Premedication Dyclonine Improves Visibility During Bowel Cleansing for Colonoscopy
Primary Purpose
Bowel Preparation Scale, the Amount of Air Bubble, Adenoma Detection Rate
Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
3L PEG
3L PEG+Dyclonine Hydrochloride Mucilage
Sponsored by
About this trial
This is an interventional screening trial for Bowel Preparation Scale
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
Sites / Locations
- Changhai Hospital, Second Military Medical University
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
3L PEG
3L PEG+Dyclonine Hydrochloride Mucilage
Arm Description
only used 3L PEG
used 3L PEG+Dyclonine Hydrochloride Mucilage
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
adenoma detection rate
The secondary end point of the study included adenoma detection rate
mean total adenomas detected beyond first
It was a new metric called ADR-Plus, the mean number of incremental adenomas after the fist.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03352700
Brief Title
Premedication Dyclonine Improves Visibility During Bowel Cleansing for Colonoscopy
Official Title
Premedication Dyclonine Improves Visibility During Bowel Cleansing for Colonoscopy
Study Type
Interventional
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Unknown status
Study Start Date
December 1, 2017 (Anticipated)
Primary Completion Date
January 1, 2018 (Anticipated)
Study Completion Date
February 1, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Changhai Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bowel Preparation Scale, the Amount of Air Bubble, Adenoma Detection Rate
7. Study Design
Primary Purpose
Screening
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
580 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
3L PEG
Arm Type
Placebo Comparator
Arm Description
only used 3L PEG
Arm Title
3L PEG+Dyclonine Hydrochloride Mucilage
Arm Type
Experimental
Arm Description
used 3L PEG+Dyclonine Hydrochloride Mucilage
Intervention Type
Drug
Intervention Name(s)
3L PEG
Intervention Description
Group A patients (n = 300) used only 3L PEG before colonoscopy.
Intervention Type
Drug
Intervention Name(s)
3L PEG+Dyclonine Hydrochloride Mucilage
Intervention Description
Patients in group B (n = 300) were additionally advised to Dyclonine Hydrochloride Mucilage plus 3 L PEG
Primary Outcome Measure Information:
Title
the amount of air bubbles
Description
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.
Time Frame
2 days
Secondary Outcome Measure Information:
Title
adenoma detection rate
Description
The secondary end point of the study included adenoma detection rate
Time Frame
2 days
Title
mean total adenomas detected beyond first
Description
It was a new metric called ADR-Plus, the mean number of incremental adenomas after the fist.
Time Frame
2 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhaosheng Li, MD
Phone
+86-21-31161335
Email
zhaoshenlismmu@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yu Bai
Phone
+86-13564665324
Email
baiyu1998@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peng Cheng
Organizational Affiliation
Changhai Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Changhai Hospital, Second Military Medical University
City
Shanghai
ZIP/Postal Code
200433
Country
China
12. IPD Sharing Statement
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Premedication Dyclonine Improves Visibility During Bowel Cleansing for Colonoscopy
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