Inguinal Hernia
Conditions
Keywords
Inguinal hernia, Laparoscopic inguinal hernia repair, Inguinal hernia defect obliteration, Fixation free hernia repair, Regenerative scaffolds
Brief summary
This feasibility study highlights the features of the 3D dynamic responsive prosthesis ProFlor-E® for fixation free obliteration of inguinal hernia defect
Detailed description
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.
Interventions
DEVICEProFlor laparoscopic technique
Inguinal hernia repair laparoscopic
Sponsors
University of Cagliari
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
feasibility study
Eligibility
Sex/Gender
MALE
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* patients with recurrent inguinal hernia already repaired with open approach or suffering by bilateral inguinal hernias
Exclusion criteria
* ASA \>4 patients
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of inguinal hernia defect obliteration with ProFlor | intraoperative | Effectiveness of the laparoscopic procedure for inguinal hernia repair with ProFlor |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative pain | from early stage until 18 months postop | assessment of postoperative pain through Visual Analogue Scale |
Countries
Italy
Outcome results
None listed