drugset / Trial / NCT02548403

Effect of Simethicone on Bowel Preparation for Colonoscopy

NCT02548403

Phase 3 Completed 260 enrolled Korea University Anam Hospital
RandomizedParallel-groupSingle-blindSupportive care

Summary

Optimal bowel preparation is essential for colonoscopy efficacy and safety. Mucosal visualization during colonoscopy is often limited by residual stool, bubbles, bile, intraluminal fluid, and debris, which increase the risk of missing flat adenomas or other small lesions.Therefore, intestinal preparation is necessary to remove residual materials prior to endoscopy. A combined agent, low-dose PEG with ascorbic acid (PEG-Asc), is one low-volume solution commonly used in Korea (Coolprep®; TaeJoon Pharmaceuticals, Seoul, Korea). However, practitioners have noted an increased incidence of bubble formation with this preparation method. To the investigators knowledge, no previous study has assessed colon preparation in patients administered simethicone. The purpose of this study was to compare the quality of bowel preparation and compliance between PEG-Asc and PEG-Asc with simethicone. The effectiveness of adding simethicone as an antifoaming agent to improve bowel cleansing for colonoscopy was evaluated in terms of bowel preparation scale and bubble score, and the compliance of both patients and endoscopists was also investigated using a questionnaire.

Timeline

Start
2014-07
Primary completion
2014-09
Completion
2014-11

Drugs

EvaluationDrugModalityDoseRoute
Comparator Simethicone Other / unclassified 400 mg
Comparator PEG-Asc Unknown 1000 ml

Indications