Overview

Effect of Simethicone on Bowel Preparation for Colonoscopy

Status:
Completed
Trial end date:
2014-11-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Korea University Anam Hospital
Treatments:
Ascorbic Acid
Pharmaceutical Solutions
Simethicone
Criteria
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.