Inguinal Hernia
Conditions
Keywords
Hernia implants, Biologic response, Neo-nervegenesis, Regenerative scaffold
Brief summary
The investigation is aimed at specifically demonstrating the ingrowth of newly formed nervous elements within a 3D dynamic responsive implant for inguinal hernia repair.
Detailed description
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.
Interventions
DEVICEProFlor Hernia implant
Inguinal hernia repair
Sponsors
University of Cagliari
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Patients who underwent inguinal hernia repair with the prosthetic device named ProFlor * Patients undergoing recurrent inguinal hernia repair after primary repair with the prosthetic device named ProFlor * Patients undergoing surgical procedure in the groin area after inguinal hernia repair with the prosthetic device named ProFlor
Exclusion criteria
* Patients who underwent inguinal hernia repair with conventional flat meshes
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ingrowth of Newly Formed Nervous Elements Within Hernia Implant ProFlor | 3 weeks until 8 months post-implantation | Post-operative assessment of neonervegenesis within hernia implant ProFlor at short, mid and long term post-implantation |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Short Term Post-implantation Determining presence and level of maturation of nervous structures in the hernia implant ProFlor at 3-5 weeks post-implantation | 4 |
| Mid Term Post-implantation Determining presence and level of maturation of nervous structures in the hernia implant ProFlor at 3-4 months post-implantation | 5 |
| Long Term Post-implantation Determining presence and level of maturation of nervous structures in the hernia implant ProFlor at 6-8 months post-implantation | 6 |
| Total | 15 |
Baseline characteristics
| Characteristic | Mid Term Post-implantation | Long Term Post-implantation | Short Term Post-implantation | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 1 Participants | 1 Participants | 4 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants | 5 Participants | 3 Participants | 11 Participants |
| Age, Continuous | 59.6 years STANDARD_DEVIATION 4871 | 61.5 years STANDARD_DEVIATION 4881 | 53.6 years STANDARD_DEVIATION 4561 | 58.23 years STANDARD_DEVIATION 4581 |
| Race and Ethnicity Not Collected | — | — | — | 0 Participants |
| Region of Enrollment Italy | 5 Participants | 6 Participants | 4 Participants | 15 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 5 Participants | 6 Participants | 4 Participants | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 4 | 0 / 5 | 0 / 6 |
| other Total, other adverse events | 0 / 4 | 0 / 5 | 0 / 6 |
| serious Total, serious adverse events | 0 / 4 | 0 / 5 | 0 / 6 |
Outcome results
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
Time frame: 3 weeks until 8 months post-implantation
Population: Patients who underwent inguinal hernia repair with ProFlor
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Short Term Post Implantation | Ingrowth of Newly Formed Nervous Elements Within Hernia Implant ProFlor | 999.75 μm^2 | Standard Deviation 113.32 |
| Mid Term Post Implantation | Ingrowth of Newly Formed Nervous Elements Within Hernia Implant ProFlor | 1044 μm^2 | Standard Deviation 695.95 |
| Long Term Post-implantation | Ingrowth of Newly Formed Nervous Elements Within Hernia Implant ProFlor | 2094 μm^2 | Standard Deviation 490.82 |
p-value: 0.028t-test, 2 sided