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临床试验/NCT05493436
NCT05493436已完成不适用

The Influence of Obesity to Esophageal Reflux Severity Measured by pH-Metri Impedans on Gastroesophageal Reflux Disease Patients

Indonesia University1 个研究点 分布在 1 个国家目标入组 98 人开始时间: 2017年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
98
试验地点
1
主要终点
Composite pH score/DeMesster Score

研究概览

简要总结

To see a more convincing relationship between increased body mass index and the severity of esophageal reflux in GERD patients, GERD diagnosis should be performed with greater precision or precision. From the available data, it appears that no studies in Indonesia have correlated the body mass index with the severity of esophageal reflux events measured by multical intraluminal intraluminal pH-metric in patients with GERD due to the invasive nature of the test. Therefore, research needs to be done to assess the effect of increased body mass index on the severity of esophageal reflux as measured by multical intraluminal impedance pH-metric in GERD patients.

详细描述

Gastroesophageal reflux disease (GERD) prevalence is increasing worldwide. It is known that GERD correlates with obesity. In order to see further association between obesity and severity degree of esophageal reflux, GERD must be diagnosed with greater precision and accuracy. Therefore, study to see the impact of obesity in esophageal reflux severity measured by multicanal intraluminal impedance pH-meter (MII-pH) in GERD patient is compulsory.

The objective of this study is to explain the impact of obesity on severity of esophageal reflux in GERD patient measured by DeMeester score, hiatal hernia incidence, and the prolongation of acid exposure time in GERD patient.

This cross-sectional study recruited patients from Gastroenterology Clinic, Internal Medicine Department Cipto Mangunkusumo Hospital during May-August 2017. Patient with normal and obese body mass index (BMI) suspected having GERD were surveyed using GERDQ to diagnose GERD in these patients. Upper gastrointestinal endoscopy were performed to see hiatal hernia. All patients recruited underwent MII-pH examination to measure DeMeester score and acid exposure time. Results were analyzed using bivariat analysis.

研究设计

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

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • GERD patients diagnosed by GerdQ
  • Adult patient age 18-60 years
  • Patients with nutritional status based on normal BMI (18.5-24.9) and obesity (≥30)
  • Willing to participate in research and sign informed consent

排除标准

  • At the endoscopic examination found Barrett's esophagus, peptic ulcer, severe gastritis, severe NSAID gastropathy, hemorrhage (melenae), gastric cancer, esophageal cancer
  • MII-pH check failed to install
  • Patients are not cooperative
  • Patients with acute psychiatric disorders
  • Patients with severe heart trouble, persistent asthma patients, decompensated liver cirrhosis and chronic renal disease

结局指标

主要结局

Composite pH score/DeMesster Score

时间窗: January 2017 - October 2017

Participants underwent multichannel intraluminal impedance pH-meter (MII-pH) monitoring for quantification of the DeMeester score and acid exposure time

次要结局

  • Acid exposure time(January 2017 - October 2017)
  • Incidence of Erosive Esophagitis(January 2017 - October 2017)
  • Incidence of Hiatal Hernia(January 2017 - October 2017)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ari Fahrial Syam

Clinical Professor, Staff of Gastroenterology Division, Department of Internal Medicine

Indonesia University

研究点 (1)

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