Neo-nervegenesis in Inguinal Hernia Implant ProFlor

Not Applicable

Completed

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Short term post inguinal hernia repair wit ProFlor	ProFlor Hernia implant	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	ProFlor Hernia implant	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	ProFlor Hernia implant	Determining presence and level of maturation of nervous structures in the hernia implant named ProFlor at 6-8 months post implantation

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures