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

NCT ID: NCT06919120

Last Updated: 2025-04-09

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-01
• Study Completion Date: 2027-10-31

Brief Summary

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

Detailed 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).

Conditions

Colonoscopy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

A

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.

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

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

B

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

Group Type: EXPERIMENTAL

Take simethicone separately

Intervention Type: DRUG

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

Interventions

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

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

Intervention Type: DRUG

Take simethicone separately

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

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Fourth Affiliated Hospital of Zhejiang University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

the Fourth Affiliated Hospital of Zhejiang University

Yiwu, Zhejiang, China

Countries

China

Central Contacts

Linzhen Zhu, Bachelor

Role: CONTACT

1504152@zju.edu.cn

15958902187

Hanfeng Lv, Bachelor

Role: CONTACT

8620016@zju.edu.cn

13868058637

Other Identifiers

KY-2024-227

Identifier Type: -

Identifier Source: org_study_id