Adenoma, Bile Duct
Conditions
Keywords
Bowel preparation, CRC screening
Brief summary
The purpose of this study is to compare the preparation quality by using Ottawa Bowel Preparation Scale between the standard PEG preparation and the addition of water enema in participants scheduled for CRC screening
Detailed description
Background : Good bowel preparation improves the rate of polyp detection and the time of caecal intubation during colorectal cancer (CRC) screening. Suboptimal bowel preparation can results in adenoma miss rate up to 42% (95% CI, 35-49) and advanced adenoma miss rate up to 27% (95% CI, 17-41) The European Society of Gastrointestinal Endoscopy (ESGE) Guideline recommends a split regimen of 4L of polyethylene glycol (PEG) solution (or a same-day regimen in the case of afternoon colonoscopy) for a routine bowel preparation and the delay between the last dose of bowel preparation and colonoscopy should be minimized and no longer than 4 hours. The investigators hypothesize that the addition of water enema to the standard PEG bowel preparation could provide the better quality of bowel preparation and then result in improvement in the rate of adenoma detection among participants scheduled for CRC screening with preparation to procedure interval \> 8 hr. The purpose of this study is to compare the preparation quality using Ottawa Bowel Preparation Scale between the standard PEG preparation and the addition of water enema in participants scheduled for CRC screening. The secondary aim is to compare the effect of the standard PEG bowel preparation and the addition of water enema in terms of adenoma detection rate, the completeness of the examination, total and withdrawal time, safety and adverse events among those scheduled for CRC screening.
Interventions
PROCEDUREWater enema
Addition of water enema in standard PEG preparation in participants scheduled for CRC screening.
Sponsors
Mahidol University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Investigator)
Intervention model description
In this study, participants will be randomised 1:1 to water enema group or no water enema group using blocked randomization with random block sizes.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* Patients scheduled for CRC screening * Bowel preparation using 3 liters of PEG solution * Colonoscopy performed at 8-16 hours after bowel preparation
Exclusion criteria
* History of a failed bowel preparation * Previous colonic surgery * Uncontrolled underlying disease * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bowel preparation quality using Ottawa Bowel Preparation Scale | 1 days | Evaluate Ottawa Bowel Preparation Scale by 2 endoscopists using video record |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The effect of addition of water enema in standard PEG bowel preparation in terms of adenoma detection rate | 1 days | Evaluate the adenoma detection rate compare between two groups |
| The effect of addition of water enema in the standard PEG bowel preparation in terms of the completeness of the examination | 1 day | Evaluate the completeness of examination compare between two groups |
| The effect of addition of water enema in the standard PEG bowel preparation in terms of total and withdrawal times | 1 day | Evaluate total and withdrawal times of colonoscopy procedures compare between two groups |
| The effect of addition of water enema in the standard PEG bowel preparation in terms of safety and adverse events | 3 days | Evaluate the safety and efficacy of procedures compare between two groups |
Outcome results
None listed