NCT Number: NCT07674160
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.
Trial opening soon.
Get Notified20 year–80 year
All sexes
Interventional
Not applicable
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: At the time of colonoscopy.
Bowel preparation quality assessed using the Boston Bowel Preparation Scale (BBPS). Adequate preparation is defined as a total score ≥6 with all segment scores ≥2.
Time frame: During the colonoscopy procedure.
Bubble score assessed during colonoscopy using a 4-point scale (0-3) for each colon segment, where higher scores indicate more bubbles.
Time frame: During the colonoscopy procedure.
Bowel cleanliness assessed using the Colon Endoscopic Bubble Scale (CEBuS), categorized based on the percentage of mucosal surface obscured by bubbles (e.g., <5%, 5-50%, >50%).Higher scores indicate poorer visibility due to bubbles.
Time frame: one week
Time frame: one week
Time frame: At the time of colonoscopy.
Proportion of procedures in which the cecum is successfully reached.
Time frame: During the colonoscopy procedure.
Time from insertion to successful cecal intubation, measured in minutes.
Time frame: During the colonoscopy procedure.
Time from cecal intubation to scope withdrawal, measured in minutes.
Time frame: During the procedure.
Total volume of water infused during colonoscopy, measured in milliliters.
Time frame: During the procedure
Total volume of fluid aspirated during colonoscopy, measured in milliliters.
Time frame: Immediately after the procedure.
Pain assessed using a visual analog scale (VAS) ranging from 0 (no pain) to 10 (worst pain imaginable).
Time frame: Immediately after the procedure.
Patient satisfaction assessed using a numeric rating scale from 0 to 10, where higher scores indicate greater satisfaction.
Contact information is provided by the study sponsor or research team.
Dalin Tzu Chi General Hospital
Other
Effects of Simethicone on Colon Preparation in Water Exchange Colonoscopies: a Randomized Controlled Study
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
