Combination Method Using Sodium Picosulfate and Magnesium Citrate and PEG With Ascorbic Acid for Bowel Preparation

Study Overview
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Brief Summary
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The aim of this study is to compare the efficacy depending on the order of the sequential combination method using sodium picosulfate and magnesium citrate (PMC) and PEG with ascorbic acid for bowel preparation. The investigators designed this study as a phase II prospective randomized parallel arm clinical trial. 71 participant will be enrolled in each group (142 in total). The primary outcome is the efficacy of bowel preparation. secondary outcomes are tolerability, side effect of the drugs, polyp detection rate and adenoma detection rate.

Official Title
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Comparison the Efficacy Depending on the Order of the Sequential Combination Method Using Sodium Picosulfate and Magnesium Citrate (PMC) and PEG With Ascorbic Acid for Bowel Preparation (The Phase II Prospective Randomized Clinical Trial)

Conditions
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Bowel Preparation, Sodium Picosulfate and Magnesium Citrate, Polyethylene Glycol With Ascorbic Acid

Intervention / Treatment
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* Drug: sodium picosulfate and magnesium citrate, polyethylene glycol with ascorbic acid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age: 20-75 Patients who visited the outpatient clinic for colonoscopy Patients who agreed to participate in this study Exclusion Criteria: pregnancy, breast feeding stage 3-5 chronic kidney disease (glomerular filtration rate < 60 mL/min/1.73m2), inability to maintain adequate fluid intake, pre-existing electrolyte disturbances, symptomatic congestive heart failure, recent (within < 6 months) symptomatic ischemic heart disease (unstable angina or myocardial infarction). toxic megacolon active colitis Allergic to drug altered mental status Nausea and vomiting Hyperphosphatemia glucose-6-phosphate dehydrogenase deficiency Hereditary Phenylketonuria Patients with a history of colon surgery Abdominal operation within 6 months

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PMC/PEG-Asc<br>Picolyte 1 bottle/170cc at one day before colonoscopy, 7 PM. And then, Intake Coolprep 1L at the day of colonoscopy, 5 AM | Drug: sodium picosulfate and magnesium citrate, polyethylene glycol with ascorbic acid<br>* sodium picosulfate and magnesium citrate and 2L polyethylene glycol with ascorbic acid are used as combination method. There is a difference in the order of intake between two group<br>* Other names: Coolprep;|
| Active Comparator: PEG-Asc/PMC<br>Intake Coolprep 1L at one day before colonoscopy, 7 PM. And then, Intake Picolyte 1 bottle/170cc at the day of colonoscopy, 5AM | Drug: sodium picosulfate and magnesium citrate, polyethylene glycol with ascorbic acid<br>* sodium picosulfate and magnesium citrate and 2L polyethylene glycol with ascorbic acid are used as combination method. There is a difference in the order of intake between two group<br>* Other names: Coolprep;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Successful bowel preparation (Excellent and Good in Aronchick bowel preparation score) |  | during colonoscopy |