跳至主要内容
临床试验/NCT00615303
NCT00615303已完成4 期

The Effectiveness of Simethicone In Improving Visibility During Colonoscopy: A Randomized, Placebo-controlled Study

Ramathibodi Hospital1 个研究点 分布在 1 个国家目标入组 194 人开始时间: 2006年12月最近更新:
适应症
干预措施
相关药物

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

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

Placebo Comparator

干预措施: Placebo (Drug)

1

Active Comparator

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Abhasnee Sobhonslidsuk

Associate professor

Ramathibodi Hospital

研究点 (1)

Loading locations...

相似试验

The Effectiveness of Simethicone In Improving... | 临床试验