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SAFETY, EFFICACY, AND TOLERANCE OF PICO-SALAX FOR COLON CLEANSING PRIOR TO COLONOSCOPY IN AN ELDERLY POPULATION
S Fowler, L Hookey, S Vanner
Gastrointestinal Diseases Research Unit, Kingston, Ontario
Aims: Colon cleansing prior to colonoscopy is essential for an adequate examination. A recent trial at our center found that Pico-salax, a relatively new agent to the Canadian market, was better tolerated than oral sodium phosphate and when combined with bisacodyl provided superior cleansing of the right side of the colon, an area of concern for flat neoplasia and missed colonic polyps and cancers. Pico-salax has been widely adopted in Canada although there remains variability in timing and total dose prescribed. There is also a paucity of data on the physiologic effects of Pico-salax in the general population. This is of particular importance in the elderly as this population can have different bowel motility, hydration, and renal function compared to younger patients. This trial is designed to study the safety, efficacy, and tolerance of Pico-salax for colon cleansing prior to colonoscopy in an elderly population.
Methods: This is a prospective, observational study of patients >= 70 years old who are undergoing outpatient colonoscopy. All patients undergo pre-preparation screening including estimation of renal function. Colon cleansing is achieved with a combination of Pico-salax and bisacodyl. Safety, specifically effects on hemodynamics and electrolytes, is assessed at screening, immediately prior to colonoscopy, and 24-hours post colonoscopy. Efficacy is assessed using both the Ottawa and Aronchick bowel preparation scales which allows for further comparison of these scales. Patient tolerance is assessed using a questionnaire to evaluate the ease of completion, taste, and side effects. A total of 50 patients will be assessed to ensure an adequate distribution of samples.
Results: Preliminary results in a limited number of patients (n=8) demonstrate that changes in mean electrolytes are minimal. Mean values pre-preparation, post-preparation, and 24 hours post-preparation include sodium (141, 137, 137 mmol/L), potassium (4.1, 3.6, 3.7 mmol/L), ionized calcium (1.22, 1.22, 1.23 mmol/L), magnesium (0.94, 0.97, 0.95 mmol/L), and phosphate (0.94, 1.13, 1.07 mmol/L). None of these changes resulted in clinical sequelae. Three of 4 patients had excellent or good preparations and 1 patient had a poor or fair preparation as rated by both the Ottawa and Aronchick scales. The majority of patients rated their preparation as very easy to take.
Conclusions: To date we have found only minimal changes in electrolytes after colon cleansing with Pico-salax. Any changes observed begin to return to baseline within 24 hours. The majority of patients have had excellent or good bowel cleansing and have rated the preparation as very easy to take. In appropriately screened elderly patients Pico-salax appears to be safe and effective.