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Prospective registry comparing outcomes after laparoscopic treatment of gastroesophageal reflux disease and hiatal hernia.
This is a prospective, multi center, observational database of patients that are having surgical laparoscopic antireflux procedure and/or hiatal hernia repair, including laparoscopic Nissen fundoplication and Magnetic Sphincter Augmentation with the LINX device. Patients meeting registry inclusion and exclusion will be followed for 5 years with standardized quality of life surveys and appropriate standard of care testing. Up to 40 sites will participate with total enrollment of 1000 patients.
The main objectives are to collect data from everyday clinical practices and track patients from preoperative assessments to 5 years post surgical intervention to evaluate symptoms, medication use and side effects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Laparoscopic Fundoplication Group | This group of patients are surgical candidates based on preoperative testing results for laparoscopic fundoplication antireflux procedure and possible hiatal hernia repair. |
| |
| LINX Antireflux Device Group | This group of patients are surgical candidates based on preoperative testing results for the laparoscopic LINX antireflux device placement and possible hiatal hernia repair. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laparoscopic Fundoplication | Procedure | The gastric fundus of the stomach is wrapped or plicated around the lower end of the esophagus and and stitched in place reinforcing the closing function of the lower esophageal sphincter. The hiatus is also narrowed down with sutures or mesh to prevent or treat a concurrent hiatal hernia. |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life reported by patient | Standard GERD Quality of Life Assessment | 5 Years |
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Inclusion Criteria:
Exclusion Criteria:
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Male and female patient over the age of 21 with no maximum age who meet the eligibility for anti reflux and or hiatal hernia repair surgery
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| Name | Affiliation | Role |
|---|---|---|
| Reginald Bell, MD | The Heartburn Foundation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Advanced Surgeons, PC | Birmingham | Alabama | 35243 | United States | ||
| University of Southern Alabama |
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| LINX Antireflux | Device | The LINX is a flexible band of interlocked titanium beads with a magnetic core. The LINX is placed around the lower esophageal sphincter to help restore the function of the LES by preventing reflux into the esophagus. |
|
|
| Mobile |
| Alabama |
| 36617 |
| United States |
| The Arkansas Heartburn Treatment Center | Heber Springs | Arkansas | 72543 | United States |
| Bass Medical Group | Walnut Creek | California | 94598 | United States |
| HealthOne Cardiothoracic Surgery Associates | Aurora | Colorado | 80012 | United States |
| Institute of Esophageal and Reflux Surgery | Englewood | Colorado | 80113 | United States |
| Suncoast Surgical Associates | Brandon | Florida | 33511 | United States |
| South Florida Surgical Specialists, LLC | Coral Springs | Florida | 33065 | United States |
| Mayo Clinic | Jacksonville | Florida | 32224 | United States |
| Tampa Bay Reflux Center | Riverview | Florida | 33578 | United States |
| The Tampa Bay Reflux Center | Tampa | Florida | 33609 | United States |
| Coastal Carolina Bariatric and Surgical Center | Summerville | South Carolina | 29485 | United States |
| Baylor Scott and White Research Institute | Dallas | Texas | 75204 | United States |
| Baylor University Medical Center at Dallas | Dallas | Texas | 75246 | United States |
| Houston Methodist Research Institute | Houston | Texas | 77030 | United States |
| North Texas Surgical Oncology Associates | Plano | Texas | 75075 | United States |
| Swedish Health Services | Seattle | Washington | 98103 | United States |
| Affinity Medical Group | Chilton | Wisconsin | 53014 | United States |
| Froedtert & The Medical College of Wisconsin Hospitals and Health Partners | Milwaukee | Wisconsin | 53226 | United States |
| ID | Term |
|---|---|
| D005764 | Gastroesophageal Reflux |
| D006551 | Hernia, Hiatal |
| D006356 | Heartburn |
| D057045 | Laryngopharyngeal Reflux |
| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D006548 | Hernia, Diaphragmatic |
| D000082122 | Internal Hernia |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D007818 | Laryngeal Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D018662 | Fundoplication |
| ID | Term |
|---|---|
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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