Phase 4
Completed N=268
Effect of Simethicone on Screening Colonoscopy
Adenoma Colon
Source: ClinicalTrials.gov NCT03119168 ↗
Enrolled (actual)
268
Serious AEs
0.0%
Results posted
Jun 2019
Primary outcomePrimary: Adenoma Detection Rate — 43; 54 adenomas
◆ Published Evidence
Highly cited
489citations · ~24 / year
Quality indicators for colonoscopy.
Summary
This study is evaluating the effect of adding a high dose of simethicone to the standard polyethylene glycol preparation for screening colonoscopy in the quality of the preparation , adenoma detection rate and withdrawal times.
Linked Publications (3)
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Quality indicators for colonoscopy.
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A predictive model identifies patients most likely to have inadequate bowel preparation for colonoscopy.
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The role of oral simethicone on the adenoma detection rate and other quality indicators of screening colonoscopy: a randomized, controlled, observer-blinded clinical trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Adenoma Detection Rate |
43; 54 | — |
| SECONDARY Withdrawal Times |
395.7; 399 | — |
| SECONDARY Colon Preparation |
8.9; 8.9; 0.1; 2.1 | — |
| SECONDARY Intraprocedural Use of Simethicone |
2; 68 | — |
Eligibility Criteria
Inclusion Criteria
- Patients between the ages of 30-80 scheduled for screening colonoscopy.
- Male and female patients
- Ambulatory patients
- Signed informed consent form
Exclusion Criteria
- Previous colonic surgery
- Patient with mental/physical condition that impairs oral ingestion of preparation
- Allergy or hypersensitivity to simethicone
- Patients with limited mobility (bedridden patients)
- Patients with gastrointestinal obstruction
- Patients with gastroparesis
Data sourced from ClinicalTrials.gov (NCT03119168) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.