Effect of Simethicone on Bowel Preparation for Colonoscopy

September 10, 2015 updated by: In-Kyung Yoo, Korea University Anam Hospital

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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]

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
260

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Anamdong 5-ga, Seongbuk-gu
      • Seoul, Anamdong 5-ga, Seongbuk-gu, Korea, Republic of, 136-705
        • In Kyung Yoo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: PEG-Asc
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
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
Other Names:
  • •Coolprep®; TaeJoon Pharmaceuticals, Seoul, Korea
Drug: 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.
Other Names:
  • Coolprep with gasocol® ; TaeJoon Pharmaceuticals, Korea
Active Comparator: PEG-Asc with simethicone
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.
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
Other Names:
  • •Coolprep®; TaeJoon Pharmaceuticals, Seoul, Korea
Drug: 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.
Other Names:
  • Coolprep with gasocol® ; TaeJoon Pharmaceuticals, Korea

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
the quality of the bowel preparation using Preparation Scale
Time Frame: 20 minutes

Preparation Scale

Preparation Scale
20 minutes

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Completeness of the bowel preparation
Time Frame: 10 minutes
Patient compliance was recorded by checking the completeness of the prescribed preparation methods including bowel cleansing agent solution and recommended clear liquid.
10 minutes
the patient's tolerability[questionnaire]
Time Frame: 30 minutes before the colonoscopy
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
the endoscopist's tolerability[Visual Analog Score for fatigue]
Time Frame: 10 minutes
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Korea University Anam Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: In Kyung Yoo, MD, Division of Gastroenterology, Department of Internal Medicine, Korea University College of Medicine, Seoul, Republic of Korea

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 8, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 10, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 14, 2015

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 14, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 10, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Korea University Prep1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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