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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No enema group | Placebo Comparator | Consecutive participants will be randomly assigned to take a preparation regimen of 3 liter of PEG 8-16 hr. before colonoscopy without water enema. Before the procedure, investigators record baseline parameters. Colonoscopies underwent by experienced endoscopists and by GI fellows. During the colonoscopy, the investigators recorded video, cecal intubation and withdraw time, amount and position of polyps, rate of complete examination and complication. The video was sent to other 2 endoscopists who did not known which participant was enema to evaluate the quality of bowel cleansing by using Ottawa bowel preparation scale and Likert scale for evaluation of side effect, complication during PEG ingestion, enema and colonoscopy, and participant satisfactory. |
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| Water enema group | Active Comparator | Consecutive participants will be randomly assigned to take a preparation regimen of 3 liter of PEG 8-16 hr. before colonoscopy and enema with sterile water until stool was clear or patient felt discomfort but not exceed 3 liter, before colonoscopy. Before the procedure, investigators record baseline parameters. Colonoscopies underwent by experienced endoscopists and by GI fellows. During the colonoscopy, the investigators recorded video, cecal intubation and withdraw time, amount and position of polyps, rate of complete examination and complication.The video was sent to other 2 endoscopists who did not known which participant was enema to evaluate the quality of bowel cleansing by using Ottawa bowel preparation scale and Likert scale. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Water enema | Procedure | Addition of water enema in standard PEG preparation in participants scheduled for CRC screening. |
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| Measure | Description | Time Frame |
|---|---|---|
| Bowel preparation quality using Ottawa Bowel Preparation Scale | Evaluate Ottawa Bowel Preparation Scale by 2 endoscopists using video record | 1 days |
| Measure | Description | Time Frame |
|---|---|---|
| The effect of addition of water enema in standard PEG bowel preparation in terms of adenoma detection rate | Evaluate the adenoma detection rate compare between two groups | 1 days |
| The effect of addition of water enema in the standard PEG bowel preparation in terms of the completeness of the examination |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Somchai Leelakusolvong, M.D. | Mahidol University | Principal Investigator |
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| ID | Term |
|---|---|
| D002759 | Adenoma, Bile Duct |
| ID | Term |
|---|---|
| D000236 | Adenoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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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.
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Evaluate the completeness of examination compare between two groups |
| 1 day |
| The effect of addition of water enema in the standard PEG bowel preparation in terms of total and withdrawal times | Evaluate total and withdrawal times of colonoscopy procedures compare between two groups | 1 day |
| The effect of addition of water enema in the standard PEG bowel preparation in terms of safety and adverse events | Evaluate the safety and efficacy of procedures compare between two groups | 3 days |