1. Colonoscopy: Pre-procedure Considerations July, 2013 Paul C. Schroy III, MD, MPH David Lichtenstein MD, and Brian Jacobson MD, MPH Boston Medical Center Boston MA

2. Bowel Preparation

3. Quality of Bowel Prep: Why Does It Matter? Bowel preparation is inadequate in up to 25% of patients undergoing colonoscopy Consequences of inadequate prep: - Increased difficulty of colonoscopy - Prolonged procedure time - Reduced cecal intubation rates - Repeat procedures and shorter surveillance intervals - Reduced Adenoma Detection Rates - Exposure to higher malpractice risk Nelson DB, et al. Gastrointest Endosc 2002;55:307-14 Rex DK, et al. Am J Gastroenterol 2002;97:1696-700 Froehlich F, et al. Gastrointest Endosc 2005;61:378-84 Harewood GC et al. Gastrointest Endosc 2003;58:76-9 3

4. http://phpa.dhmh.maryland.govhttp://phpa.dhmh.maryland.gov July 2013 Prevention and Health Promotion Administration Center for Cancer Prevention and Control Cigarette Restitution Fund Program Negative Consequences of Inadequate Colonoscopy Repeat procedures mean: Additional expenditure by client, insurance, government, and/or programAdditional expenditure by client, insurance, government, and/or program Time lost by client from work and related consequences, for example, lost wagesTime lost by client from work and related consequences, for example, lost wages Additional risk of possible negative side effects from:Additional risk of possible negative side effects from: –repeated bowel preparation (electrolyte imbalance, etc.); or –repeated procedure (bowel perforation, complications from anesthesia, etc.)

5. Types of Bowel Preps Isosmotic full volume Isosmotic low volume Hyper Osmotic 5

6. Isosmotic Full Volume Preps Preparation Active Ingredient Recommended Use Colyte (SchwarzPharm) GoLYTELY (Braintree Lab) NuLYTELY (Braintree Lab) TriLyte (SchwarzPharm) PEG-ELS PEG (sulfate free) 240 mL (8 oz) every 10 min beginning at 5 to 6 pm evening before colonoscopy (total, 4 L); or Split dosing as (3L pm/1L am or 2L pm/2L am) with second dose 3-6 h before procedure) 6

7. Isosmotic Low Volume Preps Preparation Active Ingredient Recommended Use HalfLytely (Braintree Labs) PEG and bisacodyl 2 bisacodyl delayed-release tablets at noon the day before colonoscopy; 240 mL (8 oz) PEG every 10 min at 5 to 6 PM (total, 1 L); Repeat 240 mL (8 oz) every 10 min beginning 3 to 4 h before colon (1 L) Miralax (Schering-Plough) PEG and bisacodyl Mix in Gatorade Instructions same as for halfLytely MoviPrep (Salix) PEG and ascorbic acid 240 mL ( 8 oz) every 15 min at 5 to 6 PM evening before colonoscopy (total, 1 L), followed by at least 16 oz of fluid; 240 mL (8 oz) every 15 min at least 3 to 4 h before colon (1 L) followed by 16 oz fluid 7

8. Hyper Osmotic Preps Preparation Active Ingredient Recommended Use OsmoPrep * (Salix) NaP tablets 20 tablets (4 every 15 min) at 5 to 6 PM the evening before colonoscopy; Repeat with 12 tablets 10 to 12 h later (at least 3 h before colonoscopy) Suprep (Braintree Labs) Na Sulfate 6 oz bottle diluted with 16 oz of water followed by 32 oz water over the next hour ; take the evening before and repeat the morning of colonoscopy Prepopik (Ferring) Na Picosulfate/ Mg citrate Step 1: dissolve 1 packet in 5 oz. og liquid and consume followed by 5, 8 oz glasses of clear liquids at 4 to 6 PM; Step 2: repeat step 1 followed by 3, 8 oz glasses of clear liquids (later that evening, or 4 to 6 hr before procedure) * Black box warning 8

