A Predictive Model for Inadequate Bowel Preparation

Study Overview
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Brief Summary
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We aimed to develop a predictive model of inadequate bowel preparation and to further validate it by a randomized controlled trial.

Official Title
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A Predictive Model for Inadequate Bowel Preparation: Development and Validation With a Randomized Controlled Trial

Conditions
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Bowel Preparation

Intervention / Treatment
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* Drug: Polyethylene Glycol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged 18-75 years undergoing colonoscopy Exclusion Criteria: known or suspected bowel obstruction, stricture or perforation compromised swallowing reflex or mental status severe chronic renal failure(creatinine clearance < 30 ml/min) severe congestive heart failure (New York Heart Association class III or IV) uncontrolled hypertension (systolic blood pressure > 170 mm Hg, diastolic blood pressure > 100 mm Hg) dehydration disturbance of electrolytes pregnancy or lactation hemodynamically unstable unable to give informed consent

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tailored Group<br>In the tailored group, high-risk patients are instructed to drink the first 2 L of Polyethylene Glycol (PEG) at 19:00-21:00 hours on the day before colonoscopy at a rate of 250 ml every 15 min. On the day of the procedure, they take another 2 L PEG 4-6 h before colonoscopy. The low-risk patients were given a standard dose of 2 L PEG 4-6 h before colonoscopy. | Drug: Polyethylene Glycol<br>* In the Tailored group, high-risk people are given intensified bowel preparation regimens, low-risk people are given routine regimens. In the control group, all the patients are given routine regimens.<br>|
| Active Comparator: Control Group<br>In the control group, all the patients drink single dose of 2 l Polyethylene Glycol (PEG) 4-6 h before colonoscopy at a rate of 250 ml every 15 min. | Drug: Polyethylene Glycol<br>* In the Tailored group, high-risk people are given intensified bowel preparation regimens, low-risk people are given routine regimens. In the control group, all the patients are given routine regimens.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Bowel Preparation | The quality of bowel preparation is evaluated using BBPS. | 10 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adenoma Detection Rate | The proportion of patients from whom at least one adenoma can be detected. | 10 months | 
| Polyp Detection Rate | The proportion of patients from whom at least one polyp can be detected. | 10 months | 
| Adverse Events | Including nausea, bloating, stomachache, vomiting, vertigo and belching and so on. | 10 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adenoma, bowel preparation, colonoscopy, predictive model, randomized controlled trial