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the study failed in recruiting the required number of subjects (sample size) during its period
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Gastroesophageal reflux events generally happen during relaxation of lower esophageal sphincter. This relaxation is a reflex that is triggered by gastric stimuli. The investigators hypothesize that abnormal relaxation of the gastric wall after a meal may lead to reflux events. To test this hypothesis, a study was designed to measure the gastric accommodation in patients undergoing esophageal impedance monitoring.
Gastroesophageal reflux events happen during relaxations of lower esophageal sphincter not related to swallowing, called transient. These transient lower esophageal sphincter relaxations (tLESR) are generally triggered by gastric distension and its physiological purpose is to vent the stomach. The gastric accommodation is a physiological process in which the gastric fundus actively relaxes during a meal in order to accommodate it.
This study is driven by the hypothesis that impairment of the gastric accommodation may facilitate triggering tLESR and, therefore, reflux events. We aim to evaluate the relation between gastric fundic relaxation and the number of gastroesophageal reflux events in children. We also aim to evaluate if there is a relation between the gastric emptying and the number of reflux episodes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study group | Patients with symptoms suggesting gastroesophageal reflux and referred to perform an impedance study. |
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| Measure | Description | Time Frame |
|---|---|---|
| NUMBER OF REFLUX EPISODES | It is a cross-sectional exam, and the number of reflux episodes at baseline, after a clinically indicated 24-hour impedance study | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| Gastric volume ratio: 10 min/baseline | It is a cross-sectional study. This variable will be assessed by ultrasound in the next morning of the impedance study. | 1 day |
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Inclusion Criteria:
Exclusion Criteria:
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children and adolescents older than 1-year old who were referred for combined esophageal impedance pH monitoring for GERD symptoms, such as epigastric pain, respiratory symptoms, heartburn, feeding difficulties, chest pain, nausea or vomiting.
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| Name | Affiliation | Role |
|---|---|---|
| Rodrigo S Machado, MD, PhD | Nationwide Children's Hospital | Principal Investigator |
| Beth Skaggs, CCRC | Nationwide Children's Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nationwide Children's Hospital | Columbus | Ohio | 43205 | United States |
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| ID | Term |
|---|---|
| D005764 | Gastroesophageal Reflux |
| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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| D004066 | Digestive System Diseases |