Effectiveness of Bisacodyl Suppository Agent for Dose Reduction of Low Dose PEG

Study Overview
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Brief Summary
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Proper bowel cleansing before colonoscopy is an important factor to increase the detection rate of lesions. Low volume polyethylene glycol (PEG) plus ascorbic (PEG-Asc) has reduced the dosage of previous bowel preparation agent, but it still presents discomfort to patients. The aim of this study was to confirm the efficacy and convenience of volume reduction of PEG-Asc by adding bisacodyl suppository at the same day by compared with conventional 2L PEG-Asc.

Detailed Description
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Eligibility criteria: outpatients between the ages of 20 and 70 years, who were scheduled for colonoscopy between August 2017 and January 2018 Exclusion criteria: patients with a history of gastrointestinal tract surgery, inflammatory bowel disease, severe active colitis, underlying chronic kidney disease, or pregnancy. Outcome measures: the Boston Bowel Preparation Scale (BBPS)

Official Title
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Simultaneous Combination of Bisacodyl Suppository Agent and 1L Polyethylene Glycol Plus Ascorbic Acid is Not Inferior and Comfortable Regimen Compared With 2L Polyethylene Glycol Plus Ascorbic Acid: A Randomized Controlled Study

Conditions
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Bowel Preparation

Intervention / Treatment
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* Drug: 2L PEG-Asc
* Drug: Bisacodyl 10Mg Suppository
* Drug: 1L PEG-Asc


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: outpatients who were scheduled for colonoscopy between August 2017 and January 2018 Exclusion Criteria: History of gastrointestinal tract surgery History of inflammatory bowel disease History of severe active colitis History of chronic kidney disease pregnant woman.

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: prospective, randomized, and observer-blind study
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 2L PEG-Asc<br>2L PEG-Asc for bowel preparation | Drug: 2L PEG-Asc<br>* PEG-Asc powder<br>* Other names: coolprep;|
| Active Comparator: 1L PEG-Asc & 'Bisacodyl 10Mg Suppository<br>1L PEG-Asc with 'Bisacodyl 10Mg Suppository for bowel preparation | Drug: Bisacodyl 10Mg Suppository<br>* bisacodyl 10 mg suppository<br>Drug: 1L PEG-Asc<br>* PEG-Asc powder<br>* Other names: coolprep;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Boston Bowel Preparation Scale (BBPS). | 4-point scoring system (0-3) applied to each of the 3 colon segments (right colon including cecum and ascending colon, transverse colon including transverse colon, hepatic and splenic flexure, left colon including descending colon, sigmoid colon, and rectum) | 1 hour |