Effect of Simethicone on Bowel Preparation for Colonoscopy
Primary Purpose
Colorectal Cancer
Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
PEG-Asc
PEG-Asc with simethicone
Sponsored by
About this trial
This is an interventional supportive care trial for Colorectal Cancer focused on measuring Bowel preparation, Simethicone, Polyethylene glycol with ascorbic acid
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.
Sites / Locations
- In Kyung Yoo
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
PEG-Asc
PEG-Asc with simethicone
Arm Description
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
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.
Outcomes
Primary Outcome Measures
the quality of the bowel preparation using Preparation Scale
Preparation Scale
Preparation Scale
Secondary Outcome Measures
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.
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".
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.
Full Information
NCT ID
NCT02548403
First Posted
September 8, 2015
Last Updated
September 10, 2015
Sponsor
Korea University Anam Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02548403
Brief Title
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
2. Study Status
Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
July 2014 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
November 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Korea University Anam Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
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
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;
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]
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
Bowel preparation, Simethicone, Polyethylene glycol with ascorbic acid
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
260 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PEG-Asc
Arm Type
Active Comparator
Arm Description
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
Arm Title
PEG-Asc with simethicone
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
PEG-Asc
Other Intervention Name(s)
•Coolprep®; TaeJoon Pharmaceuticals, Seoul, Korea
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
PEG-Asc with simethicone
Other Intervention Name(s)
Coolprep with gasocol® ; TaeJoon Pharmaceuticals, Korea
Intervention Description
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 Measure Information:
Title
the quality of the bowel preparation using Preparation Scale
Description
Preparation Scale
Preparation Scale
Time Frame
20 minutes
Secondary Outcome Measure Information:
Title
Completeness of the bowel preparation
Description
Patient compliance was recorded by checking the completeness of the prescribed preparation methods including bowel cleansing agent solution and recommended clear liquid.
Time Frame
10 minutes
Title
the patient's tolerability[questionnaire]
Description
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".
Time Frame
30 minutes before the colonoscopy
Title
the endoscopist's tolerability[Visual Analog Score for fatigue]
Description
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.
Time Frame
10 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
In kyung Yoo, MD
Organizational Affiliation
Division of Gastroenterology, Department of Internal Medicine, Korea University College of Medicine, Seoul, Republic of Korea
Official's Role
Principal Investigator
Facility Information:
Facility Name
In Kyung Yoo
City
Seoul
State/Province
Anamdong 5-ga, Seongbuk-gu
ZIP/Postal Code
136-705
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Effect of Simethicone on Bowel Preparation for Colonoscopy
We'll reach out to this number within 24 hrs