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2.2 Aim
2.4. 2- Study Setting: Department of Pathology, Faculty of Medicine, Assiut University.
c. Sample Size Calculation: Sample size was calculated using Epi- Info7. Based on The H. pylori-positive patients were more likely to develop dyslipidemia, and 77.47% of individuals testing positive for H. pylori have higher total cholesterol levels (11). With a confidence limit of 5% and a confidence level of 80%, the minimum number of patients required for this study is 114 cases
2.4.4 -Study tools The study will include 114 patients diagnosed with gastritis in the Gastroenterology unit and scheduled for upper gastrointestinal endoscopy with stomach biopsy. Written informed consent will be obtained from all patients participating in the study.
All subjects will be asked to complete a medical history questionnaire, followed by a physical examination (height, body weight, waist circumference, and blood pressure) and laboratory investigations (fasting blood glucose, liver function test, total cholesterol, triglycerides, low-density lipoprotein cholesterol, and high-density lipoprotein cholesterol( The endoscopy will be carried out by the same specialist, and it will assess chronic and acute gastritis, atrophic gastritis, and metaplasia. The endoscopist will obtain five biopsy samples: two from the antrum, two from the corpus, and one from the incisura.
All biopsies will be processed at the Pathology Department laboratory and embedded in paraffin blocks. For histological examination, two tissue sections will be stained: hematoxylin and eosin (H&E) and Giemsa stain. Each sample will undergo a double-blind review by two independent pathologists according to the USS (HP, neutrophils, mononuclear cells, atrophy, and intestinal metaplasia), and each variable will be graded semi-quantitatively.
Statistical analysis using suitable tests will be used to assess our results.
2.4.5 -Research outcome measures:
2.5-Data management and analysis : Data collection All subjects will be asked to complete a medical history questionnaire, followed by a physical examination (height, body weight, waist circumference, and blood pressure) and laboratory investigations (fasting blood glucose, liver function test, total cholesterol, triglycerides, low-density lipoprotein cholesterol, and high-density lipoprotein cholesterol.
Computer software Statistical package for social science (SPSS) program v. 25 (IBM, August 2017).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| cohort 1 gastritis patients | The study will include 114 patients diagnosed with gastritis in the Gastroenterology unit and scheduled for upper gastrointestinal endoscopy with stomach biopsy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| upper endoscopy | Diagnostic Test | All subjects will be asked to complete a medical history questionnaire, followed by physical examination (height, body weight, waist circumference and blood pressure), and laboratory investigations (fasting blood glucose, liver function test, total cholesterol, triglycerides, low-density lipoprotein cholesterol and high-density lipoprotein cholesterol( The endoscopy will be carried out by the same specialist, with assessment of chronic and acute gastritis, atrophic gastritis and metaplasia. The endoscopist will obtain five biopsies samples, two from the antrum, two from the corpus and one from incisura. All biopsies will be processed at the Pathology Department laboratory and embedded in paraffin blocks. For histological examination, two sets of tissue sections will be stained: one with hematoxylin and eosin (H&E) and the other with Giemsa stain. Each sample will undergo a double-blind review by two independent pathologists according to the USS (HP, neutrophils, mononuclear cells, atro |
| Measure | Description | Time Frame |
|---|---|---|
| Dyslipidemia | we will measure Low-density lipoprotein and serum cholesterol as a marker of dyslipidemia | periprocedural |
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Inclusion Criteria:
Exclusion Criteria:
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The study will include 114 patients diagnosed with gastritis in the Gastroenterology unit and scheduled for upper gastrointestinal endoscopy with stomach biopsy.
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| ID | Term |
|---|---|
| D005756 | Gastritis |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D013272 | Stomach Diseases |
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| ID | Term |
|---|---|
| D005773 | Gastroscopy |
| ID | Term |
|---|---|
| D016099 | Endoscopy, Gastrointestinal |
| D016145 | Endoscopy, Digestive System |
| D003938 | Diagnostic Techniques, Digestive System |
| D019937 | Diagnostic Techniques and Procedures |
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|
| D003933 | Diagnosis |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |