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Clinical Trials/NCT03352700
NCT03352700
Unknown
Phase 4

Premedication Dyclonine Improves Visibility During Bowel Cleansing for Colonoscopy

Changhai Hospital1 site in 1 country580 target enrollmentDecember 1, 2017

Overview

Phase
Phase 4
Intervention
3L PEG
Conditions
Bowel Preparation Scale
Sponsor
Changhai Hospital
Enrollment
580
Locations
1
Primary Endpoint
the amount of air bubbles
Last Updated
8 years ago

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.

Registry
clinicaltrials.gov
Start Date
December 1, 2017
End Date
February 1, 2018
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Zhaoshen Li

Director, Head of Department of Gastroenterology, Principal Investigator, Clinical Professor

Changhai Hospital

Eligibility Criteria

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

3L PEG+Dyclonine Hydrochloride Mucilage

used 3L PEG+Dyclonine Hydrochloride Mucilage

Intervention: 3L PEG+Dyclonine Hydrochloride Mucilage

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)

Study Sites (1)

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