Effect of Simethicone on Bowel Preparation for Colonoscopy

Phase

Condition

Rectal Cancer

Colorectal Cancer

Colon Cancer; Rectal Cancer

Treatment

N/A

Clinical Study ID

NCT02548403

Korea University Prep1

Ages 18-80
All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Male or female patients,
aged between18 and 80 years undergoing elective outpatient colonoscopy were eligiblefor the study

Exclusion

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 mmHg)
severe constipation
any bowel resection
significant gastroparesis, or
suspected bowel obstruction or perforation.

Study Design

July 01, 2014

November 30, 2014

Study Description

Study design: endoscopist-blinded, prospective, randomized controlled trial
Subjects
- A single-center, randomized, observer-blinded study was performed at Korea University Hospital in Anam. Outpatients were prospectively enrolled. Each group of the patients will receive PEG-Asc or PEG-Asc with simethicone before colonoscopy.
Sampling design: Consecutive recruitment of consenting patients
Variables Predictor
1. group 1 (PEG-Asc) 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;
2. group 2 (PEG-Asc with simethicone) 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.
Primary Outcome: Quality of bowel preparation [Boston Bowel Preparation Scale, bubble score]
Secondary Outcome: Patients and endoscopists' compliance[Tolerability, palatability of patient, fatigue score of endoscopist]

Connect with a study center

In Kyung Yoo
Seoul, Anamdong 5-ga, Seongbuk-gu 136-705
Korea, Republic of
Site Not Available

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