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The trial would to try to establish:
45 patients candidate to primary SG and randomized in 3 study groups (15 per group) GROUP A: no treatment (control group)
GROUP B (standard dose-long term): Lansoprazole buccal tablets 30 mg once daily (before breakfast on an empty stomach) for 6 months
GROUP C (standard dose-short term): Lansoprazole buccal tablets 30 mg once daily (before breakfast on an empty stomach) for 3 months
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GROUP A - no PPI | No Intervention | no PPI treatment (control group) | |
| GROUP B PPI 1/day for 6 months | Experimental | (standard dose-long term): Lansoprazole oral tablets 30 mg once daily (before breakfast on an empty stomach) for 6 months |
|
| GROUP C PPI 1/day for 3 months | Experimental | (standard dose-short term): Lansoprazole oral tablets 30 mg once daily (before breakfast on an empty stomach) for 3 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lansoprazole oral tablets 30 mg | Drug | Post operative prescription |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of post-operative GERD based on the trial protocol. Clinical evaluation | Questionnaire evaluation (GERD-HRQL score from 0 (no symptoms) to 5 (symptoms worsening daily activity) and GERD-Q (score A <8 no GERD, score A >8 and B > 3 GERD worsening normal life) | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| evaluate in each group of the study (arm type) the endoscopic finding of peptic lesions of the esophagus-gastro-duodenal mucosa at 24 months of follow-up | Mucosal damage evaluation and stratified accordingly | 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Rome "la sapienza" | Latina | 04100 | Italy |
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| ID | Term |
|---|---|
| D005764 | Gastroesophageal Reflux |
| D001471 | Barrett Esophagus |
| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| D064747 | Lansoprazole |
| ID | Term |
|---|---|
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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| D004066 | Digestive System Diseases |
| D011230 | Precancerous Conditions |
| D009369 | Neoplasms |
| D011725 |
| Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |