The Effectiveness of Simethicone In Improving Visibility During Colonoscopy: A Randomized, Placebo-controlled Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 194
- 试验地点
- 1
- 主要终点
- Visibility: air bubble and haziness
研究概览
简要总结
Sodium phosphate is one of the bowel preparation regimens for colonoscopy. However, intraluminal gas can impair visibility during the examination. Simethicone is medication that works by reducing the surface tension of air bubbles. We aimed to evaluate the effect of simethicone in enhancing visibility and efficacy during colonoscopy.
详细描述
A prospective, randomized, double-blinded, placebo-controlled study was conducted. One hundred and twenty-four patients were allocated to receive 2 dosages of either 45 ml of sodium phosphate plus 240 mg of simethicone tablets or 45 ml of sodium phosphate plus placebo in the evening before and in the morning of the procedure day. The colonoscopic examination was recorded. Visibility was blindly assessed for the amount of air bubbles and the degree of haziness by a single investigator. Five areas of the colon were graded for the amount of air bubbles, from 0 to 3; grade 0 and 1 were defined as the diminishing of air bubbles. The haziness was graded into 5 levels from excellent to unacceptable. Excellent, good and adequate were defined as the diminishing of haziness. The total duration of colonoscopy, the side effect of medication and the endoscopist and patient satisfaction were compared between 2 groups. Endoscopist satisfaction was evaluated by questionnaires. Visual analog scale (0-10) was used for rating patient satisfaction and the side effect of medication.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with age 18-70 yrs old who undergo colonoscopy at the endoscopic unit of the hospital
排除标准
- •Renal insufficiency (Cr >2.3 mg/dl)
- •Congestive heart failure
- •Massive ascites
- •Acute myocardial infarction within 6 months
- •Coagulopathy
- •Previous colonic surgery
- •Suspected of colonic obstruction Pregnancy Refuse to give inform consent
研究组 & 干预措施
2
干预措施: Placebo (Drug)
1
干预措施: Simethicone (Drug)
结局指标
主要结局
Visibility: air bubble and haziness
时间窗: During colonoscopy
次要结局
- Total colonoscopic time, patient and doctor satisfaction and side effects(During colonscopy)
研究者
Abhasnee Sobhonslidsuk
Associate professor
Ramathibodi Hospital
