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

NCT ID: NCT05493436

Last Updated: 2022-08-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 98 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-04-01
• Study Completion Date: 2018-07-01

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.

Conditions

Disorder of Upper Esophageal Sphincter

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

normoweight

GERD patient with normoweight was evaluating by MII pH-meter

MII pH-meter

Intervention Type: DIAGNOSTIC_TEST

using multichannel impedance pH-meter

obesity

GERD patient with obesity was evaluating by MII pH-meter

MII pH-meter

Intervention Type: DIAGNOSTIC_TEST

using multichannel impedance pH-meter

Interventions

MII pH-meter

using multichannel impedance pH-meter

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Indonesia University

OTHER

Sponsor Role: lead

Responsible Party

Ari Fahrial Syam

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

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

RSCM

Jakarta, DKI Jakarta, Indonesia

Countries

Indonesia

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

IndonesiaSatu

Identifier Type: -

Identifier Source: org_study_id