Colon Adenoma, Colonic Polyp
Conditions
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
Interventions
DRUGCleanViewAL
1L PEG + ascorbic acid bowel preparation for colonoscopy
DRUGSUPREP
Oral sulfate solution for colonoscopy bowel preparation
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* Adult out clinic patients scheduled for colonoscopy for any indication within the normal process of care
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Boston Bowel Preparation Scale (BBPS) | at the time of colonoscopy procedure | Bowel cleansing score |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| questionnaire gathered for Tolerability, compliance, satisfaction | on the 1 day of colonoscopy via questionnaire | information gathered via questionnaire |
Countries
South Korea
Contacts
Primary ContactHyun Jung Lee, MD, PhD
Outcome results
None listed