Diagnostic Strategies in Patients Suspected of Irritable Bowel Syndrome and the Prevalence of Intestinal Parasites in Patients Suspected of Irritable Bowel Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 149
- 试验地点
- 1
- 主要终点
- health related quality of life measured by SF-36
研究概览
简要总结
The purpose of this study is to determine whether a clinical diagnosis of irritable bowel syndrome based on patient reported symptoms and a few blood tests is safe, and to determine whether a clinical diagnosis is as good for the patient and as economical for the society as a diagnosis based on exclusion of a number of organic diseases by performing a number of blood tests, fecal analyzes and a scopic examination of bowel.
The purpose of the second part of the study is to determine which intestinal parasites the patients have in their bowel and whether these parasites are the cause of the disease.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 18-50 years
- •consultant in general practice for gastrointestinal symptoms, where the GP suspects irritable bowel syndrome
- •full fill the ROME III criteria
- •signed informed consent
排除标准
- •alarm signals
- •pregnancy
- •comorbid diseases, that interfere with primary endpoint
- •medicine and alcohol abuse
- •patient do not speak or understand danish
- •investigations for irritable bowel syndrome with in the last 3 years
- •from november 2008: patients aged above 40 with a duration shorter than one year
结局指标
主要结局
health related quality of life measured by SF-36
时间窗: baseline and after 1 year
次要结局
- Symptoms measured by GSRS and GSRS-IBS(baseline, every month for a year and after 1 year)
- Health related quality of life measured by IBS-QOL measurement(baseline and after 1 year)
- sick days and reduced productivity measured by WPAI:IBS(baseline, every month and after 1 year)
- The overall satisfaction with the diagnostic strategy(after initial diagnostic work up and after 1 year)
- The use of resources in the health care system measured by the number of doctor visits, ambulatory visits, emergency room visits, hospitalizations and diagnostic tests over 1 year follow up.(every month and after 1 year)
- differential diagnoses in both arms(1 year)
研究者
Anne Line Oestergaard Engsbro
MD, phD-student
Zealand University Hospital