Bowel Preparation
Conditions
Keywords
Polyethylene Glycol, Bisacodyl, Colonoscopy, Bowel preparation, Ottawa bowel preparation scale
Brief summary
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
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.
Interventions
DRUGPolyethylene glycol and bisacodyl
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.
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.
Sponsors
Taipei Medical University WanFang Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Ottawa Bowel Preparation Scale | Within 24 hours after colonoscopy | Examiner will fill a case report form out after performing a colonoscopy. Score below or equal to 6 will be classified as good preparation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Life disturbance | 30 minutes before patient receive colonoscopy | 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. |
Countries
Taiwan
Outcome results
None listed