jul 8;19(1):119. doi: 10.1186/s12876-019-1019-8.

  PMID: 31286888 BACKGROUND

• Zhang S, Zheng D, Wang J, Wu J, Lei P, Luo Q, Wang L, Zhang B, Wang H, Cui Y, Chen M. Simethicone improves bowel cleansing with low-volume polyethylene glycol: a multicenter randomized trial. Endoscopy. 2018 Apr;50(4):412-422. doi: 10.1055/s-0043-121337. Epub 2017 Nov 13.

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• Rishi M, Kaur J, Ulanja M, Manasewitsch N, Svendsen M, Abdalla A, Vemala S, Kewanyama J, Singh K, Singh N, Gullapalli N, Osgard E. Randomized, double-blinded, placebo-controlled trial evaluating simethicone pretreatment with bowel preparation during colonoscopy. World J Gastrointest Endosc. 2019 Jun 16;11(6):413-423. doi: 10.4253/wjge.v11.i6.413.

  PMID: 31236194 BACKGROUND

• Moraveji S, Casner N, Bashashati M, Garcia C, Dwivedi A, Zuckerman MJ, Carrion A, Ladd AM. The role of oral simethicone on the adenoma detection rate and other quality indicators of screening colonoscopy: a randomized, controlled, observer-blinded clinical trial. Gastrointest Endosc. 2019 Jul;90(1):141-149. doi: 10.1016/j.gie.2019.03.018. Epub 2019 Mar 26.

  PMID: 30926430 BACKGROUND

MeSH Terms

Conditions

Colonic Polyps

Condition Hierarchy (Ancestors)

Intestinal Polyps; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Filipe Taveira, MD

  Gastroenterology Department of Portuguese Oncology Institute of Coimbra

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 4, 2020
• First Posted: May 7, 2020
• Study Start: October 1, 2019
• Primary Completion: March 30, 2020
• Study Completion: May 14, 2020
• Last Updated: May 15, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)