Diabetic Colon Preparation Diabetic Colon Preparation for GI Procedurefor GI Procedure

Ann Hayes BSN, RN, CGRNAnn Hayes BSN, RN, CGRNMarti Buffum DNSc, Marti Buffum DNSc, RN, PMHCNS-BCRN, PMHCNS-BC

Joyce Hughes MS, RN, CGRNJoyce Hughes MS, RN, CGRN

Veterans Affairs Medical CenterVeterans Affairs Medical CenterSan FranciscoSan Francisco

BackgroundBackground

Colon cancer second leading cause death Colon cancer second leading cause death from a cancer in North Americafrom a cancer in North America

150,000 colon cancer diagnosed per year150,000 colon cancer diagnosed per year

Totally preventableTotally preventable

ColonoscopyColonoscopy

Increasingly used for screeningIncreasingly used for screening

Adequate bowel prep significant for GI Adequate bowel prep significant for GI units and patientsunits and patients

Clinical ProblemClinical Problem

Inadequate colon preparation means Inadequate colon preparation means repeat procedurerepeat procedure

Colonoscopy has potential risksColonoscopy has potential risks Bleeding and perforationBleeding and perforation Sedation complications:Sedation complications:

• Cardiac Cardiac • respiratoryrespiratory

Required bowel cleansingRequired bowel cleansing

Day prior to procedureDay prior to procedure

Wide variety of colon prepsWide variety of colon preps

Patients often complain about prepPatients often complain about prep

Preventing repeat procedurePreventing repeat procedure

Decreases availability of colon screeningDecreases availability of colon screening

Maximizes patient safetyMaximizes patient safety

Ensures organizational efficiencyEnsures organizational efficiency

Clinical Problem in GI unitClinical Problem in GI unit

1997 Survey of 64 patients colonoscopy 1997 Survey of 64 patients colonoscopy prepspreps

19% had good preps19% had good preps

81% poor prep means repeat exam81% poor prep means repeat exam

GI nursing staff began QI project to GI nursing staff began QI project to improve patient care by improving colon improve patient care by improving colon prepspreps

Nursing Interventions to Improve Nursing Interventions to Improve Colon PrepsColon Preps

Improve patient educationImprove patient education

Phone call week prior to procedurePhone call week prior to procedure

2001 Survey2001 Survey

50 colon preps = 79% good to excellent50 colon preps = 79% good to excellent

But diabetic colon preps = only 63% goodBut diabetic colon preps = only 63% good

New finding!!New finding!!

Prep SurveyPrep Survey

Suggests diabetic patients having more Suggests diabetic patients having more difficulty attaining adequate colon prepdifficulty attaining adequate colon prep

Needs to improve / change the way Needs to improve / change the way diabetic patients are preppeddiabetic patients are prepped

Are diabetics different?Are diabetics different?

Need to do a literature reviewNeed to do a literature review

Found no colon prep studies with diabeticFound no colon prep studies with diabetic

Literature review Literature review

Nakahara et al., (2002) Nakahara et al., (2002) Gastroparesis: slow emptying of stomachGastroparesis: slow emptying of stomach

Well known in medicineWell known in medicine

Causes nausea and often vomitingCauses nausea and often vomiting

Literature Literature

Taylor & Schubert (2001) diabetic patients Taylor & Schubert (2001) diabetic patients prepped significantly less effective prepprepped significantly less effective prep

Using PEG solution for colonoscopyUsing PEG solution for colonoscopy

17 of 45 diabetic patients had inadequate 17 of 45 diabetic patients had inadequate colon prepcolon prep

LiteratureLiterature

Fincher et al (1999) : preps for Fincher et al (1999) : preps for sigmoidoscopy less likely to be adequatesigmoidoscopy less likely to be adequate

Study of 299 Study of 299

Regardless of which 3 preps used, Regardless of which 3 preps used, diabetics less likely to have adequate prepdiabetics less likely to have adequate prep

Literature reviewLiterature review

Study by Maleki et al., (1998): significantly Study by Maleki et al., (1998): significantly slower colonic transit timesslower colonic transit times

Ascending and transverse colon slowerAscending and transverse colon slower

Study by Celik et al., (2001)Study by Celik et al., (2001)

Constipation a problem for 2/3 diabeticsConstipation a problem for 2/3 diabetics

Special Needs of DiabeticSpecial Needs of Diabetic

Approach to colon prep in diabetic patients Approach to colon prep in diabetic patients needs to be different needs to be different

Need to change standard prep usedNeed to change standard prep used

PEG SolutionPEG Solution

Polyethylene glycol-based isotonic salt Polyethylene glycol-based isotonic salt solutionsolution

Davis et, al 1980Davis et, al 1980

Safest and most commonly usedSafest and most commonly used

Sodium Phosphate SolutionSodium Phosphate Solution

Low volume, strong laxativeLow volume, strong laxative

Associated with dangerous fluid & Associated with dangerous fluid & electrolyte shiftselectrolyte shifts

