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OpenTrials
Completed

NCT Number: NCT02540239

Premedication Simethione Improves Visibility During Bowel Cleansing for Colonoscopy

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

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Key information

Conditions

Bowel Preparation Scale Adenoma Detection Rate the Amount of Air Bubble

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Changhai Hospital

Shanghai, Shanghai Municipality, 200433, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

2L PEG

Drug

2L PEG+simethicone

Drug

Primary outcomes

  1. adenoma detection rate

    Time frame: 2 days

  2. bowel preparation scale

    Time frame: 2 days

  3. the amount of air bubbles

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Changhai Hospital

Other

Collaborators

  • First Affiliated Hospital of Zhejiang University
  • First Hospital of China Medical University
  • Jinan Military General Hospital
  • Qilu Hospital of Shandong University
  • Sir Run Run Shaw Hospital
  • Tongji Hospital
  • Zhongda Hospital

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Sep 3, 2015
Registry last updated
Apr 19, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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