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

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

Status
Not yet recruiting
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06919120
Enrollment
3
Registered
2025-04-09
Start date
2025-06-01
Completion date
2027-10-31
Last updated
2025-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colonoscopy

Keywords

Dimethicone

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).

Interventions

DRUGSimethicone 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.

DRUGTake simethicone separately

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

Sponsors

The Fourth Affiliated Hospital of Zhejiang University School of Medicine
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Boston Bowel Preparation ScaleDuring the colonoscopy procedureBowel 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
Intestinal Bubble ScoreDuring the colonoscopy procedureBowel 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

MeasureTime frameDescription
Detection rate of polypsDuring the colonoscopy procedureThe detection rate of polyps ≤0.5 cm was compared between the two groups

Other

MeasureTime frameDescription
Time taken for colonoscope withdrawalDuring the colonoscopy procedureRecord 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.

Countries

China

Contacts

Primary ContactLinzhen Zhu, Bachelor
1504152@zju.edu.cn15958902187
Backup ContactHanfeng Lv, Bachelor
8620016@zju.edu.cn13868058637

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026