Premedication Simethione Improves Visibility During Bowel Cleansing for Colonoscopy

Not Applicable

Completed

• Conditions: the Amount of Air Bubble; Adenoma Detection Rate; Bowel Preparation Scale
• Interventions: Drug: 2L PEG; Drug: 2L PEG+simethicone

• Registration Number: NCT02540239
• Lead Sponsor: Changhai Hospital

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2015-01
• Study First Submitted: 2015-03-02
• Study First Submitted QC: 2015-09-01
• Study First Posted: 2015-09-03
• Primary Completion: 2016-02
• Status Verified: 2016-04
• Study Completion: 2016-04
• Last Update Submitted: 2016-04-18
• Last Update Posted: 2016-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 590

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2L PEG	2L PEG	only used 2L PEG
Simethione+2L PEG	2L PEG+simethicone	used 2L PEG+Simethione

Primary Outcome Measures

Name	Time	Method
adenoma detection rate	2 days
bowel preparation scale	2 days
the amount of air bubbles	2 days	Five areas of the colon (rectosigmoid, descending, transverse, ascending, and cecum) were graded for the amount of air bubbles.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.

Trial Locations

Locations (1)

Changhai Hospital; 🇨🇳 Shanghai, Shanghai, China