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The primary objective of this study is to compare the efficacy of administration routine bowel cleansing medication (Bowklean) for the Bowel Preparation at Different Times Prior Colonoscopy in the morning or in the afternoon.
Sodium picosulfate/magnesium citrate (SPMC) is a small-volume bowel cleansing agent with similar efficacy and better tolerability than polyethylene glycol. However, there was limited data about the bowel cleansing efficacy of SPMC in comparing the same-day and split-dose preparation for afternoon colonoscopy.
This randomized, single-center, endoscopist-blinded, non-inferior study compared same-day (101 subjects) and split-dose (96 subjects) preparation with SPMC for afternoon colonoscopy. One additional prospective observation group of 100 subjects receiving colonoscopy in the morning was included as an observation group to compare bowel preparation in morning and afternoon colonoscopy. Efficacy of bowel cleansing was evaluated by the Aronchick Scale, Ottawa Bowel Preparation Scale (OBPS), Boston Bowel Preparation Scale (BBPS), and the Bubble Scale (TBS).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| split dose, day before, colonoscopy in the morning (Observation Group) | Active Comparator | routine bowel preparation before colonoscopy in the morning |
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| split dose, day before, colonoscopy in the afternoon (Random) | Active Comparator | routine bowel preparation before colonoscopy in the afternoon |
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| two dose in the same day, colonoscopy in the afternoon (Random) | Experimental | experimental group |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bowklean | Drug | assigned intervention |
|
| Measure | Description | Time Frame |
|---|---|---|
| Aronchick Scale Bowel Cleaning Scale | Aroochick Scale ranges from score 1 : excellent, 2: good, 3: fair, 4: poor 5: failed | during colonoscopy |
| Measure | Description | Time Frame |
|---|---|---|
| Boston Bowel Preparation Scale (BBPS) Bowel Cleaning Scale | The Boston Bowel Preparation Scale Score 0 : inadequate ; Score 1: fair ;Score 2: good; Score 3: excellent . min : 0 , max: 3 | During Colonoscopy |
| Colonscopy Bubble Scale |
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Inclusion Criteria:
Exclusion Criteria:
Patients who are not suitable for colonoscopy
Any prior colorectal surgery
Severe chronic constipation
Hypersensitivity to any ingredient in the study medication
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| Name | Affiliation | Role |
|---|---|---|
| HsuHeng Yen, MD | Changhua Christian Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hsu-Heng Yen | Changhua | 500 | Taiwan |
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The 1st group: split dose, day before, colonoscopy in the morning. The 2nd group: split dose, day before, colonoscopy in the afternoon. The 3rd group: same day, colonoscopy in the afternoon.
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Colon Bubble Scale : Grade A : no bubble , Grade B: little bubble , Grade C: bubble of half of the lumen , Grade D: bubble of entire lumen. Grade A means the best and Grade D means the worst.
| During Colonoscopy |