The Impact of Additional Oral Preparation on the Quality of Bowel Preparation for Colonoscopy

Study Overview
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Brief Summary
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Although adequate bowel preparation is essential for successful colonoscopy, the 23% of patients had shown inadequate bowel preparation. Inadequate bowel preparation may results in incomplete examination, increased patient's discomfort, decreased polyp detection rates, ultimately leading to repeated colonoscopies. One prior study showed that patients reporting their last rectal effluents as brown color or solid stool had a 54% chance of having fair or poor preparation. Thus, recent consensus guideline suggested consideration of additional oral preparation in patients presenting brown effluents on the day of colonoscopy. However, the data supporting additional oral preparation is still spares. Therefore, the investigators aimed to examine the impact of additional oral preparation on the quality of bowel preparation for colonoscopy in patients showing brown effluents on the day of colonoscopy.

Official Title
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The Impact of Additional Oral Preparation on the Quality of Bowel Preparation for Colonoscopy in Patients Showing Brown Effluents

Conditions
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Bowel Preparation Quality

Intervention / Treatment
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* Drug: Additional oral preparation (3L of PEG+Asc, Coolprep®)
* Drug: Standard oral preparation (2L of PEG+Asc, Coolprep®)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients who reporting their last rectal effluents as brown color or solid stool on the day colonoscopy Exclusion Criteria: known hypersensitivity to polyethylene glycol severe congestive heart failure [New York Heart Association (NYHA) grade III or grade IV] severe renal insufficiency (creatinine clearance <30 ml/min) hemodynamic instability suspected intestinal obstruction or perforation compromised swallowing reflex or altered mental status pregnancy or lactating woman patients who declined to participate

Ages Eligible for Study
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Minimum Age: 18 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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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Additional oral preparation<br>The investigational or experimental arm will receive standard oral preparation plus additional oral preparation (1l of polyethylene glycol (PEG)+ascorbic acid (Asc)) for colonoscopy. * Compositions/1L : Sodium Chloride 2.691g Potassium Chloride 1.015g Anhydrous sodium sulfate 7.5g PEG 3350 100g ascorbic acid 4.7g sodium ascorbate 5.9g | Drug: Additional oral preparation (3L of PEG+Asc, Coolprep®)<br>* The interventional or experimental arm will receive 1l of additional PEG+Asc, Coolprep® on the day of colonoscopy * Compositions/1L : Sodium Chloride 2.691g Potassium Chloride 1.015g Anhydrous sodium sulfate 7.5g PEG 3350 100g ascorbic acid 4.7g sodium ascorbate 5.9g<br>* Other names: Coolprep® (TaeJoon Pharmaceuticals, Seoul, Korea):3L;|
| Active Comparator: Standard oral preparation<br>The control arm will receive currently used oral preparation (2L of polyethylene glycol+ascorbic acid) for colonoscopy. * Compositions/1L : Sodium Chloride 2.691g Potassium Chloride 1.015g Anhydrous sodium sulfate 7.5g PEG 3350 100g ascorbic acid 4.7g sodium ascorbate 5.9g | Drug: Standard oral preparation (2L of PEG+Asc, Coolprep®)<br>* The control arm will receive currently used oral preparation (2l of PEG+Asc, Coolprep®) for colonoscopy * Compositions/1L : Sodium Chloride 2.691g Potassium Chloride 1.015g Anhydrous sodium sulfate 7.5g PEG 3350 100g ascorbic acid 4.7g sodium ascorbate 5.9g<br>* Other names: Coolprep® (TaeJoon Pharmaceuticals, Seoul, Korea) : 2L;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of bowel preparation | The primary outcome will be the endoscopist's assessment of the quality of preparation using a standardized bowel preparation scale | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adenoma detection rate | Number of adenomatous polyps | Day 1 | 
| Patient compliance | Patient compliance with preparation instructions self-reported in a pre-procedure questionnaire | Baseline | 
| Patient satisfaction | Patient's perception of the preparation method as self-reported on a pre-procedure questionnaire. | Baseline |