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

Обзор

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

Подробное описание

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).

Вмешательства

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

Первичные конечные точки

• Boston Bowel Preparation Scale [Срок оценки: During the colonoscopy procedure]
• Intestinal Bubble Score [Срок оценки: During the colonoscopy procedure]

Вторичные конечные точки (1)

• Detection rate of polyps [Срок оценки: During the colonoscopy procedure]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• （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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Другое

Центры проведения

Китай · 1 центр

• the Fourth Affiliated Hospital of Zhejiang University — Yiwu

Идентификаторы

NCT: NCT06919120 · KY-2024-227

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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