Bowel Preparation Scale, the Amount of Air Bubble, Adenoma Detection Rate
Conditions
Brief summary
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.
Interventions
DRUG3L PEG
Group A patients (n = 300) used only 3L PEG before colonoscopy.
DRUG3L PEG+Dyclonine Hydrochloride Mucilage
Patients in group B (n = 300) were additionally advised to Dyclonine Hydrochloride Mucilage plus 3 L PEG
Sponsors
Changhai Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
1. Patients are between 18-75 years old 2. undergoing colonoscopy for diagnostic investigation, colorectal cancer screening or follow-up
Exclusion criteria
1. suspected gastrointestinal obstruction or perforation 2. severe acute inflammatory bowel disease 3. toxic megacolon 4. ileus or gastric retention, ileostomy, 5. hypersensitivity to any of the ingredients 6. pregnancy and lactation and/or at a risk of becoming pregnant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the amount of air bubbles | 2 days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| adenoma detection rate | 2 days | The secondary end point of the study included adenoma detection rate |
| mean total adenomas detected beyond first | 2 days | It was a new metric called ADR-Plus, the mean number of incremental adenomas after the fist. |
Countries
China
Contacts
Primary ContactZhaosheng Li, MD
Backup ContactYu Bai
Outcome results
None listed