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NCT Number: NCT06919120

The Study on the Effect of Different Administration Methods of Simethicone in Reducing Bubbles During Bowel Preparation

To find the simplest and most effective method of intestinal preparation for dimethicone administration.

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Key information

Conditions

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

the Fourth Affiliated Hospital of Zhejiang University

Yiwu, Zhejiang, China

About this study

A randomized controlled trial of dimethicone mixed with compound polyethylene glycol electrolyte powder (group A) versus dimethicone alone was conducted in patients undergoing colonoscopy (group B) the two different administration methods were used to compare the defoaming effect of dimethicone and the detection rate of polyps ≤0.5cm. To find the best way to administer dimethicone during bowel preparation for colonoscopy.

In group A (n = 686), a bottle of dimethicone was mixed with the last package of compound polyethylene glycol electrolyte powder, dissolved in 1000ml water, and finished within 1 hour during bowel preparation.

Group B (n = 686) received a bottle of dimethicone after taking the last sip of compound polyethylene glycol electrolyte powder.

Investigators asked each patient and physician about the interval between the administration of dimethicone and the initiation of colonoscopy, the time to colonoscopy withdrawal, the bowel cleanliness score, the intestinal bubble score, and whether polyps ≤0.5cm in diameter were detected.

SPSS25.0 was used to analyze the data with two independent samples t test. The gender, age, the interval between the end of antifoams and the start of the examination, the time of withdrawal from colonoscopy during the examination, the intestinal cleanliness score, the intestinal bubble score, and the detection of polyps with diameter ≤0.5cm were analyzed between group A (dimethicone mixed with compound polyethylene glycol electrolyte powder) and group B (dimethicone alone).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients undergoing routine colonoscopy at our hospital are aged between 18 to 80 years, including those who meet the Indications for colonoscopy without any absolute contraindications.

Exclusion criteria

  • (1) suffering from pancoliنى, intestinal obstruction, toxic megacolon, severe acute gastrointestinal infection, etc.; (2) individuals with severe dysfunction of the heart, lungs, liver, kidneys, etc.; (3) individuals with a history of allergic reaction to the above gastrointestinal agents; (4) individuals who cannot consent to treatment for epilepsy, etc.

Treatment and study plan

Simethicone is mixed into the final packet of compound polyethylene glycol electrolyte powder

Drug

The patients added one bottle of simethicone when taking the final packet of compound polyethylene glycol electrolyte powder.

Take simethicone separately

Drug

Take one bottle of simethicone orally after finishing the last sip of compound polyethylene glycol electrolyte solution.

Primary outcomes

  1. Boston Bowel Preparation Scale

    Time frame: During the colonoscopy procedure

    Bowel cleanliness was assessed using the Boston Bowel Preparation Scale (BBPS) in both groups, and the efficacy of bowel cleansing was compared between the two medication regimens to identify potential differences

  2. Intestinal Bubble Score

    Time frame: During the colonoscopy procedure

    Bowel foam levels were assessed using the Intestinal Bubble Score (IBS) in both groups, and the efficacy of foam clearance was compared between the two medication regimens to identify potential differences

Secondary outcomes

  1. Detection rate of polyps

    Time frame: During the colonoscopy procedure

    The detection rate of polyps ≤0.5 cm was compared between the two groups

Other outcomes

  1. Time taken for colonoscope withdrawal

    Time frame: During the colonoscopy procedure

    Record the endoscopy retraction time for two groups and compare whether there is a difference in the retraction time of endoscopy under the two different medication regimens.

Study contacts

Contact information is provided by the study sponsor or research team.

Hanfeng Lv, Bachelor

CONTACT

[email protected]

13868058637

Linzhen Zhu, Bachelor

CONTACT

[email protected]

15958902187

Sponsors and collaborators

Lead sponsor

The Fourth Affiliated Hospital of Zhejiang University School of Medicine

Other

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Apr 9, 2025
Registry last updated
Apr 9, 2025

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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