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

Taipei Medical University WanFang Hospital122 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

SINGLE

Enrollment

122

Conditions

Bowel Preparation

Interventions

Polyethylene glycol and bisacodylDRUG

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.

Split-dose polyethylene glycolDRUG

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.

Eligibility

Sex: ALLMin age: 20 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Locations (1)

Wanfang Hospital

Taipei, Taiwan

Outcomes

Primary Outcomes

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".

Time frame: Within 24 hours after colonoscopy

Secondary Outcomes

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.

Time frame: 30 minutes before patient receive colonoscopy

Data from ClinicalTrials.gov

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