A Randomized Controlled Trial Comparing Picosalax and Oral Sodium Phosphate for Colon Cleansing Prior to Colonoscopy

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Randomized Controlled Trial Comparing Picosalax and Oral Sodium Phosphate for Colon Cleansing Prior to Colonoscopy

Conditions
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Colonoscopy

Intervention / Treatment
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* Drug: picosalax plus bisacodyl
* Drug: picosalax
* Drug: sodium phosphate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Consecutive male and non-pregnant female patients ≥ 18 years old who require outpatient colonoscopy will be approached to consider participation in the study. Exclusion Criteria: ileus or bowel obstruction; previous colorectal surgery; renal impairment; pregnancy; recent (<6 months) myocardial infarction or unstable angina.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>sodium phosphate | Drug: sodium phosphate<br>* two 45 ml bottles of sodium phosphate the day prior to colonoscopy<br>|
| Active Comparator: 2<br>picosalax | Drug: picosalax<br>* two sachets of picosalax taken orally the day prior to colonoscopy<br>|
| Active Comparator: 3<br>picosalax plus bisacodyl | Drug: picosalax plus bisacodyl<br>* 10 mg bisacodyl three and two nights prior to colonoscopy, followed by two sachets picosalax<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ottawa Bowel Preparation scale |  | At Colonoscopy. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tolerance-Likert scale questionnaire |  | After Preparation. | 
| Safety Hemodynamics, Blood Chemistry |  | After Preparation. |