Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The investigators propose a randomized, single blinded controlled trial to compare the use of synthetic versus biologic mesh in hiatal hernia repair, two currently accepted standard of care surgical modalities. The investigators hypothesize that use of synthetic mesh will have lower recurrence at these time points compared to use of biologic mesh.
Patients will be randomized to either a synthetic (light weight synthetic or biologic (small intestinal submucosa ) mesh group. Endpoints will be measured up to 5 years for the study as a whole, at 6 months and at 60 months. Prior to and following laparoscopic paraesophageal hernia repair, patients will be followed with both subjective and objective measures. Subjective evaluation will include symptomatic/quality of life assessment at 1-, 6-, 24-, and 60- month periods; objective evaluation will include Upper GI study /pH probe study for symptomatic patients and for all patients at 6 and 60 months. The investigators hypothesize that use of synthetic mesh will have lower recurrence at these time points compared to use of biologic mesh.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Parietex™ Composite Hiatal Mesh, North Haven, CT | Active Comparator | Synthetic prosthetic mesh Parietex™ Composite Hiatal (PCO 2H) Mesh (Covidien, North Haven, CT) designed for hiatal hernia repair. |
|
| Biodesign™ Surgisis® Graft, Cook Medical, Bloomington | Active Comparator | Biologic mesh Biodesign™ Surgisis® Graft Reinforcement in Hiatal, Cook Medical, Bloomington, IN which will be placed for repair of hiatal hernia |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Parietex™ Composite Hiatal Mesh, North Haven, CT | Device | Parietex™ Composite Hiatal Mesh (North Haven, CT) designed for hiatal hernia repair. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Assess for reappearance of hiatal hernia and reflux | Change at 6 and 60 months will be assessed by pH and Upper GI (endoscopy) studies to assess for reappearance of hiatal hernia and reflux. | 6 months, 60 months |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life questionnaire | Quality of life questionnaire containing 36 questions | Quality of Life will be assessed at these time periods after the hernia repair 1, 6, 24, and 60 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stony Brook University Hospital | Recruiting | Stony Brook | New York | 11794 | United States |
Not provided
| ID | Term |
|---|---|
| D006551 | Hernia, Hiatal |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D006548 | Hernia, Diaphragmatic |
| D000082122 | Internal Hernia |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Biodesign™ Surgisis® Graft, Cook Medical, Bloomington | Device | Biodesign™ Surgisis® Graft (Cook Medical, Bloomington) designed for hiatal hernia repair. |
|
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |