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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 3L PEG | Placebo Comparator | only used 3L PEG |
|
| 3L PEG+Dyclonine Hydrochloride Mucilage | Experimental | used 3L PEG+Dyclonine Hydrochloride Mucilage |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 3L PEG | Drug | Group A patients (n = 300) used only 3L PEG before colonoscopy. |
| |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhaosheng Li, MD | Contact | +86-21-31161335 | zhaoshenlismmu@gmail.com | |
| Yu Bai | Contact | +86-13564665324 | baiyu1998@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Peng Cheng | Changhai Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Changhai Hospital, Second Military Medical University | Shanghai | 200433 | China |
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| 3L PEG+Dyclonine Hydrochloride Mucilage |
| Drug |
Patients in group B (n = 300) were additionally advised to Dyclonine Hydrochloride Mucilage plus 3 L PEG |
|
| 2 days |