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This feasibility study highlights the features of the 3D dynamic responsive prosthesis ProFlor-E® for fixation free obliteration of inguinal hernia defect
The 3D dynamic-responsive prosthesis for inguinal hernia repair ProFlor-E® recently introduced to the market has been laparoscopically employed for the repair of one recurrent inguinal hernia previously managed with anterior open approach. The scope of this feasibility study is to demonstrate that the positive effects of the 3D implant already proven in open inguinal hernia repair are also effective or even superior for the laparoscopic of recurrent/bilateral inguinal hernias compared to conventional treatment concept.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Inguinal hernia repair laparoscopic | Experimental | recurrent inguinal hernia after open repair or bilateral hernia patients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ProFlor laparoscopic technique | Device | Inguinal hernia repair laparoscopic |
|
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of inguinal hernia defect obliteration with ProFlor | Effectiveness of the laparoscopic procedure for inguinal hernia repair with ProFlor | intraoperative |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative pain | assessment of postoperative pain through Visual Analogue Scale | from early stage until 18 months postop |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Giuseppe Amato, MD | University of Cagliari - University of Palermo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Palermo | Palermo | Please Select | 90100 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21752035 | Background | Amato G, Lo Monte AI, Cassata G, Damiano G, Romano G, Bussani R. A new prosthetic implant for inguinal hernia repair: its features in a porcine experimental model. Artif Organs. 2011 Aug;35(8):E181-90. doi: 10.1111/j.1525-1594.2011.01272.x. Epub 2011 Jul 13. | |
| 25626584 | Background | Amato G, Romano G, Agrusa A, Marasa S, Cocorullo G, Gulotta G, Goetze T, Puleio R. Biologic response of inguinal hernia prosthetics: a comparative study of conventional static meshes versus 3D dynamic implants. Artif Organs. 2015 Jan;39(1):E10-23. doi: 10.1111/aor.12416. |
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| ID | Term |
|---|---|
| D006552 | Hernia, Inguinal |
| ID | Term |
|---|---|
| D046449 | Hernia, Abdominal |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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feasibility study
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| Background | Amato G, Romano G, Goetze T, Cicero L, Gulotta E, Calò PG, Agrusa A Fixation free inguinal hernia repair with the 3D dynamic responsive prosthesis ProFlor: Features, procedural steps and long-term results. International Journal of Surgery Open 2019; 21:34-4 |