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| Name | Class |
|---|---|
| Daehang Hospital | OTHER |
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Colonoscopy is considered by many the preferred mode of screening for colorectal cancer (CRC). The effectiveness of any CRC screening program is critically dependent on an adequate bowel preparation.
For bowel preparation, effective, well-tolerated and safe methods should be applied.
Recently, oral sulfate solution was adopted to Korea. Still, in Korea, there was no data of direct comparison of 2L polyethylene glycol with ascorbic acid (PEG-Asc) and oral sulfate solution (OSS) in split method for bowel preparation. Therefore, in this study, we planned the comparative evaluation the efficacy of PEG-Asc and OSS in split method for bowel preparation
For direct comparison of 2L polyethylene glycol with ascorbic acid (PEG-Asc) and oral sulfate solution (OSS) in split method for bowel preparation
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HAPREP® (PEG-Asc) | Active Comparator | subjects randomized to 2L polyethylene glycol with ascorbic acid (PEG-Asc) were instructed to use PEG-Asc for bowel preparation : PEG-Asc(500mLx2 times q30min)[PM 7-9, the day before colonoscopy] + PEG-Asc(500mLx2 times q30min)[AM 5-7, the day of colonoscopy] |
|
| SUCLEAR® (OSS) | Experimental | subjects randomized to oral sulfate solution were instructed to use oral sulfate solution (OSS) for bowel preparation : OSS(1b/177mL)[PM 7-9, the day before colonoscopy] + OSS(1b/177mL)[AM 5-7, the day of colonoscopy] |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HAPREP® | Drug | Arm1: HAPREP® (2L polyethylene glycol with ascorbic acid; PEG-Asc) : : PEG-Asc(500mLx2 times q30min)[PM 7-9, the day before colonoscopy] + PEG-Asc(500mLx2 times q30min)[AM 5-7, the day of colonoscopy] |
| Measure | Description | Time Frame |
|---|---|---|
| Adequacy of bowel preparation | on the day of colonoscopy |
| Measure | Description | Time Frame |
|---|---|---|
| 5-point scale symptom questionnaire for drug tolerability | 4(distressing) or 5(severely distressing) point would be untolerable | on the day of colonoscopy |
| Number of Participants with Adverse Events |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dae Kyung Sohn, M.D. | National Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Cancer Center | Goyang-si | Gyeonggi-do | 410-769 | South Korea |
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| ID | Term |
|---|---|
| D011092 | Polyethylene Glycols |
| ID | Term |
|---|---|
| D005026 | Ethylene Glycols |
| D006018 | Glycols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| SUCLEAR® | Drug | Arm2: SUCLEAR® (oral sulfate solution; OSS): OSS(1b/177mL)[PM 7-9, the day before colonoscopy] + OSS(1b/177mL)[AM 5-7, the day of colonoscopy] |
|
|
| on the day of colonoscopy |
| colonoscopy insertion time | on the day of colonoscopy |
| adenoma detection rate | whithin 3 weeks from the day of colonoscopy |
| D011108 |
| Polymers |
| D046911 | Macromolecular Substances |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |