Premedication Dyclonine Improves Visibility During Bowel Cleansing for Colonoscopy

Phase 4

• Conditions: Adenoma Detection Rate; Bowel Preparation Scale; the Amount of Air Bubble
• Interventions: Drug: 3L PEG+Dyclonine Hydrochloride Mucilage; Drug: 3L PEG

• Registration Number: NCT03352700
• Lead Sponsor: Changhai Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2017-11
• Study First Submitted: 2017-11-21
• Study First Submitted QC: 2017-11-21
• Last Update Submitted: 2017-11-21
• Study First Posted: 2017-11-24
• Last Update Posted: 2017-11-24
• Study Start: 2017-12-01
• Primary Completion: 2018-01-01
• Study Completion: 2018-02-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 580

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3L PEG+Dyclonine Hydrochloride Mucilage	3L PEG+Dyclonine Hydrochloride Mucilage	used 3L PEG+Dyclonine Hydrochloride Mucilage
3L PEG	3L PEG	only used 3L PEG

Primary Outcome Measures

Name	Time	Method
the amount of air bubbles	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 Outcome Measures

Name	Time	Method
adenoma detection rate	2 days	The secondary end point of the study included adenoma detection rate
mean total adenomas detected beyond first	2 days	It was a new metric called ADR-Plus, the mean number of incremental adenomas after the fist.

Trial Locations

Locations (1)

Changhai Hospital, Second Military Medical University; 🇨🇳 Shanghai, China