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The investigators will compare with PEG+ascorbic acid and picosulfate+magnesium citrate about bowel preparation, patient's satisfaction, side effects to identify effectiveness of new bowel preparation drug.
The investigators can find easily colon cancer and poly by colonoscopy, but bowel preparation is very important to find the lesion. Desirable bowel preparation drug must be clearly removed stool, effective on colonoscopic finding and pathologic finding, quickly administrated agent and eliminated stool, comfort for patient, and less side effects.
PEG is very safe osmotic laxative. New agent(coolprep) which add ascorbic acid is less salty and less volume. Picosulfate+magnesium citrate(picolyte) taste orange, can be easily prepared bowel for colonoscopy by good taste and small volume. Magnesium with citrate acts like osmotic agent, picosulfate acts irritant agent.
The investigators will compare with PEG+ascorbic acid and picosulfate+magnesium citrate about bowel preparation, patient's satisfaction, side effects to identify effectiveness of new bowel preparation drug.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Coolprep | A total of 2L A : NaCl 5.382g KCl 2.03g Sodium sulfate 15g Polyethylene glycol 3350 200.0g B : Ascorbic acid 9.4g Sodium ascorbate 11.8g | ||
| Picolyte | Sodium picosulfate 30.0mg Magnesium citrate 10.5g + 36.0g |
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| Measure | Description | Time Frame |
|---|---|---|
| Ottawa scale | * Ottawa scale Individual evaluation of right, mid, and left colon: No liquid - 0 Minimal liquid, no suctioning required - 1 Suction required to see mucosa - 2 Wash and suction - 3 Solid stool,not washable - 4 Evaluation of the entire colon: Overall quantity of fluid 0-2 minimal -0 moderate - 1 Large - 2 * Aronchick score scale Minimal liquid, visible more than 95% of colon mucosa - excellent Clear liquid covered 5~25% of mucosa, visible more than 90% of colon mucosa - good Solid stool, washable, visible more than 90% of colon mucosa - Fair Solid stool, not washable, visible less than 90% of colon mucosa not washable - Poor Bowel preparation is needed - Inadequate | Ottawa scale will be checked at the end of the colonoscopy. Participants won't be followed up because of this study. |
| Measure | Description | Time Frame |
|---|---|---|
| Patient satisfaction | Taste, Comfort | Questionnaires related with satisfaction and side effects will be written just befor colonoscopy. Participants won't be followed up because of this study. |
| Symptoms related with bowel preparation |
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Inclusion Criteria:
Exclusion Criteria:
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This study will include a total of 250 patients. All patient randomized PEG+ascorbica acid(coolprep) and picosulfate magnesium citrate(picolyte), each group will include 125 patients.
The investigators decided sample size to 200 patients after comparing Ottawa scale. The investigators assumed there would be defference about 20 percent of bowel preparation between them. Recently, Ottawa scale of bowel preparation reported about 5 points. The investigators assumed that there could be differences between them about 1 point. The investigators decided each groups per 100 patients, if significance level was 0.05 and test power is 80 percent. The investigators start this study with a total of 220 patients because 10 percent of 200 patients could be drop out. The investigators readjust about 30 patients after interim analysis.
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| Name | Affiliation | Role |
|---|---|---|
| Jun Won Chung, Professor | Gachon University Gil Medical School | Study Director |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Sep 16, 2015 | |
| Reset | Oct 14, 2015 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Sep 16, 2015 | Oct 14, 2015 |
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Nausea, Vomiting, Abdominal discomfort, Abdominal distension, Headache, Dizziness, Numbness
| Questionnaires related with side effects will be written just befor colonoscopy. Participants won't be followed up because of this study. |