Premedication Simethione Improves Visibility During Bowel Cleansing for Colonoscopy

Naval Military Medical University

Status: Completed

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

Treatments: Drug: 2L PEG+simethicone; Drug: 2L PEG

Study type: Interventional

Funder types: Other

Identifiers

NCT02540239

simethione

Details and patient eligibility

About

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

Full description

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.

Enrollment: 590 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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590 participants in 2 patient groups, including a placebo group

2L PEG

Placebo Comparator group

Description:

only used 2L PEG

Treatment:

Drug: 2L PEG

Simethione+2L PEG

Experimental group

Description:

used 2L PEG+Simethione

Treatment:

Drug: 2L PEG+simethicone