9. Split Dose Preps 9

10. Part (usually ½) of laxative taken the evening prior and remainder a.m. of procedure Colonoscopy should be performed within 8 hours of the last dosing More effective and better tolerated than full dose p.m. Demonstrated superiority –PEG High volume (3L/1L or 2L/2L) Low volume (1L/1L) –Osmotics-NaP, Mg citrate, Na sulfate Recommended in ACG guidelines for CRC screening Rex DK, et al. Am J Gastroenterol. 2009;104:739-75 0. 10

11. PEG (4L) vs. PEG 3350 + Ascorbate (2L+1L H 2 O) Percentage of ALL SEGMENTS being rated Excellent-Good Preps Marmo R et al. Gastrointest Endosc 2010;72:313-20 11

12. Kilgore TW et al. Gastrointest Endosc. 2011;73:1240-45 PEG Split-Dosing: Meta-analysis Split-dose PEG is superior to full-dose PEG with respect to… Satisfactory colon cleansing (OR 3.70; 95% CI, 2.79-4.91;p<0.01) Likelihood of discontinuing prep (OR 0.53; 95% CI, 0.28-0.98;p=0.04) Willingness to repeat same prep (OR 1.76; 95% CI,1.06-2.91;p=0.03) Side effects, e.g., nausea (OR 0.55; 95% CI, 0.38-0.79;p<0.01) 12

13. Timing 13

14. Bowel Preps for Afternoon Colonoscopy: Timing is Everything Patient driven factors (AM better tolerated) –Less interference with day prior work –Lower incidence of prep related symptoms –Superior sleep quality –Dietary restriction? Prep Options –PM only-No! –Split Dosing (PM/AM) or AM only superior Start: within 8 hrs. of colonoscopy End: >2 hrs prior to colonoscopy 14

15. “Good” (Ottawa <2) prep % patients Varughese S et al. Am J Gastroenterol 2010;105:2368-74 Morning Only Prep for PM Colonoscopy 15

16. PM/AM Split-Dosing: What are the Barriers? Patient acceptance of sleep disturbance?Patient acceptance of sleep disturbance? –85% surveyed willing to get up at night to take 2 nd dose –78% complied Bowel activity in transit to procedure “pit stop”?Bowel activity in transit to procedure “pit stop”? –No difference taken PM or SD PM/AM (5-15%) Non-compliance with preprocedure fasting guidelines (increased risk of aspiration)?Non-compliance with preprocedure fasting guidelines (increased risk of aspiration)? –ASA guideline: clears OK 2 hours prior Unger RZ, Rex DK, et al. Dig Dis Sci 2010;55:2030-34 American Society of Anesthesiologists Practice Guidelines for Preoperative Fasting and Pharmacologic Agents to Reduce the Risk of Pulmonary Aspiration. Anesthesiology 2011;114:495-511 Parra-Blanco A et al. World J Gastroenterol 2006;12:6161-6 Khan MA et al. Gastrointest Endosc 2008;67(suppl):AB246 16

17. A.M. versus P.M. Procedures Adenoma Detection Rate (ADR) has been reported higher for morning compared to afternoon colonoscopy –ADR 29.3% in morning vs. 25.3% in afternoon –By multivariate analysis OR 1.2 (95% CI 1.06-1.4,p=0.008) Afternoon colonoscopies have higher failure rates than morning procedures –Incomplete procedure (6.5% vs. 4.1%, OR 1.64, CI 1.11-2.44;p=0.01) –Inadequate prep (15.4% AM vs. 19.7% PM, OR 1.35, CI 1.08-1.69;p=0.01) Sanaka MR et al. Am J Gastroenterol 2006;101:2726-30; Sanaka MR et al. Am J Gastroenterol 2009;104:1659-64 17

18. Fatigue? Confounders? Queue position (i.e. absolute numbers of cases prior) inversely associated with ADR When accounting for full-day vs. half-day blocks, full-day blocks have lower ADRs Adjustment for confounders (e.g. endoscopist, withdrawal time) may account for these observations Regardless, this is measurable and modifiable Lee A, et al. Am J Gastroenterol 2011;106:1457-65; Gurudu SR, et al. Am J Gastroenterol 2011;106:1466-71; Do A, et al. DDW 2012 18

