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The objective of this study is to evaluate sennosides as an adjunct to sodium picosulfate magnesium citrate (Pico Salax) in preparation for colonoscopy. We will compare different doses and administration times. The primary outcome is number of bowel motions produced. Secondary outcomes include the quality of bowel cleansing and patient tolerability.
We will compare different doses and administration times in patients booked for morning colonoscopy. The primary outcome is number of bowel motions produced in total by the sennosides. Secondary outcomes include the quality of bowel cleansing and patient tolerability.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 2 TABS QHS | Active Comparator | Sennosides 2 tabs, taken two nights before the colonoscopy |
|
| 3 TABS QHS | Active Comparator | Sennosides 3 tabs, taken two nights before the colonoscopy |
|
| 2 TABS AM | Active Comparator | Sennosides 2 tabs, taken the morning before the colonoscopy |
|
| 3 TABS AM | Active Comparator | Sennosides 3 tabs, taken the morning before the colonoscopy |
|
| 2 TABS AM & QHS | Active Comparator | Sennosides 2 tabs taken the morning before and 2 tabs taken the evening before the colonoscopy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sennosides | Drug | Each group will be assigned different doses of sennosides and varying times of administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Bowel movements, as measured by patient diary | The primary outcome of this pilot study is the number of bowel movements. Patients will record the timing and number of bowel motions produced. | 2 days |
| Measure | Description | Time Frame |
|---|---|---|
| Colon cleansing, as measured by The Ottawa Scale and Aronchick Bowel Cleansing Scale | The secondary outcome is colon cleansing efficacy. The endoscopist will grade the cleansing quality of the colon using two standardized measures - the Ottawa Scale and the 5-point Aronchick Bowel Preparation Scale | 2 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lawrence Hookey | Queen's University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hotel Dieu Hospital | Kingston | Ontario | K7L 5G2 | Canada | ||
| Hotel Dieu Hospital |
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| ID | Term |
|---|---|
| D000081226 | Sennosides |
| ID | Term |
|---|---|
| D012676 | Senna Extract |
| D000880 | Anthraquinones |
| D000095322 | Anthrones |
| D000873 | Anthracenes |
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|
| Tolerability, as measured by patient questionnaire |
The secondary outcome is patient tolerability. Patients will be asked to complete a questionnaire examining symptoms such as nausea, bloating, vomiting, and abdominal pain. |
| 2 days |
| Kingston |
| Ontario |
| K7L5G2 |
| Canada |
| D011084 |
| Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011809 | Quinones |
| D011083 | Polycyclic Compounds |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D010936 | Plant Extracts |
| D028321 | Plant Preparations |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |