Colon Prep Update: 2015 Let’s be clear Harish K Gagneja, MD, AGAF, FACG, FASGE President, TSGE President, Austin Gastroenterology, P.A. www.austingastro.com

“The colonoscopy was a great experience except for the horrible bowel prep. There has to be an easier way to get cleaned out, doc!!”

A cleanly prepped colon is a critical component of a successful colonoscopy

Colon Prep

Oh no……..

Risk Factors for Poor Prep Male Elderly Higher BMI Unmarried Co-morbities Dementia Sedentary life style Diabetes Opioids use Prior inadequate bowel prep Inpatient status

Bowel Prep is Important!! Inadequate prep leads to Longer procedure time Lower ADR Increased complications Need for repeat examination – cost Over 20 million colonoscopies are performed in US

Focus on Quality Bowel Prep The success of a colonoscopy is closely linked to good bowel preparation, with poor bowel prep often resulting in missed precancerous lesions 40% miss rate for all polyps 27% miss rate large polyps

Focus on Quality Bowel Prep Poor bowel cleansing can result in increased costs related to early repeat procedures. (1% rule: for each 1% of preparations that are inadequate the cost of delivering colonoscopy increases by 1%)

Focus on Quality Bowel Prep The discomfort and inconvenience of bowel preparation affects participation in colonoscopy screening programs The quality of bowel cleansing affects: Cecal intubation rate polyp detection rate Flat polyps detection rate Patients lost to follow up

Focus on Quality Bowel Prep Bowel Prep added to Key Quality measures to be reported Bowel Prep (New) Detection Documentation of cecal intubation Screening & surveillance intervals Up to 20 to 25 percent of all colonoscopies are reported to have an inadequate bowel preparation – target to reduce to less than 15%. (Adequate preparation should be achieved in ≥90% of exams (my opinion)

Ideal Bowel Prep for Colonoscopy Should be Safe Tolerable by the patient Effective to clean the colon and hence improve adenoma detection

Which one is the ideal bowel prep for the colonoscopy?

NONE!!

Preps for Colonoscopy – FDA approved GoLYTELY/NuLYTELY/TriLyte/colyte 4-L PEG 3350 ES HalfLytely - 2L PEG 3350ES/Bisacodyl MoviPrep – 2L PEG 3350 ES/Ascorbic acid SUPREP – Oral sulfate solution Osmoprep – Sodium Phosphate tablets Prepopik – Picosulfate solution

Preps for Colonoscopy – Non-FDA approved MiraLAX and Gatorade mixture MagCitrate combined with Bisacodyl (LoSoPrep) MagCitrate and MiraLAX MiraLAX/Gatorade combined with Bisacodyl Any combination of the above – Really!!

New Considerations in Prep Low pressure intra-colonic water infusion system aka “HyGIeacare”

4-L PEG Solutions PROS - safe, effective especially with split dose CONS – large volume, caution with elderly, nausea, cramps, fullness, bloating and palatability issues for some patients, C/I – GI obstruction, gastric retention, bowel perforation, toxic colitis and toxic maegacolon

HalfLytely PROS – safe, better tolerated than 4L solutions CONS – Less effective than 4L solutions, similar side-effects as with 4L solutions, concerns about Ischemic colitis changes with Bisacodyl use C/I – GI obstruction, gastric retention, bowel perforation, toxic colitis and toxic maegacolon

MoviPrep PROS – safe, better tolerated than 4L solutions (overall volume is 2L prep and 1L clear liquids), effective CONS – Taste, may cause malaise, nausea, abdominal pain and vomiting, serious AEs may occur as a result of electrolyte abnormalities, use with caution in patients with renal dysfunction

SUPREP PROS – Well tolerated due to small volume, effective CONS – Taste, may cause discomfort, abdominal distension, pain, nausea and vomiting, may cause temporary elevations in uric acid, caution in renal disease, expensive with variable insurance coverage

OSMOPREP – “pills” PROS - Well tolerated, effective, better tolerated than the PEG solutions CONS – May cause bloating, abdominal pain, nausea and vomiting, rare reports of phosphate nephrotoxicity (black box warning from the FDA) C/I – Renal disease, cirrhosis, CHF, concomitant use of medications that can affect renal function such as ACEI, diuretics, elderly are at risk for complications

MiraLAX Prep PEG-3350 solution without added electrolytes – not balanced Not FDA approved Pros – Low volume prep (2L), tolerated well (although study comparing the 4L golytely and MiraLAX prep showed no difference in tolerability)* Cons – Electrolyte disturbances especially hyponatremia has been reported, inferior to 4L PEG solution when used as split dose. ** *Enestvedt BK, et al. Aliment Pharmacol Ther. 2011;33(1):33-40 **Hjelkrem M, et al. Clin Gastroenterol Hepatol. 2011;9(4):326-332.

