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

NCT06919120 | Not Yet Recruiting Phase 4

• 1 other identifier: KY-2024-227
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Colonoscopy

Keywords

Dimethicone

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Detection rate of polyps

  During the colonoscopy procedure

Other Outcomes (1)

• Time taken for colonoscope withdrawal

  During the colonoscopy procedure

Study Arms (2)

A

EXPERIMENTAL

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

B

EXPERIMENTAL

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

Interventions

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.

A

Take simethicone separately DRUG

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

B

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• （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.

Sponsors & Collaborators

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

Study Sites (1)

the Fourth Affiliated Hospital of Zhejiang University

Yiwu, Zhejiang, China

Location

Central Study Contacts

Linzhen Zhu, Bachelor

CONTACT

15958902187; 1504152@zju.edu.cn

Hanfeng Lv, Bachelor

CONTACT

13868058637; 8620016@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2025
• First Posted: April 9, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): October 31, 2027
• Last Updated: April 9, 2025

Record last verified: 2024-12

Locations

CN (1)