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

• Sponsor: Indonesia University (Other)
• Overall Status: Completed
• CT.gov ID: NCT05493436
• Collaborator: (none)
• Enrollment: 98
• Location: 1
• Actual Duration (Months): 15
• Patients Per Site Per Month: 6.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Disorder of Upper Esophageal Sphincter	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 Design

• Study Type: Observational
• Actual Enrollment: 98 participants
• Observational Model: Case-Control
• Time Perspective: Cross-Sectional
• Official Title: The Influence of Obesity to Esophageal Reflux Severity Measured by pH-Metri Impedans on Gastroesophageal Reflux Disease Patients
• Actual Study Start Date: Apr 1, 2017
• Actual Primary Completion Date: Oct 1, 2017
• Actual Study Completion Date: Jul 1, 2018

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. Composite pH score/DeMesster Score [January 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

1. Acid exposure time [January 2017 - October 2017]

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

2. Incidence of Hiatal Hernia [January 2017 - October 2017]

   Incidence of hiatal hernia is measured for each group

3. Incidence of Erosive Esophagitis [January 2017 - October 2017]

   Incidence of erosive esophagitis is measured for each group

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	RSCM	Jakarta	DKI Jakarta	Indonesia

Sponsors and Collaborators

• Indonesia University

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol, Statistical Analysis Plan, and Informed Consent Form - Jan 1, 2018

More Information

Publications

None provided.

• Responsible Party: Ari Fahrial Syam, Clinical Professor, Staff of Gastroenterology Division, Department of Internal Medicine, Indonesia University
• ClinicalTrials.gov Identifier: NCT05493436
• Other Study ID Numbers: IndonesiaSatu
• First Posted: Aug 9, 2022
• Last Update Posted: Aug 9, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Gastroesophageal Reflux

Study Results

No Results Posted as of Aug 9, 2022