Bowel Preparation Scale, the Amount of Air Bubble, Adenoma Detection Rate
Conditions
Brief summary
To evaluate the efficacy, visibility of low volume polyethyleneglycol-simeticone (2-LPEG-S) for colonoscopy.
Detailed description
In this randomized controlled study, consecutive outpatients scheduled for elective colonoscopy were randomized into two groups. Group A patients (n = 300) used only 2 L PEG before colonoscopy. Patients in group B (n = 300) were additionally advised to simeticone plus 2 L 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
DRUG2L PEG
DRUG2L PEG+simethicone
Sponsors
First Affiliated Hospital of Zhejiang University
Sir Run Run Shaw Hospital
Tongji Hospital
Qilu Hospital of Shandong University
Zhongda Hospital
Jinan Military General Hospital
First Hospital of China Medical University
Changhai Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Patients are between 18-65 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| adenoma detection rate | 2 days | — |
| bowel preparation scale | 2 days | — |
| the amount of air bubbles | 2 days | Five areas of the colon (rectosigmoid, descending, transverse, ascending, and cecum) were graded for 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. |
Countries
China
Outcome results
None listed