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Researchers are trying to identify predictors for gastroesophageal reflux disease after sleeve gastrectomy.
Subjects will undergo an upper endoscopy with EndoFLIP before sleeve gastrectomy to measure parameters from endoscopy and EndoFLIP device to develop a prediction model for post-operative gastroesophageal reflux disease. Subjects will undergo a repeat upper endoscopy with EndoFLIP at 6 months if an upper endoscopy is clinically indicated after surgery and complete questionnaires during follow-ups up to 5 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention arm | Experimental | Undergo an upper endoscopy with EndoFLIP at baseline before sleeve gastrectomy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EndoFLIP measurement | Device | EndoFLIP device can measure gastroesophageal junction distensibility index and esophageal contractile pattern under FDA cleared indication. It is performed during endoscopy. |
| Measure | Description | Time Frame |
|---|---|---|
| Worsening or new-onset gastroesophageal reflux disease | Determined by the change in the GERD-Health Related Quality of Life questionnaire score with questions individually scored on a scale of 0-5, combined to determine a total score range of 0-75 where a higher score indicates worse quality of life and increased score would indicate new or worsening GERD. | Baseline, 6 months, and 5 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Elizabeth Lemke | Contact | 5072663317 | Lemke.Elizabeth@mayo.edu |
| Name | Affiliation | Role |
|---|---|---|
| Omar Ghanem, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orlando Health | Active, not recruiting | Orlando | Florida | 32806 | United States | |
| Mayo Clinic in Rochester |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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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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| Recruiting |
| Rochester |
| Minnesota |
| 55905 |
| United States |
|
| D004066 | Digestive System Diseases |