Premedication Dyclonine Improves Visibility During Bowel Cleansing for Colonoscopy
Trial Snapshot
- Phase
- Phase 4
- Sponsor
- Changhai Hospital
- Enrollment
- 580
- Locations
- 1
- Primary Endpoint
- the amount of air bubbles
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Screening
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
3L PEG
only used 3L PEG
Intervention: 3L PEG (Drug)
3L PEG+Dyclonine Hydrochloride Mucilage
used 3L PEG+Dyclonine Hydrochloride Mucilage
Intervention: 3L PEG+Dyclonine Hydrochloride Mucilage (Drug)
Outcomes
Primary Outcomes
the amount of air bubbles
Time Frame: 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 Outcomes
- adenoma detection rate(2 days)
- mean total adenomas detected beyond first(2 days)
Investigators
Zhaoshen Li
Director, Head of Department of Gastroenterology, Principal Investigator, Clinical Professor
Changhai Hospital