Randomized, double-blinded, placebo-controlled trial evaluating simethicone pretreatment with bowel preparation during colonoscopy

BACKGROUND: The presence of small air bubbles and foam are an impediment to a successful colonoscopy. They impair an endoscopist’s view and diminish the diagnostic accuracy of the study. This has been particularly noted to be of concern with the switch to lower volume polyethylene glycol (PEG) and bisacodyl combination preparation. AIM: To evaluate the effect of oral simethicone addition to bowel preparation on intraluminal bubbles reduction during colonoscopy. METHODS: Described is a prospective, randomized, multi-center, double-blinded, placebo-controlled study to evaluate the use of premixed simethicone formulation with split-regimen, low-volume PEG-bisacodyl combination bowel preparation for 168 outpatients undergoing screening, surveillance, and diagnostic colonoscopies. Primary outcome includes evaluation of bubbles during colonoscopy graded using the Intraluminal Bubbles Scale. Secondary outcomes include evaluation of the Boston Bowel Preparation Scale (BBPS), total number of polyps, polyp size differentiation, polyp laterality, adenoma detection, mass detection, cecal insertion time, withdrawal time, and patient-reported adverse events. RESULTS: Higher Intraluminal Bubbles grades III and IV (less than 75% of the mucosa cleared of bubbles/foam requiring intervention with simethicone infused wash) were detected in the placebo group [Simethicone n = 4/84 vs Placebo n = 20/84 (P = 0.007)]. BBPS total score was 7.42 [standard deviation (SD) = ± 1.51] in the simethicone group and 7.28 (SD = ± 1.44) in the placebo group (P = 0.542) from a total of 9. Significantly higher number of adenomas were detected in the simethicone group (P = 0.001). CONCLUSION: The addition of simethicone to bowel preparation is well advised for its anti-foaming properties. The results of this study suggest that addition of oral simethicone can improve bowel wall visibility.