Comparing Single-dose Low-volume PEG Plus Bisacodyl vs. Split-dose PEG for Bowel Preparation in Morning Colonoscopy

Study Overview
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Brief Summary
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Colonoscopy is the best method to detect colorectal cancer and colonic polyps. Studies showed that adenoma detection rate positive correlation with good bowel preparation which makes bowel preparation an important issue. Hence, investigators conduct a clinical trial about adding another laxative agent to morning single dose low-volume PEG. To see if this new regimen could have non-inferior efficacy and lower life/sleep impact compared with standard regimen.

Detailed Description
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Colorectal cancer incidence rate has increased in recently years, and colorectal cancer has come to the top of cancer incidence ranking of Taiwan. Colonoscopy is the best method to detect colorectal cancer and colonic polyps. Studies showed that adenoma detection rate positive correlation with good bowel preparation. That makes bowel preparation an important issue. Polyethylene Glycol (PEG) is widely used for bowel preparation for it efficacy and safety. However, there are many different adjunctive, dose, timing of administration in PEG preparation. Some may decrease patient tolerability due to large fluid volume, and some may influence patient's life and sleep quality when performing bowel preparation. Here, investigators conduct a clinical trial about adding another laxative agent to morning single dose low-volume PEG. To see if this new regimen could have non-inferior efficacy and lower life/sleep impact compared with standard regimen.

Official Title
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Comparison of Single-dose (Morning) Low-volume Polyethylene Glycol Plus Bisacodyl Versus Split-dose Polyethylene Glycol for Bowel Preparation Efficacy in Patient Receiving Morning Colonoscopy

Conditions
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Bowel Preparation

Intervention / Treatment
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* Drug: Polyethylene glycol and bisacodyl
* Drug: Split-dose polyethylene glycol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 20-70 years. Out-patient department ambulatory patient. Patients who have indications to receive colonoscopy. Exclusion Criteria: Age is under 20 or over 70 Have severe renal impairment (hemodialysis or eGFR<30). Have severe congestive heart failure (NYHAⅢorⅣ). Pregnant or lactating, or women is under oral contraceptive. Have history of bowel obstruction or resection, known or suspected gastroparesis acute gastric/intestinal ulcer, toxic colitis or megacolon Be allergic to polyethylene glycol (PEG) or bisacodyl. Have severe constipation ( ≤ 1 bowel movement per week). Patient who has Phenylketonuria. Refuse to sign consent to the study.

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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No

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: Polyethylene glycol and bisacodyl<br>In order to decrease the dose and frequency of polyethylene glycol, we added bisacodyl at the night before examination to facilitate the action of polyethylene glycol given solely in the morning of examination. | Drug: Polyethylene glycol and bisacodyl<br>* Intervention: Take 3 tablets (15mg) of stimulant laxatives Dulcolax® (bisacodyl) at 10pm the day before examination. Take two pack of osmotic laxative Klean-prep® powder (Polyethylene glycol) mixed with 2000ml water at 5am on the morning of examination.<br>* Other names: Klean-prep®;|
| Active Comparator: Split-dose polyethylene glycol<br>The standard regimen of polyethylene glycol was used in this group. The participant of this arm receives polyethylene glycol in the evening before examination and the morning of examination . | Drug: Split-dose polyethylene glycol<br>* Take two pack of Klean-prep® powder mixed with 2000ml water at 6pm before the day of examination, and take another two pack of osmotic laxative Klean-prep® powder mixed with 2000ml water at 5am on the examination day.<br>* Other names: Klean-prep®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Ottawa Bowel Preparation Scale | Examiner will fill a case report form out after performing a colonoscopy. Score below or equal to 6 will be classified as good preparation. | Within 24 hours after colonoscopy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Life disturbance | Evaluate patients life disturbance with a questionnaire before performing a colonoscopy. The questionnaire including side effect, sleep quality, interference of life/work, and tendency of same bowel preparation method at next colonoscopy. | 30 minutes before patient receive colonoscopy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Polyethylene Glycol, Bisacodyl, Colonoscopy, Bowel preparation, Ottawa bowel preparation scale