19. Diet

20. Is Dietary Restriction Necessary? Meta-analysis of Split-dosing Kilgore TW et al. Gastrointest Endosc. 2011;73:1240-45 Take Home Message: Optimal preprocedure diet with split-dose regimen not well-defined. Most would consider a clear liquid diet as standard of care. 20

21. High vs. Low Residue Diet Prospective cohort study in Taiwan asked about diet 2 days prior to colonoscopy Low residue = well-cooked meats, eggs, white bread, white rice, pasta, no skins Higher-residue diets were associated with worse bowel preparations Only 44% adhered to low-residue diet Wu et al. Dis Colon Rectum 2011;54:107-12 21

22. How To Predict a Bad Prep: Patient Characteristics Inpatient vs. outpatient (Froehlich et al) Elderly (Froehlich et al) Obesity Lower education History of constipation Use of antidepressants Noncompliance 22

23. How To Deal with a Bad Prep No studies to provide evidence-based guidance Navigator and patient education Extend period of diet modification from 24 to 48h Increase total volume of PEG ( 2 to 4 L, or 4 to 6L) Split dosing Adequate hydration Add Magnesium citrate Add oral bisacodyl or senna 23

24. Bowel Prep is a Quality Indicator High-quality practice should monitor prep quality as a quality indicator Target: 5 mm. Consider practice level interventions if > 10% preps inadequate (e.g., patient education, use of split-dose regimens) Lieberman et al. Gastrointest Endoscopy 2007;65:757-66 24

25. Medications

26. Preprocedure: Anticoagulation Risk of Thromboembolism HighLow Anticoagulation (e.g., warfarin, dabigratran [Pradaxa]) Discontinue warfarin 5 days or dabigratran 1-2 days prior; Consider bridging therapy with heparin or LMWH Discontinue warfarin 5 days or dabigatran 1-2 days prior; Re-institute warfarin after procedure Antiplatelet therapy (e.g., ticlodipine, clopidrogel) Consider discontinuing for 7- 10 days prior Discontinue 7-10 days prior Aspirin/NSAIDsContinue Consider discontinuing 5-7 days prior 26

27. Preprocedure: Diabetic medications Oral Hypoglycemic Agents Insulin Day prior to procedure? Discontinue Take ½ AM dose of isophane insulin (NPH), Lente, Novolin 70/30 or insulin Glargine No regular or insulin lispro Day of procedureDiscontinue Take ½ AM dose of isophane insulin (NPH), Lente, Novolin 70/30 or insulin Glargine Sifri R, et al. Ca Cancer J Clin 2010;60:40-49. 27

28. Preprocedure: Antibiotic prophylaxis Colonoscopy ± polypectomy = low risk procedure Risk of bacteremia < routine daily activities Revised AHA guideline (Wilson W, et al. Circulation 2007:116:1736-54). “Antibiotic prophylaxis to solely prevent infective endocarditis is not recommended for GU or GI procedures” Not recommended for synthetic vascular grafts or orthopedic prostheses. (ASGE. Gastrointest Endosc 2008:67:791-8) 28

29. Preprocedure: Miscellaneous Medications IronDiscontinue 7-10 days prior Opiod analgesics Continue Increase fluid consumption for 1-2 days prior Sifri R, et al. Ca Cancer J Clin 2010;60:40-49. 29

30. Preprocedure: Cardiac Devices Determine the type of cardiac device, indication for the device, the patient’s underlying cardiac rhythm, and degree of pacemaker-dependence before endoscopy Use continuous electrocardiographic rhythm monitoring in addition to pulse oximetry during the procedure. Most patients with cardiac pacemakers may undergo routine uses of electrocautery (eg, polypectomy, hemostasis) with no alterations in management. For patients who are pacemaker dependent and in whom prolonged electrocautery is anticipated consider reprogramming the pacemaker to an asynchronous mode via application of a magnet over the pulse generator during the use of electrocautery. For patients with an implantable cardioverter-defibrillators (ICD) in whom the use of any electrocautery may be anticipated, consultation with a cardiologist or a heart-rhythm specialist is recommended. Deactivation of the ICD function by qualified personnel should be considered. GIE 2007;65;561-8 30