Premedication Dyclonine Improves Visibility During Bowel Cleansing for Colonoscopy
1 other identifier
interventional
580
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Dec 2017
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 21, 2017
CompletedFirst Posted
Study publicly available on registry
November 24, 2017
CompletedStudy Start
First participant enrolled
December 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2018
CompletedNovember 24, 2017
November 1, 2017
1 month
November 21, 2017
November 21, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (2)
adenoma detection rate
2 days
mean total adenomas detected beyond first
2 days
Study Arms (2)
3L PEG
PLACEBO COMPARATORonly used 3L PEG
3L PEG+Dyclonine Hydrochloride Mucilage
EXPERIMENTALused 3L PEG+Dyclonine Hydrochloride Mucilage
Interventions
Patients in group B (n = 300) were additionally advised to Dyclonine Hydrochloride Mucilage plus 3 L PEG
Eligibility Criteria
You may qualify if:
- Patients are between 18-75 years old
- undergoing colonoscopy for diagnostic investigation, colorectal cancer screening or follow-up
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Changhai Hospital, Second Military Medical University
Shanghai, 200433, China
Study Officials
- PRINCIPAL INVESTIGATOR
Peng Cheng
Changhai Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director, Head of Department of Gastroenterology, Principal Investigator, Clinical Professor
Study Record Dates
First Submitted
November 21, 2017
First Posted
November 24, 2017
Study Start
December 1, 2017
Primary Completion
January 1, 2018
Study Completion
February 1, 2018
Last Updated
November 24, 2017
Record last verified: 2017-11