Colon Prep Update: 2015 Let’s be clear Harish K Gagneja, MD, AGAF, FACG, FASGE President, TSGE...

Colon Prep Update: 2015 Colon Prep Update: 2015 Let’s be clearLet’s be clear

Harish K Gagneja, MD, AGAF, FACG, FASGEPresident, 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 Ideal Bowel Prep for ColonoscopyColonoscopy

• Should beSafe

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 Preps for Colonoscopy – FDA approvedapproved

• 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 Solutions4-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

HalfLytelyHalfLytely

• 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

MoviPrepMoviPrep

• 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

SUPREPSUPREP

• 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”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 PrepMiraLAX 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 HDPEG 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

1 89 6.32 (1.30-30.81)

PEG split vs OSS split 1 379 1.07 (0.50-2.29)

NaP split vs PICO split 1 372 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 1960-2011 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 DifferenceThe 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 AM vs PM 4.7 vs 7.1 Ottawa scale

<0.01

Matro 2010 116 AM vs PM/AM 92% vs 94% 0.01**non-inferior

Longcroft 2012 227 AM vs PM/AM 98% vs 90% <0.01

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 AverageADR: AG vs National Average

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– Shoot for 4 hr runway time

• Consider low residue diet – Non-inferior cleaning– Increased tolerability

• Patient education

Thank You