FDA issued a warningFDA issued a warning

Magnesium Citrate (Mg)Magnesium Citrate (Mg)

Study by Berkelhammer 2002 showed Mg Study by Berkelhammer 2002 showed Mg citrate milder, low volume laxativecitrate milder, low volume laxative

Minimizes electrolyte imbalance, Minimizes electrolyte imbalance, dehydration & aphthous ulcersdehydration & aphthous ulcers Sodium phosphate solution = 5.5% ulcersSodium phosphate solution = 5.5% ulcers Mg = 1% ulcersMg = 1% ulcers Significant finding: p< 0.01Significant finding: p< 0.01

Mg CitrateMg Citrate

Aphthous ulcers lead to diagnosis Aphthous ulcers lead to diagnosis confusionconfusion

Could be: IBD, ischemic colitis or infectionCould be: IBD, ischemic colitis or infection

Mg CitrateMg Citrate

Available over the counter & low costAvailable over the counter & low cost

Minimal fluid and electrolyte shiftMinimal fluid and electrolyte shift

Fewer incident aphthous ulcersFewer incident aphthous ulcers

Mg Citrate & ElectrolytesMg Citrate & Electrolytes

Sharma et, al 2001 study showed:Sharma et, al 2001 study showed:

No significant shifts in BP, pulse and No significant shifts in BP, pulse and electrolyteselectrolytes

Mg citrate safe & effective for colon cleansingMg citrate safe & effective for colon cleansing

Usual Reaction to failed Usual Reaction to failed colon prepcolon prep

Repeat colonoscopyRepeat colonoscopy

Double PEG = 8 litersDouble PEG = 8 liters

Double Prep ProblemDouble Prep Problem

Diabetics have slow gastric emptyingDiabetics have slow gastric emptying

Would have difficult consuming large volumesWould have difficult consuming large volumes

Possible vomiting and non adherencePossible vomiting and non adherence

Constipation ProblemConstipation Problem

Large percentage of diabetic are Large percentage of diabetic are constipatedconstipated

Need to correct this prior to starting colon Need to correct this prior to starting colon prepprep

Decision ProcessDecision Process

Conferred with Dr McQuaid, Chief GIDCConferred with Dr McQuaid, Chief GIDC

Tried new prep on small group with good Tried new prep on small group with good successsuccess

Standard Colon PrepStandard Colon Prep

Clear liquids day prior to colonoscopyClear liquids day prior to colonoscopy

Late afternoon:Late afternoon: 10 oz Mg citrate10 oz Mg citrate 4 liters PEG4 liters PEG

New Diabetic Colon PrepNew Diabetic Colon Prep

All patients have clear liquid diet day priorAll patients have clear liquid diet day prior

Diabetics: two days prior to exam 10oz. Diabetics: two days prior to exam 10oz. Mg citrateMg citrate

All patients: day before test, 10oz Mg All patients: day before test, 10oz Mg citrate and 4 liters PEGcitrate and 4 liters PEG

Research QuestionResearch Question

Will new colon prep two 10oz Mg citrate Will new colon prep two 10oz Mg citrate (1 day apart) & 4 liters PEG solution (1 day apart) & 4 liters PEG solution improve diabetic prep over original prep improve diabetic prep over original prep 10oz Mg citrate and 4 liters PEG solution?10oz Mg citrate and 4 liters PEG solution?

MethodMethod

Design: Experimental designDesign: Experimental design

Randomized controlled trialRandomized controlled trial

Double blinded: physician-nurse team and Double blinded: physician-nurse team and patientpatient

Conducted at GIDCConducted at GIDC

University-affiliated VA Medical CenterUniversity-affiliated VA Medical Center

IRB approval form University of California IRB approval form University of California and VA Research Committee and VA Research Committee

200 subjects200 subjects

ProcedureProcedure

ConsentConsent

Randomization: random table of numbersRandomization: random table of numbers

Blinded procedure staffBlinded procedure staff

Patient drinks one of two preps: Patient drinks one of two preps: experimental or standard experimental or standard

InstrumentsInstruments

Demographic InformationDemographic Information AgeAge SexSex Use of narcoticsUse of narcotics Years of being diabeticYears of being diabetic Signs of peripheral or retinal neuropathySigns of peripheral or retinal neuropathy Serum creatinineSerum creatinine

InstrumentsInstruments

Patient QuestionnairePatient Questionnaire Which prep consumed?Which prep consumed? How much was consumed?How much was consumed? How long it took to consume ?How long it took to consume ?

