Clinical trial · Interventional
Effect of Simethicone on Bowel Preparation for Colonoscopy
Use of Simethicone to Improve the Bowel Cleansing Effects of Polyethylene Glycol With Ascorbic Acid for Colonoscopy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PEG-Asc | Drug | — | UNRESOLVED |
| PEG-Asc with simethicone | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- PEG-Asc
- description
- group 1 (PEG-Asc, N=130) received 1 L solution of PEG-Asc at 7 p.m the evening before colonoscopy and another 1 L solution of PEG-Asc at 5 hours before procedure
- interventionNames
- Drug: PEG-Asc
- Drug: PEG-Asc with simethicone
- type
- ACTIVE_COMPARATOR
- label
- PEG-Asc with simethicone
- description
- group 2 (PEG-Asc with simethicone, N=130) received 1 L solution of PEG-Asc at 7 p.m the evening before colonoscopy and another 1 L solution of PEG-Asc at 5 hours before procedure.Two packs (200 mg/10 mL each) of simethicone (400 mg) was mixed with last 500 mL of additional clear fluid.
- interventionNames
- Drug: PEG-Asc
- Drug: PEG-Asc with simethicone
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Male or female patients, * aged between18 and 80 years undergoing elective outpatient colonoscopy were eligible for the study Exclusion Criteria: * patients who had chronic kidney disease, * severe heart failure(New York Heart Association \[NYHA\] class III or IV) * uncontrolled hypertension (systolic pressure ≥170 mm Hg, diastolic pressure ≥100 mm Hg) * severe constipation * any bowel resection * significant gastroparesis, or * suspected bowel obstruction or perforation.
References
Publications (0)
Data not yet available