Premedication Simethione Improves Visibility During Bowel Cleansing for Colonoscopy

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

COMPLETED

Clinical Phase

NA

Total Enrollment

590 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2016-04-30

Brief Summary

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To evaluate the efficacy, visibility of low volume polyethyleneglycol-simeticone (2-LPEG-S) for colonoscopy.

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Detailed Description

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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 2 L PEG before colonoscopy. Patients in group B (n = 300) were additionally advised to simeticone plus 2 L 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.

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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2L PEG

only used 2L PEG

Group Type PLACEBO_COMPARATOR

2L PEG

Intervention Type DRUG

Simethione+2L PEG

used 2L PEG+Simethione

Group Type EXPERIMENTAL

2L PEG+simethicone

Intervention Type DRUG

Interventions

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2L PEG

Intervention Type DRUG

2L PEG+simethicone

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients are between 18-65 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes