Colon Adenoma Clinical Trial
Official title:
Comparison of a Split Dose Bowel Preparation With 2-L Polyethylene Glycol Plus Ascorbic Acid and 1-L Polyethylene Glycol Plus Ascorbic Acid and Bisacodyl Prior to Colonoscopy
Verified date | November 2016 |
Source | Korea University Anam Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | Korea: Ministry for Health and Welfare |
Study type | Interventional |
Recently a low-volume polyethylene glycol containing ascorbic acid (PEG-Asc) formulation has proven as safe and effective as traditional 4-L PEG solutions for colonoscopy preparation. However, currently available aqueous purgative formulations are poorly tolerated. The aim of this study was to compare a split-dose 2-L PEG-Asc and a 1-L PEG-Asc with bisacodyl (10 mg) formulation to determine the quality of bowel cleansing and patient tolerability.
Status | Completed |
Enrollment | 200 |
Est. completion date | December 2015 |
Est. primary completion date | September 2015 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 20 Years to 75 Years |
Eligibility |
Inclusion Criteria: - All patients between the ages of 20 and 75 years who were scheduled to undergo colonoscopy Exclusion Criteria: - aged more than 75 years. - known or suspected gastrointestinal obstruction, Ileus - severe heart failure - uncontrolled hypertension (systolic pressure > 170 mmHg, diastolic pressure > 100 mmHg) - severe constipation - clinically significant electrolyte abnormalities - any prior bowel resection, or significant gastroparesis. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator)
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Korea University Anam Hospital |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The quality of the bowel preparation using preparation scale | Preparation scale | 20 minutes | No |
Secondary | The patient's tolerability | Patients were asked with questionnaires about the symptoms | 30 minutes before the colonoscopy | No |
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