Laparoscopic Fixation Free Obliteration of Inguinal Hernia Defect With the 3D Dynamic Responsive Implant ProFlor-E - Feasibility Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Inguinal Hernia
- Sponsor
- University of Cagliari
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Feasibility of inguinal hernia defect obliteration with ProFlor
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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.
Investigators
Giuseppe Amato
Consultant Professor
University of Cagliari
Eligibility Criteria
Inclusion Criteria
- •patients with recurrent inguinal hernia already repaired with open approach or suffering by bilateral inguinal hernias
Exclusion Criteria
- •ASA \>4 patients
Outcomes
Primary Outcomes
Feasibility of inguinal hernia defect obliteration with ProFlor
Time Frame: intraoperative
Effectiveness of the laparoscopic procedure for inguinal hernia repair with ProFlor
Secondary Outcomes
- Postoperative pain(from early stage until 18 months postop)