Premedication Dyclonine Improves Visibility During Bowel Cleansing for Colonoscopy

Adenoma Detection Rate Clinical Trial

Official title:

Premedication Dyclonine Improves Visibility During Bowel Cleansing for Colonoscopy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03352700
• Other study ID #: Dyclonine-01
• Status: Not yet recruiting
• Phase: Phase 4
• First received: November 21, 2017
• Last updated: November 21, 2017
• Start date: December 1, 2017
• Est. completion date: February 1, 2018

Study information

• Verified date: November 2017
• Source: Changhai Hospital
• Contact: Zhaosheng Li, MD
• Phone: +86-21-31161335
• Email: zhaoshenlismmu[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 580
• Est. completion date: February 1, 2018
• Est. primary completion date: January 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Patients are between 18-75 years old

2. undergoing colonoscopy for diagnostic investigation, colorectal cancer screening or follow-up

Exclusion Criteria:

1. suspected gastrointestinal obstruction or perforation

2. severe acute inflammatory bowel disease

3. toxic megacolon

4. ileus or gastric retention, ileostomy,

5. hypersensitivity to any of the ingredients

6. pregnancy and lactation and/or at a risk of becoming pregnant

Related Conditions & MeSH terms

• Adenoma
• Adenoma Detection Rate
• Bowel Preparation Scale
• the Amount of Air Bubble

Intervention

Drug:
• 3L PEG
Group A patients (n = 300) used only 3L PEG before colonoscopy.
• 3L PEG+Dyclonine Hydrochloride Mucilage
Patients in group B (n = 300) were additionally advised to Dyclonine Hydrochloride Mucilage plus 3 L PEG

Locations

Country	Name	City	State
China	Changhai Hospital, Second Military Medical University	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Changhai Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	adenoma detection rate	The secondary end point of the study included adenoma detection rate	2 days
Secondary	mean total adenomas detected beyond first	It was a new metric called ADR-Plus, the mean number of incremental adenomas after the fist.	2 days