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.

Study Overview

• Status: Not yet recruiting
• Conditions: Colonoscopy
• Intervention / Treatment: Drug: Simethicone is mixed into the final packet of compound polyethylene glycol electrolyte powder; Drug: Take simethicone separately

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).

• Study Type: Interventional
• Enrollment (Estimated): 3
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Linzhen Zhu, Bachelor; Phone Number: 15958902187; Email: 1504152@zju.edu.cn
• Study Contact Backup: Name: Hanfeng Lv, Bachelor; Phone Number: 13868058637; Email: 8620016@zju.edu.cn

Study Locations

• China
  • Zhejiang
    • Yiwu, Zhejiang, China
      • the Fourth Affiliated Hospital of Zhejiang University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: 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.
Experimental: B; The patients in this group took one bottle of simethicone orally after finishing the last sip of compound polyethylene glycol electrolyte solution.	Drug: Take simethicone separately; Take one bottle of simethicone orally after finishing the last sip of compound polyethylene glycol electrolyte solution.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Boston Bowel Preparation Scale	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	During the colonoscopy procedure
Intestinal Bubble Score	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	During the colonoscopy procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Detection rate of polyps	The detection rate of polyps ≤0.5 cm was compared between the two groups	During the colonoscopy procedure

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time taken for colonoscope withdrawal	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.	During the colonoscopy procedure

Collaborators and Investigators

• Sponsor: The Fourth Affiliated Hospital of Zhejiang University School of Medicine

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): October 31, 2027

Study Registration Dates

• First Submitted: April 2, 2025
• First Submitted That Met QC Criteria: April 2, 2025
• First Posted (Actual): April 9, 2025

Study Record Updates

• Last Update Posted (Actual): April 9, 2025
• Last Update Submitted That Met QC Criteria: April 2, 2025
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Dimethicone
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Dermatologic Agents; Emollients; Antifoaming Agents; Simethicone
• Other Study ID Numbers: KY-2024-227

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No