Clinical trial NCT06919120: The Study on the Effect of Different Administration Methods of Simethicone in Reducing Bubbles During Bowel Preparation
Official title: The Study on the Effect of Different Administration Methods of Simethicone in Reducing Bubbles During Bowel Preparation
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Colonoscopy
Keywords: Dimethicone
Lead sponsor: The Fourth Affiliated Hospital of Zhejiang University School of Medicine
Sponsor class: OTHER
First posted: 2025-04-09
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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).

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.

Primary outcomes:
measure: Boston Bowel Preparation Scale
timeFrame: During the colonoscopy procedure
measure: Intestinal Bubble Score
timeFrame: During the colonoscopy procedure
Secondary outcomes:
measure: Detection rate of polyps
timeFrame: During the colonoscopy procedure
Other outcomes:
measure: Time taken for colonoscope withdrawal
timeFrame: During the colonoscopy procedure
Locations:
city: Yiwu
country: China
facility: the Fourth Affiliated Hospital of Zhejiang University
state: Zhejiang
Study officials:
References: