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Premedication Dyclonine Improves Visibility During Bowel Cleansing for Colonoscopy

NCT ID: NCT03352700

Last Updated: 2017-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

580 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-01

Study Completion Date

2018-02-01

Brief Summary

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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

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Conditions

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Bowel Preparation Scale the Amount of Air Bubble Adenoma Detection Rate

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

SINGLE

Investigators

Study Groups

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3L PEG

only used 3L PEG

Group Type PLACEBO_COMPARATOR

3L PEG

Intervention Type DRUG

Group A patients (n = 300) used only 3L PEG before colonoscopy.

3L PEG+Dyclonine Hydrochloride Mucilage

used 3L PEG+Dyclonine Hydrochloride Mucilage

Group Type EXPERIMENTAL

3L PEG+Dyclonine Hydrochloride Mucilage

Intervention Type DRUG

Patients in group B (n = 300) were additionally advised to Dyclonine Hydrochloride Mucilage plus 3 L PEG

Interventions

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3L PEG

Group A patients (n = 300) used only 3L PEG before colonoscopy.

Intervention Type DRUG

3L PEG+Dyclonine Hydrochloride Mucilage

Patients in group B (n = 300) were additionally advised to Dyclonine Hydrochloride Mucilage plus 3 L PEG

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Changhai Hospital

OTHER

Sponsor Role lead

Responsible Party

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Zhaoshen Li

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

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Peng Cheng

Role: PRINCIPAL_INVESTIGATOR

Changhai Hospital

Locations

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Changhai Hospital, Second Military Medical University

Shanghai, , China

Site Status

Countries

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China

Central Contacts

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Zhaosheng Li, MD

Role: CONTACT

Phone: +86-21-31161335

Email: [email protected]

Yu Bai

Role: CONTACT

Phone: +86-13564665324

Email: [email protected]

Other Identifiers

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Dyclonine-01

Identifier Type: -

Identifier Source: org_study_id