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This is an open-label, multi-center, long-term, prospective hernia mesh registry. A minimum of 4,800 hernia patients will be enrolled from approximately 60 active sites globally
Patients will be followed for 2-years post-implantation, in a post-market setting to help identify best practices leading to lower recurrence rates and decreases in chronic pain, associated with the hernia repair procedure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observation Group | Subjects who meet the inclusion/exclusion criteria who have had a hernia repair. |
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| Measure | Description | Time Frame |
|---|---|---|
| Recurrence of the hernia | 1 month, 6-months, 12 months, 2 years | |
| Pain assessment scores by patients for the duration of the registry (Acute pain and Chronic pain) | 1 month, 6-months, 12 months, 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of post-operative complications/safety | At the time of surgery | |
| Assessment of procedure time | At the time of surgery |
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Inclusion Criteria
Patients must satisfy the following criteria before entering the registry:
Exclusion Criteria
Patients who meet any of the following criteria will be excluded from participating in the registry:
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Primary care clinic and patients of the investigators at local clinics or hospitals.
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| Name | Affiliation | Role |
|---|---|---|
| Niels-Derrek Schmitz, M.D. | Ethicon, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Florida Hospital Celebration Health | Celebration | Florida | 34747 | United States | ||
| Center for Hernia Repair |
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| Sarasota |
| Florida |
| 34139 |
| United States |
| Steward Norwood Hospital | Norwood | Massachusetts | 02062 | United States |
| University of Missouri-Columbia | Columbia | Missouri | 65212 | United States |
| SurgiCare of Missouri, P.C. | Jefferson City | Missouri | 65101 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| Queens Long Island Medical Group | Hicksville | New York | 11801 | United States |
| Laparoscopic Surgical Center of New York | New York | New York | 10028 | United States |
| Carolinas Medical Center | Charlotte | North Carolina | 28232 | United States |
| Owen Drive Surgical Clinic of Fayetteville | Fayetteville | North Carolina | 28304 | United States |
| Pinehurst Surgical Center | Pinehurst | North Carolina | 28374 | United States |
| South East Area Health Education Center (SEAHEC) | Wilmington | North Carolina | 28403 | United States |
| Southwest Specialty Clinics | Oklahoma City | Oklahoma | 73109 | United States |
| The Oregon Clinic | Portland | Oregon | 97225 | United States |
| North Penn Surgical Associates | Lansdale | Pennsylvania | 19446 | United States |
| Dallas Hernia Institute | Duncanville | Texas | 75116 | United States |
| Kirby Surgical Center | Houston | Texas | 77098 | United States |
| Eastern Virginia Medical School | Norfolk | Virginia | 23507 | United States |
| Queen Elizabeth Hospital | Woodville | South Australia | 5011 | Australia |
| MercyCare Mount Lawley Hospital | Mount Lawley | Western Australia | 6050 | Australia |
| The Wesley Hospital | Auchenflower | QLD 4066 | Australia |
| Imelda Hospital | Bonheiden | Belgium |
| University Hospital Ghent | Ghent | 9000 | Belgium |
| Centre for the Advancement of Minimally Invasive Surgery (CAMIS) | Edmonton | Alberta | T5H 1A8 | Canada |
| Hamilton Health Sciences - General | Hamilton | Ontario | L8L2X2 | Canada |
| St. Joseph's Hospital | Hamilton | Ontario | Canada |
| Huadong Hospital- Affilated to Fudan University | Shanghai | China |
| Hopital Prive D'Antony | Antony | France |
| CH Avignon - Service de Chirurgie Digestive | Avignon | 84902 | France |
| CHU Hotel Dieu | Clermont-Ferrand | France |
| Hospital Saint Philibert | Lomme | 59462 | France |
| Hopital Prive Mermoz | Lyon | 69008 | France |
| HIA Laveran | Marseille | 13384 | France |
| CHU de Nancy | Nancy | 54038 | France |
| Service de Chirurgie Generale et Cancerologie Digestiv | Nice | 06202 | France |
| Groupe Hospitalier Paris Saint-Joseph | Paris | 75014 | France |
| Centre Hospitalier Robert Debre | Reims | 51092 | France |
| Lukaskrankenhaus | Neuss | 41464 | Germany |
| Universita Cattolica Sacro Cuore | Rome | Italy |
| Jeroen Bosch Hospital | 's-Hertogenbosch | 5223 GZ | Netherlands |
| New Somerset Hospital | Cape Town | 8051 | South Africa |
| San Augustin De Aviles Hospital | Avilés | 33401 | Spain |
| University Hospital Virgen del Rocio | Seville | 41013 | Spain |
| Sodertalje Hospital | Södertälje | 152 86 | Sweden |
| Hinchingbrooke Hospital | Huntingdon | Cambrideshire | PE29GNT | United Kingdom |
| Royal United Hospital | Bath | Somerset | BA1 3NG | United Kingdom |
| University Hospitals of North Midlands | Stoke-on-Trent | Staffordshire | ST46QG | United Kingdom |
| Ayr Hospital | Ayr | KA6 6DX | United Kingdom |
| Dorset County Hospital | Dorchester | DT12JY | United Kingdom |
| Royal Bolton Hospital | Farnworth | BL4 0JR | United Kingdom |
| St Mary's Hospital | London | W2 1NY | United Kingdom |
| North Tyneside General Hospital | North Shields | United Kingdom |
| Northampton General Hospital | Northampton | United Kingdom |
| Royal Alexandra Hospital | Paisley | PA2 9PN | United Kingdom |
| ID | Term |
|---|---|
| D006547 | Hernia |
| ID | Term |
|---|---|
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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