Comparison of Different Preps Purgative Number of Trials ITT Patients OR (95% CI) PEG split HD PEG split LD 6 1,305 1.89 (1.01-3.46) PEG split vs NaP split 1 218 0.35 (-0.15-0.85) PEG split vs PICO split 89 6.32 (1.30-30.81) PEG split vs OSS split 379 1.07 (0.50-2.29) NaP split vs PICO split 372 1.15 (0.49-2.67) Menard et al, GIE, 2014

Miralax/Gatorade Prep Patients like this Physicians use it frequently Siddiqui et al 2014, 5 trials, 1960-2014 Adequate prep 0.65 (0.4-0.98) ADR NS Side effects NS Willingness to repeat 7.3 (4.9-11.0) Multiple case reports of hyponatremia, not FDA approved

Timing of Prep Day before Split dose Same day prep

Split Dose Prep : Efficacy Author Timeframe No. of Trials Efficacy/OR Kilgore 2011 1960-2011 5 3.7 (2.8-4.9) Enestvedt 2012 9 3.5 (2.5-4.9) Bucci 2014 1960-2013 29 85% vs 63% Martel 2015 1980-2014 47 2.5 (1.9-3.4)

Split Dose Prep – Patient Considerations Well accepted Increased compliance (94% vs 84%) Willingness to repeat (OR 1.8-1.9)

The Split-Dose Difference

Split Dose Prep: ADR Martel et al 2015, meta-analysis 47 trials OR 1.5 (0.7-3.3)

Split Dose Prep is the standard of care in 2015

Same Day Prep for PM cases Author No. of Patients Comparison Adequacy of Prep P-value Church 1998 317 AM vs PM 90% vs 73% <0.01 Varughesa 2010 136 4.7 vs 7.1 Ottawa scale Matro 2010 116 AM vs PM/AM 92% vs 94% 0.01* *non-inferior Longcroft 2012 227 98% vs 90%

Low Pressure Intra-colonic water infusion system

Low Pressure Intra-colonic water infusion system Prep Tech introduces lubricated, sterile disposable nozzle into the rectum. Gentle stream of temperature controlled gravity-flow water loosens stool and induces peristalsis for natural evacuation of the colon. Patient evacuates bowel and urinates freely and naturally throughout the procedure. Prep is complete when clear water exits the body and the trained practitioner determines that patient has completed all phases of cleansing (usually less than one hour).

Low Pressure Intra-colonic water infusion system – Safety Features Stringent validated disinfection protocol Rectal nozzle is gently arched and ergonomic, with a diameter of less than 1 cm. Water flows through both a sediment and UV filter. Temperature of the water is steadily maintained in the safe range between 37-39° C as set by the operator. Water automatically stops flowing to the patient should the temperature go above 39° C. Water pressure is maintained at approximately 1 psi (well below the 2 psi limit the large intestine can safely tolerate

Low Pressure Intra-colonic water infusion system - AG Experience

ADR: AG vs National Average 25% 18% 6 minutes Austin Gastro 39% 27% 9 minutes ADR-Male ADR-Female W/D Time

Low Residue Diet and Prep Clear liquids versus low residue diet Gut activity, stimulated by food DDW 2015, abstract, Nguyen et al 5 studies, meta-analysis OR 3.2 (2.0-5.3)

Adjuncts to Preparation Simethicone Bisacodyl Lubiprostone Prokinetics Lopermide Probiotics Olive oil

Patient Education Patient must be engaged Written instructions +/- visual aids - works Educational booklet – better prep YouTube videos – increased ADR Smartphone Apps – not widely used

Conclusions Split the dose Consider low residue diet Patient education Shoot for 4 hr runway time Consider low residue diet Non-inferior cleaning Increased tolerability Patient education

Thank You