Premedication Dyclonine Improves Visibility During Bowel Cleansing for Colonoscopy

Study Overview
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Brief Summary
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In this randomized controlled study, consecutive outpatients scheduled for elective colonoscopy were randomized into two groups. Group A patients (n = 300) used only 3L PEG before colonoscopy. Patients in group B (n = 300) were additionally advised to Dyclonine Hydrochloride Mucilage plus 3L PEG, The overall quality of colonoscopy cleaning was evaluated using the Boston Bowel Preparation Scale by a single endoscopist who was blinded to the intervention. Visibility was blindly assessed for the amount of air bubbles and adenoma detection rate (ADR). Difficulty of procedure, and adverse events were also evaluated.

Official Title
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Premedication Dyclonine Improves Visibility During Bowel Cleansing for Colonoscopy

Conditions
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Bowel Preparation Scale, the Amount of Air Bubble, Adenoma Detection Rate

Intervention / Treatment
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* Drug: 3L PEG
* Drug: 3L PEG+Dyclonine Hydrochloride Mucilage


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients are between 18-75 years old undergoing colonoscopy for diagnostic investigation, colorectal cancer screening or follow-up Exclusion Criteria: suspected gastrointestinal obstruction or perforation severe acute inflammatory bowel disease toxic megacolon ileus or gastric retention, ileostomy, hypersensitivity to any of the ingredients pregnancy and lactation and/or at a risk of becoming pregnant

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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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 3L PEG<br>only used 3L PEG | Drug: 3L PEG<br>* Group A patients (n = 300) used only 3L PEG before colonoscopy.<br>|
| Experimental: 3L PEG+Dyclonine Hydrochloride Mucilage<br>used 3L PEG+Dyclonine Hydrochloride Mucilage | Drug: 3L PEG+Dyclonine Hydrochloride Mucilage<br>* Patients in group B (n = 300) were additionally advised to Dyclonine Hydrochloride Mucilage plus 3 L PEG<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the amount of air bubbles | The amount of intraluminal air bubbles was classified into four grades as shown below: Grade 0 = No or minimal scattered bubbles; Grade 1 = Bubbles covering at least half the luminal diameter; Grade 2 = Bubbles covering the circumference of the lumen; Grade 3 = Bubbles filling the entire lumen. Bubbles filling the entire lumen. | 2 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| adenoma detection rate | The secondary end point of the study included adenoma detection rate | 2 days | 
| mean total adenomas detected beyond first | It was a new metric called ADR-Plus, the mean number of incremental adenomas after the fist. | 2 days |