Premedication Dyclonine Improves Visibility During Bowel Cleansing for Colonoscopy

Naval Military Medical University

Status and phase: Unknown; Phase 4

Conditions: Bowel Preparation Scale; the Amount of Air Bubble; Adenoma Detection Rate

Treatments: Drug: 3L PEG; Drug: 3L PEG+Dyclonine Hydrochloride Mucilage

Study type: Interventional

Funder types: Other

Identifiers

NCT03352700

Dyclonine-01

Details and patient eligibility

About

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.

Enrollment: 580 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

580 participants in 2 patient groups, including a placebo group

3L PEG

Placebo Comparator group

Description:

only used 3L PEG

Treatment:

Drug: 3L PEG

3L PEG+Dyclonine Hydrochloride Mucilage

Experimental group

Description:

used 3L PEG+Dyclonine Hydrochloride Mucilage

Treatment:

Drug: 3L PEG+Dyclonine Hydrochloride Mucilage