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临床试验/NCT03479528
NCT03479528Unknown不适用

The Predictive Value of Alarm Symptoms in Patients With Dyspepsia Based on Roman IV

Second Affiliated Hospital of Xi'an Jiaotong University1 个研究点 分布在 1 个国家目标入组 800 人开始时间: 2018年3月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
800
试验地点
1
主要终点
The incidence of organic dyspepsia.

研究概览

简要总结

Functional dyspepsia is one of the most common gastrointestinal disorders (FGIDs) encountered in clinical practice.Clinical diagnosis is notoriously unreliable in diagnosing the underlying cause of dyspepsia,but a number of alarm features have been suggested as indicating patients at higher risk for serious disease. The predictive value of alarm symptoms still require more researches. Rome IV introduced more precisely define the minimal thresholds for frequency and severity of each individual symptom, primarily for scientific purposes,but data still need to be collected to define thresholds based on the frequency and/or severity of symptoms that impair quality of life.A cross-sectional study was conducted to assess the predictive value of alarm symptoms in patients with dyspepsia based on Roman IV.Through endoscopy results to determine whether dyspepsia is organic or functional, benign or malignant, through contacts with the basic data, to determine the alarm symptoms

详细描述

Functional dyspepsia is one of the most common gastrointestinal disorders (FGIDs) encountered in clinical practice. Functional dyspepsia is a clinical syndrome characterized by chronic and recurrent gastroduodenal symptoms in the absence of any organic or metabolic disease that is likely to explain the symptoms.Functional dyspepsia has a high incidence in the population.Clinical diagnosis is notoriously unreliable in diagnosing the underlying cause of dyspepsia,but a number of alarm features have been suggested as indicating patients at higher risk for serious disease.However, previous studies noted that the sensitivity of alarm features for predicting cases with upper GI malignancies is unsatisfactory. The predictive value of alarm symptoms still require more researches. Rome IV was introduced in 2016. Rome IV introduced more precisely define the minimal thresholds for frequency and severity of each individual symptom, primarily for scientific purposes,but data still need to be collected to define thresholds based on the frequency and/or severity of symptoms that impair quality of life.A cross-sectional study was conducted to assess the predictive value of alarm symptoms in patients with dyspepsia based on Roman IV.All patients who were satisfied with the inclusion criteria and exclusion criteria in the department of the second affiliated hospital of Xi'an jiaotong university, Xijing Hospital, Tangdu Hospital, Xi'an No.3 Hospital, and received investigation.Inclusion criteria included:Symptoms of upper digestive tract for more than 6 months or 3 monthes(postprandial fullness, early satiation,epigastric pain, and epigastric burning);Older than 18;From March 2018 to January 2011,received gastroscope and upper abdominal B ultrasound examination;agreeing the informed consent.Data collection:Basic information:name, age, height, weight, gender, marriage;Dyspepsia: symptoms of indigestion, duration of indigestion, and weekly incidence of indigestion;Abnormal symptoms: weight loss, anemia, anorexia, vomiting, blackstool, dysphagia;Lifestyle habits: spicy food, smoking, drinking, sleep quality, daily exercise time;Family history, helicobacter pylori infection, abdominal color ultrasound results,Cost.Through endoscopy results to determine whether dyspepsia is organic or functional, benign or malignant, through contacts with the basic data, to determine the alarm symptoms.Further more, this study was proved by the ethical committee of second hospital of Xi'an jiaotong university.

研究设计

研究类型
Observational
观察模型
Case Crossover
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

The incidence of organic dyspepsia.

时间窗: 3 months

To collect the results of gastroscopy in patients who meet inclusion criteria, and to calculate the incidence of organic dyspepsia to analyze the predictive value of alarm symptoms.

次要结局

  • The incidence of gastric cancer(3 months)

研究者

发起方
Second Affiliated Hospital of Xi'an Jiaotong University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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