Clinical trial NCT05493436: The Influence of Obesity to Esophageal Reflux Severity Measured by pH-Metri Impedans on Gastroesophageal Reflux Disease Patients
Official title: The Influence of Obesity to Esophageal Reflux Severity Measured by pH-Metri Impedans on Gastroesophageal Reflux Disease Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Disorder of Upper Esophageal Sphincter
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2022-08-09
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with GERD

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.

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

Primary outcomes:
measure: Composite pH score/DeMesster Score
timeFrame: January 2017 - October 2017
Secondary outcomes:
measure: Acid exposure time
timeFrame: January 2017 - October 2017
measure: Incidence of Hiatal Hernia
timeFrame: January 2017 - October 2017
measure: Incidence of Erosive Esophagitis
timeFrame: January 2017 - October 2017
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: RSCM
state: DKI Jakarta
Study officials:
References: