Who is sponsoring NCT02334631?

NCT02334631 is sponsored by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's.

What condition does NCT02334631 study?

NCT02334631 studies Small Bowel Diseases.

What drugs are being tested in NCT02334631?

Interventions: High Volume Simethicone, Standard Volume Simethicone.

What is the status of NCT02334631?

NCT02334631 is currently COMPLETED.

Last reviewed 2020-01-07 · How we verify

A Double Blind Randomized Controlled Trial of High Volume Simethicone to Improve Visualization During Capsule Endoscopy

NCT02334631 Phase 4 COMPLETED

Video capsule endoscopy (VCE) is a procedure where a small camera is swallowed to examine the small bowel. Although the procedure is useful for diagnosing small bowel diseases, air bubbles can obscure the recorded images. Simethicone is a medication that can be used to disperse the air bubbles. However, prior studies using this medication have shown only a modest benefit. In our study, we would like to investigate whether increasing the amount of medication will improve the recorded images further.

Details

Lead sponsor	London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Phase	Phase 4
Status	COMPLETED
Enrolment	159
Start date	2017-01
Completion	2019-10

Conditions

Small Bowel Diseases

Interventions

High Volume Simethicone
Standard Volume Simethicone

Primary outcomes

Visualization quality — Once during review of capsule images
Visualization quality will be scored in a blinded fashion using a validated score developed by Park et al. (World J Gastroenterol 2010;16(7):875-80.) Representative images from the small bowel will be serially selected at five-minute intervals. Each image is evaluated for two parameters: the proportion of visualized mucosa (VM) and degree of obscuration (DO) by bubbles, debris etc. The proportion of visualized mucosa is scored on a three- point scale: \> 75% = 3, 50% to 75% = 2, 25% to 50% = 1, \<25% = 0. The degree of obscuration is also scored in a three point scale: \< 5 % = 3, 5% to 25% = 2, 25% to 50% = 1, \> 50 % = 0. Mean scores for each parameter are obtained by dividing the sum of all images scored by the number of images. Finally the average of the two parameters is calculated. Both the whole, proximal, and distal small bowel will be scored separately. The first half of the small bowel will be considered proximal while the second half will be considered distal.

Countries

Canada