Effect of Simethicone on Bowel Preparation for Colonoscopy

Colorectal Cancer Clinical Trial

Official title:

Use of Simethicone to Improve the Bowel Cleansing Effects of Polyethylene Glycol With Ascorbic Acid for Colonoscopy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02548403
• Other study ID #: Korea University Prep1
• Status: Completed
• Phase: Phase 3
• First received: September 8, 2015
• Last updated: September 10, 2015
• Start date: July 2014
• Est. completion date: November 2014

Study information

• Verified date: September 2015
• Source: Korea University Anam Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Ministry for Health and Welfare
• Study type: Interventional

Clinical Trial 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.

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]

Recruitment information / eligibility

• Status: Completed
• Enrollment: 260
• Est. completion date: November 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Colorectal Cancer

Intervention

Drug:
• 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
• 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.

Locations

Country	Name	City	State
Korea, Republic of	In Kyung Yoo	Seoul	Anamdong 5-ga, Seongbuk-gu

Sponsors (1)

Lead Sponsor	Collaborator
Korea University Anam Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the quality of the bowel preparation using Preparation Scale	Preparation Scale; Preparation Scale	20 minutes	No
Secondary	Completeness of the bowel preparation	Patient compliance was recorded by checking the completeness of the prescribed preparation methods including bowel cleansing agent solution and recommended clear liquid.	10 minutes	No
Secondary	the patient's tolerability[questionnaire]	Patients were asked with questionnaires about the symptoms associated with the preparation to assess the patients' tolerability before the colonoscopy. Patients were asked whether they experienced any of the following : abdominal fullness, cramping, nausea, vomiting, sleep disturbance, and overall discomfort, and these symptoms were scored on a 5-point scale where 1 = "none", 2 = "mild", 3 = "moderate", 4 = "severe", and 5 = "very severe".	30 minutes before the colonoscopy	Yes
Secondary	the endoscopist's tolerability[Visual Analog Score for fatigue]	Endoscopist fatigue during colonoscopy was scored using a Visual Analog Scale, ranging from 1-10, where 1 and 10 represented "strongly disagree" and "strongly agree", respectively.	10 minutes	No