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The investigation is aimed at specifically demonstrating the ingrowth of newly formed nervous elements within a 3D dynamic responsive implant for inguinal hernia repair.
Biopsy specimen were excised at defined postoperative stages from patients who underwent hernia repair with the 3D prosthesis named ProFlor. Scope of the study was to determine the presence, quantity and quality of the neural ingrowth within the implant fabric. Histology revealed the presence of multiple nerve clusters that, starting from the early stage post-implantation, increased in number and degree of maturation. In the long term, neural elements assumed the typical aspect of normal nervous structures complete in all components. The development of highly specialized tissue such as nerves, together with other components of the abdominal wall already described in literature, seems to finalize a regenerative response. This kind of behavior, being the expected result from a device intended for the cure of inguinal hernia and its degenerative source, seems to be coherent with the pathogenesis of the disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Short term post inguinal hernia repair wit ProFlor | Active Comparator | Determining presence and level of maturation of nervous structures in the hernia implant named ProFlor at 3-5 weeks post implantation |
|
| Mid term post inguinal hernia repair wit ProFlor | Active Comparator | Determining presence and level of maturation of nervous structures in the hernia implant named ProFlor at 3-4 months post implantation |
|
| Long term post inguinal hernia repair wit ProFlor | Active Comparator | Determining presence and level of maturation of nervous structures in the hernia implant named ProFlor at 6-8 months post implantation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ProFlor Hernia implant | Device | Inguinal hernia repair |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ingrowth of Newly Formed Nervous Elements Within Hernia Implant ProFlor | Post-operative assessment of neonervegenesis within hernia implant ProFlor at short, mid and long term post-implantation | 3 weeks until 8 months post-implantation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Giuseppe Amato, MD | University of Cagliari | Principal Investigator |
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| 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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Tissue specimen and histological records upon request
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from actual date until december 2021
personal contact
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| ID | Title | Description |
|---|---|---|
| FG000 | Neonervegenesis in ProFlor Hernia Implant in the Short Term | Determining presence and level of maturation of nervous structures in the hernia implant ProFlor at 3-5 weeks post-implantation |
| FG001 | Neonervegenesis in ProFlor Hernia Implant in the Mid Term | Determining presence and level of maturation of nervous structures in the hernia implant ProFlor at 3-4 months post-implantation |
| FG002 | Neonervegenesis in ProFlor Hernia Implant in the Long Term | Determining presence and level of maturation of nervous structures in the hernia implant ProFlor at 6-8 months post-implantation |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Inguinal hernia patients operated with ProFlor who needed further surgery in the previously operated groin for various pathologies
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| ID | Title | Description |
|---|---|---|
| BG000 | Short Term Post-implantation | Determining presence and level of maturation of nervous structures in the hernia implant ProFlor at 3-5 weeks post-implantation |
| BG001 | Mid Term Post-implantation |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Ingrowth of Newly Formed Nervous Elements Within Hernia Implant ProFlor | Post-operative assessment of neonervegenesis within hernia implant ProFlor at short, mid and long term post-implantation | Patients who underwent inguinal hernia repair with ProFlor | Posted | Mean | Standard Deviation | μm^2 | 3 weeks until 8 months post-implantation |
|
1 year
All participant underwent biopsy from the implanted prosthesis. Being the prosthesis positioned in the inguinal area outside of the abdominal cavity, this minimally invasive procedure produces no risks of mortality. Also risks for serious adverse events are nullified because the tissue removal do not involve any vital organs
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Short Term Post-implantation | Determining presence and level of maturation of nervous structures in the hernia implant ProFlor at 3-5 weeks post-implantation |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof. Dr. Giuseppe Amato | University of Cagliari | 337963197 | amatomed@gmail.com |
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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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| 30318605 | Background | Amato G, Romano G, Puleio R, Agrusa A, Goetze T, Gulotta E, Gordini L, Erdas E, Calo P. Neomyogenesis in 3D Dynamic Responsive Prosthesis for Inguinal Hernia Repair. Artif Organs. 2018 Dec;42(12):1216-1223. doi: 10.1111/aor.13286. Epub 2018 Oct 14. |
| 32169570 | Result | Amato G, Agrusa A, Puleio R, Calo P, Goetze T, Romano G. Neo-nervegenesis in 3D dynamic responsive implant for inguinal hernia repair. Qualitative study. Int J Surg. 2020 Apr;76:114-119. doi: 10.1016/j.ijsu.2020.02.046. Epub 2020 Mar 10. |
Determining presence and level of maturation of nervous structures in the hernia implant ProFlor at 3-4 months post-implantation
| BG002 | Long Term Post-implantation | Determining presence and level of maturation of nervous structures in the hernia implant ProFlor at 6-8 months post-implantation |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG002 | Long Term Post-implantation | Determining presence and level of maturation of nervous structures in the hernia implant ProFlor at 6-8 months post implantation |
|
|
|
| 0 |
| 4 |
| 0 |
| 4 |
| 0 |
| 4 |
| EG001 | Mid Term Post-implantation | Determining presence and level of maturation of nervous structures in the hernia implant ProFlor at 3-4 months post-implantation | 0 | 5 | 0 | 5 | 0 | 5 |
| EG002 | Long Term Post-implantation | Determining presence and level of maturation of nervous structures in the hernia implant ProFlor at 6-8 months post-implantation | 0 | 6 | 0 | 6 | 0 | 6 |
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| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|