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What is the safest and most effective colon cleansing preparation?

Ambulatory Endoscopy Clinic Day. What is the safest and most effective colon cleansing preparation?. Dr. Stephen Vanner. Conflict of Interest Declaration:. Unrestricted funding from C.B. Fleet Co, Pharma Science, Ferring Canada to support clinical studies

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What is the safest and most effective colon cleansing preparation?

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  1. Ambulatory Endoscopy Clinic Day What is the safest and most effective colon cleansing preparation? Dr. Stephen Vanner

  2. Conflict of Interest Declaration: • Unrestricted funding from C.B. Fleet Co, Pharma Science, Ferring Canada to support clinical studies • Speakers bureau C.B. Fleet Co. and Ferring Canada • Consultant Ferring US • Patent on oral rehydration solutions with NaP

  3. Survey of Current Colon Cleansing Use in Ambulatory Clinics in Ontario

  4. Objectives • Where are we and what have we learned • The case for stimulant laxatives as an adjunct • Fine tuning the colon cleansing regimen

  5. Components of the Optimum Preparation in 2006 Hookey and Vanner CJG 2007

  6. Can we enhance the efficacy of Pico-salax without compromising tolerability and safety ? Lawrence Hookey and Stephen Vanner GI Diseases Research Unit

  7. Hypothesis • Bisacodyl 10 mg taken for two nights before picosalax combined with oral rehydration will increase efficacy and not compromise tolerability or safety • Picosalax is a safe agent.

  8. Study Design 120 patients 10 mg bisacodyl Day 3 and day 2 Day 1 A sachet PCSLX +Gatorade 120 patients A sachet PCSLX 5 and 10 PM + Gatorade 120 patients 45 ml NaP 5 and 10 PM + Gatorade

  9. Efficacy Validated Ottawa Bowel Score Score 0-14 validated instrument Colonscopists trained and anchors posted in endoscopy suite

  10. Ottawa Bowel Preparation Scale

  11. % Patients with Colons Scored as Poor or Inadequate Preparation

  12. Percent of colonoscopies having small, moderate, or large amount of luminal fluid * * P = 0.0015 compared to Pico and Pico + Bisacodyl

  13. Patient Tolerability • 5 point Likert scale • Overall tolerability • 5 symptoms

  14. Patient Global Rating of Ease of Taking Preparation

  15. Patient Ratings of Taste and Nausea

  16. Safety • Postural vitals in clinic and morning of procedure • Baseline Hematocrit, Cr,/BUN, Electrolytes, Ca2+, P04-, Mg2+, estimated GFR and morning of procedure

  17. Hemodynamic/Volume Status

  18. Electrolytes

  19. Summary • Piocsalax is much better tolerated than oral NaP and Colyte • Picosalax plus bisacodyl provides a very favourable colon cleansing regimen • Picosalax is safe and lacks the safety issues associated with oral Na P Hookey and Vanner AJG 2009

  20. Fine Tuning the Optimal Cleansing Regimen

  21. Bowel response to Pico-Salax/Bisacodyl Vanner Hookey 2009

  22. * Bowel Habit and colon cleansing P=0.16

  23. Bowel habit and colon cleansing by preparation Pico plus may be advantageous in constipation P>0.2

  24. * Time of colonoscopy and colon cleansing P<0.01

  25. Split Dosing Enhances Cleansing after 11 am <11 am >11 am <11 am >11 am

  26. Number of Doses “ if 2 sachets are good 4 must be better ”

  27. Metabolic Evaluation Rahman Hookey Vanner 2009

  28. There was an increase in QTc intervals from time 0, 12, and 24 hours which were 404, 415 and 420 with a statistically significant increase from time 0 compared to time 24 hours (p<0.05). There was an increase in QTc intervals from time 0, 12, and 24 hours which were 404, 415 and 420 with a statistically significant increase from time 0 compared to time 24 hours (p<0.05). There was an increase in QTc intervals from time 0, 12, and 24 hours which were 404, 415 and 420 with a statistically significant increase from time 0 compared to time 24 hours (p<0.05). There was an increase in QTc intervals from time 0, 12, and 24 hours which were 404, 415 and 420 with a statistically significant increase from time 0 compared to time 24 hours (p<0.05). There was an increase in QTc intervals from time 0, 12, and 24 hours which were 404, 415 and 420 with a statistically significant increase from time 0 compared to time 24 hours (p<0.05).

  29. Serial Assessment > 70 years Fowler Hookey Vanner 2009 • Baseline Day 1 Day 2 • Na+ 133 118 122 133 • Na+ 133 129 130 70 yr male, ASA Plavix ACE Avandia 84 yr female

  30. Rehydration with Gatorade Hypothesis: supplementation with oral carbohydrate-electrolyte rehydration solution (Gatorade) will improve hemodynamic status of patients receiving NaP intravascular space enterocyte lumen Na+ glucose H20 Barclay, R., Depew, W., and Vanner, S. GI Endoscopy 56:633, 2002.

  31. Results -- Quality of Bowel Preparation p = 0.0056for overall trend

  32. What preparation is your patient taking? • Picosalax • Picodan • Purgodan Picosalax = Picodan = Purgodan ???

  33. Which instructions did the patient follow?????

  34. Conclusions • Picosalax plus bisacodyl 10 mg for two nights prior a provides a very favourable cleansing regimen • Hydration important : Before - Oral rehydration solution or clear liquids important; During – IV saline; After – push oral fluids • Safety profile appears excellent but we still need to be careful, avoid in renal failure and bowel obstruction • Split dose likely enhances efficacy and instructions are very important

  35. Effect of “Split Dosing” of PEG and NaP on Efficacy

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