The Effects of An Addition of Water Enema to PEG for Colon Preparation

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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The Effects of An Addition of Water Enema to PEG for Colon Preparation: A Randomized Controlled Trial

Conditions
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Adenoma, Bile Duct

Intervention / Treatment
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* Procedure: Water enema


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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
Interventional 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: No enema group<br>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. | Procedure: Water enema<br>* Addition of water enema in standard PEG preparation in participants scheduled for CRC screening.<br>|
| Active Comparator: Water enema group<br>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. | Procedure: Water enema<br>* Addition of water enema in standard PEG preparation in participants scheduled for CRC screening.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bowel preparation, CRC screening