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

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.

Study Overview

• Status: Completed
• Conditions: Disorder of Upper Esophageal Sphincter
• Intervention / Treatment: Diagnostic test: MII pH-meter

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.

• Study Type: Observational
• Enrollment (Actual): 98

Contacts and Locations

Study Locations

• Indonesia
  • DKI Jakarta
    • Jakarta, DKI Jakarta, Indonesia
      • RSCM

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patients with GERD

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
normoweight; GERD patient with normoweight was evaluating by MII pH-meter	Diagnostic test: MII pH-meter; using multichannel impedance pH-meter
obesity; GERD patient with obesity was evaluating by MII pH-meter	Diagnostic test: MII pH-meter; using multichannel impedance pH-meter

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite pH score/DeMesster Score	Participants underwent multichannel intraluminal impedance pH-meter (MII-pH) monitoring for quantification of the DeMeester score and acid exposure time	January 2017 - October 2017

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acid exposure time	Percent of acid exposure time (AET) at pH < 4 for each study groups	January 2017 - October 2017
Incidence of Hiatal Hernia	Incidence of hiatal hernia is measured for each group	January 2017 - October 2017
Incidence of Erosive Esophagitis	Incidence of erosive esophagitis is measured for each group	January 2017 - October 2017

Collaborators and Investigators

• Sponsor: Indonesia University

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2017
• Primary Completion (Actual): October 1, 2017
• Study Completion (Actual): July 1, 2018

Study Registration Dates

• First Submitted: August 12, 2020
• First Submitted That Met QC Criteria: August 5, 2022
• First Posted (Actual): August 9, 2022

Study Record Updates

• Last Update Posted (Actual): August 9, 2022
• Last Update Submitted That Met QC Criteria: August 5, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastroesophageal Reflux
• Other Study ID Numbers: IndonesiaSatu

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No