InstrumentsInstruments

Colon cleansing scaleColon cleansing scale Used by GI staff since 1998Used by GI staff since 1998 Adams et al., (1994)Adams et al., (1994) Scale of 1 to 5Scale of 1 to 5

• 1 = very clear of feces1 = very clear of feces• 5 = solid stool, aborted procedure5 = solid stool, aborted procedure• Colon rated at cecum, consensus between nurse Colon rated at cecum, consensus between nurse

and endoscopist and endoscopist

Inclusion Criteria Inclusion Criteria

Outpatient colonoscopyOutpatient colonoscopy DiabeticDiabetic English speakingEnglish speaking

Exclusion CriteriaExclusion Criteria

DementiaDementia PsychosisPsychosis Prior colon surgeryPrior colon surgery

ProceduresProcedures

Recruitment: all diabetic outpatients being Recruitment: all diabetic outpatients being scheduled for colonoscopyscheduled for colonoscopy

Consented patientsConsented patients

Select randomizedSelect randomized envelope (table of envelope (table of random numbers)random numbers)

ProcedureProcedure

Give prep and instructions: standard or Give prep and instructions: standard or experimentalexperimental

All patients received verbal and written All patients received verbal and written instructions from GI RNinstructions from GI RN

ProceduresProcedures Continued Continued

Day of procedure: admitting nurse Day of procedure: admitting nurse completes demographics completes demographics

MD and patient (blinded):MD and patient (blinded):

completed colon prep evaluation during completed colon prep evaluation during colonoscopycolonoscopy

Study Results: DemographicsStudy Results: Demographics

Mean age 62 yearsMean age 62 years Men 187; women 8Men 187; women 8 IDDM = 53; NIDDM = 143IDDM = 53; NIDDM = 143

Demographics not significantly different Demographics not significantly different between the two groupsbetween the two groups

Study ResultsStudy Results

Good colon prep:Good colon prep: Diabetic (experimental) prep = 70% Standard Diabetic (experimental) prep = 70% Standard

prep = 54%prep = 54% Chi-square = 5.14Chi-square = 5.14 P = 0.02P = 0.02

Diabetic patients who used Diabetic prep had Diabetic patients who used Diabetic prep had significantly cleaner colonsignificantly cleaner colon

69.7%

53.5%

40

50

60

70

80

Diabetic Prep

Standard Prep

Chi-square = 5.14, p=0.02

Percent of Patients for Whom Colon was Easily Visualized

Percent of Patients Who Drank 4 Liters of PEG as Directed

91.4% 91.2%

50

60

70

80

90

100

Diabetic Prep

Standard Prep

p=.96, NS

ConclusionConclusion

Diabetic patients having a colonoscopy will Diabetic patients having a colonoscopy will get better colon cleansing if given 10 oz get better colon cleansing if given 10 oz Mg citrate two days prior to procedure Mg citrate two days prior to procedure then 10 oz Mg citrate and 4 liters PEG the then 10 oz Mg citrate and 4 liters PEG the day prior to procedureday prior to procedure

Other GI procedure units could confidently Other GI procedure units could confidently implement this prep for diabetic patientsimplement this prep for diabetic patients

Practice ChangePractice Change

Diabetic prep routinely for all diabetic Diabetic prep routinely for all diabetic patients scheduled for colonoscopypatients scheduled for colonoscopy

Expanding the use of this prep to patients Expanding the use of this prep to patients with constipation and those who had with constipation and those who had inadequately cleans colon on past inadequately cleans colon on past colonoscopy colonoscopy

Diabetes Serious & Common Diabetes Serious & Common Problem in USProblem in US

2008: 8% (24 million)2008: 8% (24 million)

2010 increase to 15%2010 increase to 15%

Veterans 20% in 2000Veterans 20% in 2000

Most are 60 years and olderMost are 60 years and older

Safety of Mg CitrateSafety of Mg Citrate

There were no adverse events in studyThere were no adverse events in study No clinical evidence of:No clinical evidence of:

• HypovolemiaHypovolemia Electrolyte imbalanceElectrolyte imbalance

Patient tolerance to Mg CitratePatient tolerance to Mg Citrate

No patient in study voiced complaintNo patient in study voiced complaint

Flavor toleratedFlavor tolerated ComfortComfort

Significant fewer repeat colonoscopySignificant fewer repeat colonoscopy

Limitations of StudyLimitations of Study

Small number of women in studySmall number of women in study

Question concerning constipation not Question concerning constipation not effectiveeffective

Strengths of StudyStrengths of Study

Large sample sizeLarge sample size

Experimental designExperimental design

Double blindDouble blind

Hence finding are generalizable Hence finding are generalizable

Goal is Clean ColonGoal is Clean Colon

When prepping patient consider:When prepping patient consider: Bowel habitsBowel habits Medical conditionsMedical conditions Difficulty swallowingDifficulty swallowing Lack of mobilityLack of mobility

Above may warrant change is colon prepAbove may warrant change is colon prep

Nursing ResearchNursing Research

Effects the nursing cultureEffects the nursing culture

Nurse involved in research are likely to: Nurse involved in research are likely to: Develop innovationsDevelop innovations Find best practices to improve patient careFind best practices to improve patient care