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| Name | Class |
|---|---|
| LifeCell | INDUSTRY |
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The objective of this study is to examine the safety and efficacy of porcine acellular dermal matrix mesh (Strattice; LifeCell Corp., Branchburg, NJ) in crural reinforcement of laparoscopic large paraesophageal hernia repair.
Prosthetic reinforcements reduce recurrence rates; the choice of optimal prosthetic, either synthetic or biosynthetic, for crural reinforcement is controversial. The objective of this study is to examine the safety and efficacy of porcine acellular dermal matrix mesh (Strattice; LifeCell Corp., Branchburg, NJ) in crural reinforcement of laparoscopic large paraesophageal hernia repair. Strattice is a commonly used mesh in hernia repair. 35 adult (>19 years of age) patients will be selected based on inclusion and exclusion criteria. Patients who meet the criteria will be enrolled in the study. Information related to recurrence rates based on follow-up visits will be analyzed to determine the efficacy of Strattice in the prevention of large hernia recurrence.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Documented symptomatic paraesophageal hernia |
|
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| Measure | Description | Time Frame |
|---|---|---|
| Hernia recurrence | A barium swallow test with x-rays will be performed to assess recurrence of hernia, if any | 1 year post-surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence of reflux symptoms | Patients will be evaluated for recurrence of reflux symptoms at the three postoperative visits. If recurrence warrants, a barium swallow with x-rays will be performed prior to 1-year primary outcome barium swallow test | 2 weeks, 6 months and 1 year post-surgery |
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Inclusion Criteria:
Exclusion Criteria:
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Adults over 19 years of age with paraesophageal hernia greater than 5 cm.
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| Name | Affiliation | Role |
|---|---|---|
| Dmitry Oleynikov, MD | University of Nebraska | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Nebraska Medical Center | Omaha | Nebraska | 68198 | United States |
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| ID | Term |
|---|---|
| D006551 | Hernia, Hiatal |
| ID | Term |
|---|---|
| D006548 | Hernia, Diaphragmatic |
| D000082122 | Internal Hernia |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |