Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Colon cleansing prior to colonoscopy is critically important to ensure effective colonoscopy for colon cancer screening, which is now widespread in North America. Currently available colon cleansing agents are limited either by potential safety concerns or significant limitations in the ability of patients to tolerate the preparation. Pico-salax has recently been introduced in Canada as an alternative agent and is being used more and more widely despite an almost complete lack of clinical data supporting efficacy and safety. This study will establish the relative efficacy and patient tolerability of this agent and its safety profile. This is a very important, practical issue which continues to challenge gastroenterologists, surgeons, internists, family doctors and thousands of their patients in Canada on a daily basis.
Anecdotal evidence suggests that the efficacy of pico-salax when used as a sole agent may not be as efficacious as oral sodium phosphate. Hence, our hypothesis is that the combination of pico-salax and bisacodyl will provide the most efficacious bowel preparation in comparison with oral sodium phosphate and pico-salax alone, while being equally if not better tolerated.
This is a randomized, investigator blinded clinical trial assessing the cleansing efficacy (using the Ottawa Bowel Preparation scale) and tolerance of three bowel cleansing regimens, two of which involve pico-salax.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | sodium phosphate |
|
| 2 | Active Comparator | picosalax |
|
| 3 | Active Comparator | picosalax plus bisacodyl |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| picosalax plus bisacodyl | Drug | 10 mg bisacodyl three and two nights prior to colonoscopy, followed by two sachets picosalax |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ottawa Bowel Preparation scale | At Colonoscopy. |
| Measure | Description | Time Frame |
|---|---|---|
| Tolerance-Likert scale questionnaire | After Preparation. | |
| Safety Hemodynamics, Blood Chemistry | After Preparation. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Lawrence C Hookey, MD | Queen's University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hotel Dieu Hospital | Kingston | Ontario | K7L 5G2 | Canada |
Not provided
| ID | Term |
|---|---|
| D001726 | Bisacodyl |
| C018279 | sodium phosphate |
| ID | Term |
|---|---|
| D003408 | Cresols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| picosalax | Drug | two sachets of picosalax taken orally the day prior to colonoscopy |
|
| sodium phosphate | Drug | two 45 ml bottles of sodium phosphate the day prior to colonoscopy |
|
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |