Validation of New Type Radiopaque Marker in The Evaluation of Colonic Transit Time
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Correlation in the number of retained radiopaque markers from abdominal x-ray
研究概览
简要总结
The goal of this clinical trial is to learn if the local made colonic transit capsule can be use to diagnose slow transit constipation. The main questions it aims to answer are:
- Does the local made colonic transit capsule correlate with the standard colonic capsule in the diagnosis of slow transit constipation?
- Does the number of remained radiopaque marker similar between the two test after five days of ingestion?
Researchers will compare the local made colonic capsule with the standard Sitzmark colonic capsule to see the correlation.
Participants will:
- Take both local made colonic capsule and Sitzmark colonic capsule at the same time.
- Obtain abdominal x-ray 5 days after capsule ingestion.
- Keep a diary of their symptoms and medication used during investigation.
详细描述
The accurate diagnosis of constipation subtype is crucial especially in patients refractory to treatment. The current methods are expensive and not widely available. Thus, the investigators design the clinical study to evaluate the correlation and diagnostic accuracy of local made colonic transit capsule (Siriraj gastrointestinal transit capsule) compare with standard colonic capsule.
The patients with constipation and healthy volunteers will be enrolled. Participants will be asked to take both Sitzmark colonic capsule and Siriraj gastrointestinal transit capsule. The two capsules have different shape of radiopaque marker. The abdominal x-ray will be taken 5 days later. The number of radiopaque marker left will be counted separately between the two type of markers. Slow transit constipation is defined with retained more than 20% of radiopaque marker at 5 days after ingestion. Primary outcome is the correlation in the diagnosis of slow transit constipation and number of remained radiopaque markers between Sitzmark colonic capsule and Siriraj gastrointestinal transit capsule and the secondary outcome is the diagnostic performance of Siriraj gastrointestinal transit capsule in detecting slow transit constipation with Sitzmark colonic capsule as standard reference.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers with normal bowel habit not meet the criteria for functional constipation and irritable bowel syndrome with constipation according to Rome IV criteria
- •Participants with constipation according to Rome IV criteria
排除标准
- •Previous abdominal surgery
- •Participants at risk for intestinal obstruction such as endometriosis, history of intra-abdominal infection
- •Receive medication which affect colonic transit such as opioids
- •Pregnancy
研究组 & 干预措施
Experimental arm
10 participants with chronic constipation according to Rome IV criteria and 10 healthy volunteers will receive 1 Sitzmark colonic capsule (contains 24 radiopaque markers) and 4 Siriraj gastrointestinal transit capsule (each contains 6 radiopaque markers).
干预措施: Siriraj gastrointestinal transit capsule (Device)
Experimental arm
10 participants with chronic constipation according to Rome IV criteria and 10 healthy volunteers will receive 1 Sitzmark colonic capsule (contains 24 radiopaque markers) and 4 Siriraj gastrointestinal transit capsule (each contains 6 radiopaque markers).
干预措施: Sitz-Markers (Device)
结局指标
主要结局
Correlation in the number of retained radiopaque markers from abdominal x-ray
时间窗: 5 days after intervention
The correlation in the number of retained radiopaque markers in abdominal x-ray between Sitzmark colonic capsule and Siriraj gastrointestinal transit capsule.
Correlation in the diagnosis of slow transit constipation with radiopaque marker method
时间窗: 5 days after intervention
The correlation in the diagnosis of slow transit constipation between Sitzmark colonic capsule and Siriraj gastrointestinal transit capsule defined as retained 20% or more of radiopaque marker in abdominal x-ray after 5 days of ingestion.
次要结局
- Diagnostic performance of Siriraj gastrointesinal transit capsule(5 days after intervention)
研究者
Uayporn Kaosombatwattana
Assistant Professor
Mahidol University