跳至主要内容
临床试验/NCT06585176
NCT06585176
已完成
不适用

Epidemiological Studies and Risk Factor Analysis of Gastroesophageal Reflux Diseases in Xiamen City: a Cross-sectional Study

Zhongshan Hospital (Xiamen), Fudan University1 个研究点 分布在 1 个国家目标入组 1,625 人2024年8月1日

概览

阶段
不适用
干预措施
No intervention
疾病 / 适应症
Gastroesophageal Reflux Disease
发起方
Zhongshan Hospital (Xiamen), Fudan University
入组人数
1625
试验地点
1
主要终点
The prevalence of GERD in Xiamen city
状态
已完成
最后更新
上个月

概览

简要总结

Gastroesophageal Reflux Disease (GERD) is a condition characterized by the reflux of gastric and duodenal contents into the esophagus, primarily manifested by symptoms such as acid regurgitation and heartburn. GERD significantly affects patients' daily lives and health-related quality of life. Prolonged gastroesophageal reflux can lead to repeated irritation of the esophageal mucosa by gastric acid and acidic gastric contents, resulting in the replacement of normal squamous epithelium in the lower esophagus with metaplastic columnar epithelium. This pathological change, known as Barrett's Esophagus (BE), is considered a precancerous lesion for esophageal adenocarcinoma.

详细描述

GERD is a common gastrointestinal disorder with numerous risk factors that negatively impact patients' quality of life. Abnormal psychological conditions may influence various aspects of GERD, including its onset, diagnosis, treatment, and prognosis. The incidence and risk factors of GERD vary in different countries or regions. Currently, there is a lack of unified national epidemiological data on GERD in China. Conducting epidemiological studies on GERD in China to identify risk factors and develop prevention and treatment measures tailored to the country's or specific regions' circumstances is crucial for reducing the incidence of GERD and improving patients' quality of life. In the context of the modern biomedical model of "biopsychosocial" health, actively researching the psychological conditions of patients, while also addressing their physical ailments and providing psychological treatment, emphasizes holistic care. This approach may comprehensively alleviate disease symptoms and enhance quality of life, potentially leading to new breakthroughs in the treatment of GERD. Based on this, a specialized cohort for gastroesophageal reflux disease will be established, along with multicenter epidemiological and clinical research in the Xiamen area. This initiative will help clarify the etiology of GERD and provide firsthand resources for evidence-based prevention and treatment.

注册库
clinicaltrials.gov
开始日期
2024年8月1日
结束日期
2025年10月31日
最后更新
上个月
研究类型
Observational
性别
All

研究者

发起方
Zhongshan Hospital (Xiamen), Fudan University
责任方
Principal Investigator
主要研究者

Yucheng Zhu

Deputy Chief Physician

Zhongshan Hospital (Xiamen), Fudan University

入排标准

入选标准

  • All patients had experienced typical reflux symptoms, i.e., mild heartburn and/or regurgitation symptoms, for at least 2 days per week or moderate/severe reflux symptoms for more than 1 day per week during the previous 3 months and had upper endoscopy examinations in the previous month.
  • Cooperate with the questionnaire survey.
  • Volunteer and sign the informed consent form.
  • Permanent residents in Xiamen.

排除标准

  • Malignant tumor.
  • Partial or total gastrectomy.
  • Failing to cooperate with the investigation because of the factors such as education level and language intelligence disorder, etc.
  • Patients with severe heart, lung, kidney, liver, blood, nerve, endocrine and mental system diseases.
  • Patients with mental retardation, etc.

研究组 & 干预措施

Gastroesophageal Reflux Disease

Gastroesophageal reflux disease (GERD) is a gastrointestinal motility disorder that results from the reflux of stomach contents into the esophagus or oral cavity resulting in symptoms or complications.

干预措施: No intervention

结局指标

主要结局

The prevalence of GERD in Xiamen city

时间窗: 3 months.

Gastroesophageal reflux disease (GERD) is the most prevalent gastrointestinal disorder in the world. In this study, we will study the incidence of GERD in Xiamen city.

The percentage of reflux esophagitis

时间窗: 3 months.

The percentage of participants diagnosed with reflux esophagitis using endoscopy among patients with baseline symptoms.

The percentage of Barrett esophagus

时间窗: 3 months.

The percentage of paticipants diagnosed with pathological Barrett esophagus using endoscopy monitoring among patients with baseline symptom in gastroenterology department will be calculated.

次要结局

  • The life quality of GERD patients who were diagnosed by endoscopy(3 months.)
  • The sensitivity of GERD-Q for diagnosis of GERD(3 months.)
  • The specificity of GERD-Q for diagnosis of GERD(3 months.)

研究点 (1)

Loading locations...

相似试验