Comparison Between a 1L of Polyethylene Glycol+Ascorbic Acid as a Split Dose Bowel Preparation for Colonoscopy
- Registration Number
- NCT04758156
- Lead Sponsor
- Seoul National University Hospital
- Brief Summary
Comparison between a 1L of polyethylene glycol+ascorbic acid as a split dose and oral sulfate solution bowel preparation for colonoscopy
study design: prospective, randomized, parallel, multi-center trial in 3 hospitals in Korea ( Seoul National University hospital, Seoul National University Bundang hospital, Seoul Metropolitan Government-Seoul National University )
patient inclusion criteria
- aged 20-75 adults (out-clinic patients) scheduled for colonoscopy for any indication within the normal process of care
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 200
- Adult out clinic patients scheduled for colonoscopy for any indication within the normal process of care
- previous history of significant gastrointestinal surgeries (except for appendectomy)
- known or clinically suspicious Inflammatory bowel disease patients
- known or suspected ileus/ GI obstruction
- previous history of major cancer or currently on treating cancer
- Major cardiovascular disease, respiratory disease, liver, hematologic diseases with complication
- severe cognitive impairment / dementia / confusion state
- past history within the last 12 months or current episode of severe constipation severe constipation
- Regular use of laxatives or colon motility-altering drugs (i. e. more than 2 - 3 times per week) in the last 28 days prior to screening and/or laxative use within 72 hours prior to administration of the preparation)
- women who are pregnant or lactating
- known phenylketonuria, glucose-6-phosphate dehydrogenase deficiency
- those who were allergic to any preparation components.
- those who, in the opinion of the investigator, should not be included in the study for any reason
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CleanViewAL CleanViewAL 1L polyethylene glycol+ascorbic acid split dose SUPREP SUPREP Oral sulfate solutiom
- Primary Outcome Measures
Name Time Method Boston Bowel Preparation Scale (BBPS) at the time of colonoscopy procedure Bowel cleansing score
- Secondary Outcome Measures
Name Time Method questionnaire gathered for Tolerability, compliance, satisfaction on the 1 day of colonoscopy via questionnaire information gathered via questionnaire
Trial Locations
- Locations (1)
Seoul national university hospital
🇰🇷Seoul, Korea, Republic of