Effectiveness of Rapid Urease Test (Helicotec) for The Diagnosis of Helicobacter Pylori Infection in Dyspepsia Patients in Endoscopy Centre
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 97
- 试验地点
- 1
- 主要终点
- Effectivity of Helicotec
研究概览
简要总结
Nowadays, the gold standard examinations for diagnosing H. pylori infection are histopathology and culture examination. However, those examinations take long preparation so they are not suitable to be applied in daily practice. In progress, another examination is being developed to detect urease enzyme from tissue biopsy. It is relatively faster in diagnosing H. Pylori infection. Some commercial urease tests which are available in Indonesia are Helicotec® and Pronto Dry®.
This study aims to determine the effectivity of Helicotec® in diagnosing H. pylori infection. It is expected to be scientific evidence that can be used as the basis daily routine of urease test in diagnosing H. Pylori infection.
详细描述
This study is a diagnostic study. There will be 97 dyspepsia patients who met the inclusion and exclusion criteria. They will answer the questionnaire about personal data and examined physically. They will also undergo endoscopy, biopsy, and urease test using Helicotec®
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult (18-55 years old),
- •Diagnosed with dyspepsia,
- •Indicated for endoscopy,
- •Agreed to participate in the study and signed the informed consent.
排除标准
- •Pregnancy and breastfeeding woman,
- •Patients with alarm symptom,
- •History taking of antibiotics (amoxicillin, clarithromycin, levofloxacin), H2 receptor antagonist, proton pump inhibitor, misoprostol, sucralfat, bismuth, NSAIDs, steroid, rheumatoid drug within the last 2 weeks.
结局指标
主要结局
Effectivity of Helicotec
时间窗: 1 day
Obtained the sensitivity and specificity value
次要结局
未报告次要终点
研究者
Ari Fahrial Syam
Staff of Gastroenterology Division, Internal Medicine Department
Indonesia University