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

The Fourth Affiliated Hospital of Zhejiang University School of Medicine

Status and phase: Not yet enrolling; Phase 4

Conditions: Colonoscopy

Treatments: Drug: Simethicone is mixed into the final packet of compound polyethylene glycol electrolyte powder; Drug: Take simethicone separately

Study type: Interventional

Funder types: Other

Identifiers

NCT06919120

KY-2024-227

Details and patient eligibility

About

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

Full description

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).

Enrollment: 3 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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3 participants in 2 patient groups

A

Experimental group

Description:

The patients in this group mixed one bottle of simethicone into the final packet of compound polyethylene glycol electrolyte powder, dissolved it in 1000 ml of water, and consumed it within one hour.

Treatment:

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

B

Experimental group

Description:

The patients in this group took one bottle of simethicone orally after finishing the last sip of compound polyethylene glycol electrolyte solution.

Treatment:

Drug: Take simethicone separately