Ignite Creation Date:
2025-12-24 @ 7:49 PM
Ignite Modification Date:
2026-02-10 @ 10:04 PM
Study NCT ID:
NCT02548403
Status:
COMPLETED
Last Update Posted:
2015-09-14
First Post:
2015-09-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Simethicone on Bowel Preparation for Colonoscopy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012841', 'term': 'Simethicone'}], 'ancestors': [{'id': 'D004129', 'term': 'Dimethylpolysiloxanes'}, {'id': 'D012828', 'term': 'Silicones'}, {'id': 'D012833', 'term': 'Siloxanes'}, {'id': 'D017646', 'term': 'Organosilicon Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011108', 'term': 'Polymers'}, {'id': 'D046911', 'term': 'Macromolecular Substances'}, {'id': 'D001697', 'term': 'Biomedical and Dental Materials'}, {'id': 'D008420', 'term': 'Manufactured Materials'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 260}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'completionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-09-10', 'studyFirstSubmitDate': '2015-09-08', 'studyFirstSubmitQcDate': '2015-09-10', 'lastUpdatePostDateStruct': {'date': '2015-09-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-09-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the quality of the bowel preparation using Preparation Scale', 'timeFrame': '20 minutes', 'description': 'Preparation Scale\n\nPreparation Scale'}], 'secondaryOutcomes': [{'measure': 'Completeness of the bowel preparation', 'timeFrame': '10 minutes', 'description': 'Patient compliance was recorded by checking the completeness of the prescribed preparation methods including bowel cleansing agent solution and recommended clear liquid.'}, {'measure': "the patient's tolerability[questionnaire]", 'timeFrame': '30 minutes before the colonoscopy', '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".'}, {'measure': "the endoscopist's tolerability[Visual Analog Score for fatigue]", 'timeFrame': '10 minutes', '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.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Bowel preparation', 'Simethicone', 'Polyethylene glycol with ascorbic acid'], 'conditions': ['Colorectal Cancer']}, 'descriptionModule': {'briefSummary': '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.\n\nA 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.\n\nTo the investigators knowledge, no previous study has assessed colon preparation in patients administered simethicone.\n\nThe 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.', 'detailedDescription': "1. Study design: endoscopist-blinded, prospective, randomized controlled trial\n2. Subjects\n\n \\- 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.\n3. Sampling design: Consecutive recruitment of consenting patients\n4. Variables Predictor\n\n 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;\n 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.\n5. Primary Outcome: Quality of bowel preparation \\[Boston Bowel Preparation Scale, bubble score\\]\n6. Secondary Outcome: Patients and endoscopists' compliance\\[Tolerability, palatability of patient, fatigue score of endoscopist\\]"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female patients,\n* aged between18 and 80 years undergoing elective outpatient colonoscopy were eligible for the study\n\nExclusion Criteria:\n\n* patients who had chronic kidney disease,\n* severe heart failure(New York Heart Association \\[NYHA\\] class III or IV)\n* uncontrolled hypertension (systolic pressure ≥170 mm Hg, diastolic pressure ≥100 mm Hg)\n* severe constipation\n* any bowel resection\n* significant gastroparesis, or\n* suspected bowel obstruction or perforation.'}, 'identificationModule': {'nctId': 'NCT02548403', 'briefTitle': 'Effect of Simethicone on Bowel Preparation for Colonoscopy', 'organization': {'class': 'OTHER', 'fullName': 'Korea University Anam Hospital'}, 'officialTitle': 'Use of Simethicone to Improve the Bowel Cleansing Effects of Polyethylene Glycol With Ascorbic Acid for Colonoscopy', 'orgStudyIdInfo': {'id': 'Korea University Prep1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'PEG-Asc', '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', 'interventionNames': ['Drug: PEG-Asc', 'Drug: PEG-Asc with simethicone']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'PEG-Asc with simethicone', '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.', 'interventionNames': ['Drug: PEG-Asc', 'Drug: PEG-Asc with simethicone']}], 'interventions': [{'name': 'PEG-Asc', 'type': 'DRUG', 'otherNames': ['•Coolprep®; TaeJoon Pharmaceuticals, Seoul, Korea'], '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', 'armGroupLabels': ['PEG-Asc', 'PEG-Asc with simethicone']}, {'name': 'PEG-Asc with simethicone', 'type': 'DRUG', 'otherNames': ['Coolprep with gasocol® ; TaeJoon Pharmaceuticals, Korea'], '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.', 'armGroupLabels': ['PEG-Asc', 'PEG-Asc with simethicone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '136-705', 'city': 'Seoul', 'state': 'Anamdong 5-ga, Seongbuk-gu', 'country': 'South Korea', 'facility': 'In Kyung Yoo', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'In kyung Yoo, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Division of Gastroenterology, Department of Internal Medicine, Korea University College of Medicine, Seoul, Republic of Korea'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Korea University Anam Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'fellow', 'investigatorFullName': 'In-Kyung Yoo', 'investigatorAffiliation': 'Korea University Anam Hospital'}}}}