MedPath

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

Completed
Conditions
Disorder of Upper Esophageal Sphincter
Interventions
Diagnostic Test: MII pH-meter
Registration Number
NCT05493436
Lead Sponsor
Indonesia University
Brief Summary

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.

Detailed Description

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
98
Inclusion Criteria
  1. GERD patients diagnosed by GerdQ
  2. Adult patient age 18-60 years
  3. Patients with nutritional status based on normal BMI (18.5-24.9) and obesity (≥30)
  4. Willing to participate in research and sign informed consent
Exclusion Criteria
  1. At the endoscopic examination found Barrett's esophagus, peptic ulcer, severe gastritis, severe NSAID gastropathy, hemorrhage (melenae), gastric cancer, esophageal cancer
  2. MII-pH check failed to install
  3. Patients are not cooperative
  4. Patients with acute psychiatric disorders
  5. Patients with severe heart trouble, persistent asthma patients, decompensated liver cirrhosis and chronic renal disease

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
obesityMII pH-meterGERD patient with obesity was evaluating by MII pH-meter
normoweightMII pH-meterGERD patient with normoweight was evaluating by MII pH-meter
Primary Outcome Measures
NameTimeMethod
Composite pH score/DeMesster ScoreJanuary 2017 - October 2017

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

Secondary Outcome Measures
NameTimeMethod
Acid exposure timeJanuary 2017 - October 2017

Percent of acid exposure time (AET) at pH \< 4 for each study groups

Incidence of Erosive EsophagitisJanuary 2017 - October 2017

Incidence of erosive esophagitis is measured for each group

Incidence of Hiatal HerniaJanuary 2017 - October 2017

Incidence of hiatal hernia is measured for each group

Trial Locations

Locations (1)

RSCM

🇮🇩

Jakarta, DKI Jakarta, Indonesia

© Copyright 2025. All Rights Reserved by MedPath