Comparison of Low-volume PEG Plus Ascorbic Acid Versus Standard PEG Solution as Bowel Cleansing for Colonoscopy

Study Overview
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Brief Summary
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The purpose of this study is to compare two regimens of low volume (2L) polyethylene glycol(PEG)plus ascorbic acid versus standard volume (4L) PEG alone for bowel preparation in out-patients

Detailed Description
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Inadequate bowel preparation may lead to a longer colonoscopy, and to an inability to identify lesions. PEG can provide a rapid orthograde peroral approach to colonic lavage without producing significant fluid or electrolyte changes. Thus PEG is now commonly used for bowel preparation. However, large amounts and unsatisfactory taste of PEG solution are generally poorly tolerated. a new low volume PEG-based bowel cleansing agents became available at foreign countries. Although several studies reported the efficacy and improved compliance of these low volume PEG plus ascorbic acid solution for colonoscopy, but result in Korean patients was not-recognized.

Official Title
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Randomized Controlled Trial of Low-volume PEG Plus Ascorbic Acid Versus Standard PEG Solution as Bowel Cleansing for Colonoscopy

Conditions
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Colonoscopy [E01.370.372.250.250.200]

Intervention / Treatment
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* Drug: polyethylene glycol, ascorbic acid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Out-patients for colonoscopy Exclusion Criteria: age under 19 years or over 80 years Intestinal obstruction Women of pregnant, breastfeeding, or at risk of becoming pregnant major psychiatric illness known allergy to PEG serious condition- severe cardiac, renal, or metabolic diseases past history of colon resection current acute exacerbation of chronic inflammatory bowel disease functional constipation defined by Rome III diagnostic criteria

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 80 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| PEG + ascorbic acid<br>Those who taken PEG 2L + ascorbic acid | Drug: polyethylene glycol, ascorbic acid<br>* comparison of different solutions for bowel preparation<br>|
| PEG 4L<br>Those who taken PEG 4L alone | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The efficacy of bowel preparation | three segmental preparation scoring (0 4, Rt., mid, Lt.colon) total preparation grade:A,B,C,D (A or B was defined successful bowel cleansing) Influence of the intake of additional fluid in PEG+ascorbic acid | one day (after colonoscopy) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient's compliance and acceptability | satisfaction (Visual Analogue Scale) amount of ingestion, frequency and amount of vomiting, tolerability, complication, taste | one day (after injestion of preparation solution) |