Clinical trial NCT02548403: Effect of Simethicone on Bowel Preparation for Colonoscopy
Official title: Use of Simethicone to Improve the Bowel Cleansing Effects of Polyethylene Glycol With Ascorbic Acid for Colonoscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Colorectal Cancer
Keywords: Bowel preparation
Simethicone
Polyethylene glycol with ascorbic acid
Lead sponsor: Korea University Anam Hospital
Sponsor class: OTHER
First posted: 2015-09-14
Enrollment: 260
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed description: 1. Study design: endoscopist-blinded, prospective, randomized controlled trial
2. 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.
3. Sampling design: Consecutive recruitment of consenting patients
4. 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.
5. Primary Outcome: Quality of bowel preparation \[Boston Bowel Preparation Scale, bubble score\]
6. Secondary Outcome: Patients and endoscopists' compliance\[Tolerability, palatability of patient, fatigue score of endoscopist\]

Eligibility 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.

Primary outcomes:
measure: the quality of the bowel preparation using Preparation Scale
timeFrame: 20 minutes
Secondary outcomes:
measure: Completeness of the bowel preparation
timeFrame: 10 minutes
measure: the patient's tolerability[questionnaire]
timeFrame: 30 minutes before the colonoscopy
measure: the endoscopist's tolerability[Visual Analog Score for fatigue]
timeFrame: 10 minutes
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: In Kyung Yoo
state: Anamdong 5-ga, Seongbuk-gu
Study officials:
affiliation: Division of Gastroenterology, Department of Internal Medicine, Korea University College of Medicine, Seoul, Republic of Korea
name: In kyung Yoo, MD
role: PRINCIPAL_INVESTIGATOR
References: