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Adequate bowel cleansing is essential for effective colonoscopy. Acceptance of colon preparation affects the quality of colon cleansing. The study is aimed at comparing the efficacy, safety and acceptability of sodium picosulphate/magnesium citrate (PMC) and low-volume PEG -ascorbic acid (PEG+ASC)in colon cleansing, and to identify predictors of poor bowel preparation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| sodium picosulphate/magnesium citrate | Experimental |
| |
| low-volume PEG -ascorbic acid | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sodium picosulphate magnesium citrate | Drug | Use of the product in colon cleansing before colonoscopy. Two sachets each containing 10 mg of sodium picosulfate, 3.5 g magnesium oxide and 12.0 g citric acid. The 2 doses are taken diluted in a glass water. |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of bowel cleansing | Assessment of quality of colon cleansing at colonoscopy as achieved by the two study products | Within 24 hrs |
| Measure | Description | Time Frame |
|---|---|---|
| Safety | Occurrence of complications related to the intake or the two study products | In the 24 hours within assumption of study products |
| Tolerability | Acceptability of the two study products in term of palatability and ease to take the products |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gianpiero Manes, MD | Ospedale L. Sacco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ospedale Valduce, Gastroenterologia | Como | 22100 | Italy | |||
| Ospedale S. Paolo |
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| ID | Term |
|---|---|
| C520497 | MoviPrep |
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| low-volume PEG -ascorbic acid | Drug | THe product is used as colon cleanser before colonoscopy. It is supplied as a powder for oral use, to be reconstituted with 2 L of water and drunk as a solution. It consists of 100.0 g macrogol 3350 plus electrolytes (7.5 g sodium sulphate, 2.7 g sodium chloride, 1.0 g potassium chloride) and 4.7 g ascorbic acid. |
|
|
| Within 12 hrs |
| Milan |
| 20142 |
| Italy |
| Ospedale L. Sacco, Endoscopic Unit | Milan | 20157 | Italy |