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Effect of Simethicone on Colon Preparation During Water Exchange Colonoscopy
Sponsor: Dalin Tzu Chi General Hospital
Summary
Background: Colonoscopy reduces colorectal cancer mortality by enabling early detection and removal of adenomas. Its effectiveness, however, depends heavily on bowel preparation quality and mucosal visibility. Simethicone, an anti-foaming agent, decreases intraluminal bubbles and improves visualization; studies in conventional air-insufflation colonoscopy generally show benefits for cleanliness and patient comfort, but evidence in water-exchange (WE) colonoscopy remains limited.Objective: To evaluate whether adding oral simethicone to a split-dose polyethylene glycol (PEG) regimen further improves bowel cleanliness and procedural performance in WE colonoscopy.Methods: Adults undergoing outpatient colonoscopy will be randomly assigned (1:1) to a simethicone group or a control group, with a planned enrollment of 180 participants. All procedures will use the WE insertion technique, and endoscopists will be blinded to group allocation. The primary endpoint is the Boston Bowel Preparation Scale (BBPS); adequate preparation is defined as a total score ≥6 with all segment scores ≥2. Secondary endpoints include bubble score and CEBuS, adenoma detection rate (ADR), polyp detection rate (PDR), cecal intubation rate and time, withdrawal time, volume of water used and flushing/irrigation metrics, and patient-reported tolerability and satisfaction.Expected Results: Compared with PEG alone, adding simethicone is expected to (1) increase the proportion of adequate BBPS preparations, (2) reduce bubble coverage, (3) maintain or potentially improve ADR/PDR, and (4) enhance patient tolerability and satisfaction.Conclusion: If effective, this intervention would provide a simple, low-cost strategy to optimize the quality of WE colonoscopy.
Official title: Effects of Simethicone on Colon Preparation in Water Exchange Colonoscopies: a Randomized Controlled Study
Key Details
Gender
All
Age Range
20 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
180
Start Date
2026-08-01
Completion Date
2028-09-01
Last Updated
2026-06-29
Healthy Volunteers
Yes
Conditions
Interventions
Simethicone with PEG
All participants followed a standardized bowel preparation protocol consisting of 10 mg of bisacodyl and 2 liters of PEG solution administered in a split-dose regimen. Participants in the simethicone group additionally received 30 mL of simethicone (600 mg), with 15 mL added to each 1-liter dose of PEG solution.
PEG
All participants followed a standardized bowel preparation protocol consisting of 10 mg of bisacodyl and 2 liters of PEG solution administered in a split-dose regimen.