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NCT04718298 Clinical Trial

Laparoscopic Hernia Defect Obliteration With ProFlor-E

Inguinal Hernia Clinical Trial

Official title:
Laparoscopic Fixation Free Obliteration of Inguinal Hernia Defect With the 3D Dynamic Responsive Implant ProFlor-E - Feasibility Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04718298
Other study ID # Laparoscopic ProFlor approach
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 1, 2019
Est. completion date June 1, 2021

Study information
Verified date September 2021
Source University of Cagliari
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This feasibility study highlights the features of the 3D dynamic responsive prosthesis ProFlor-E® for fixation free obliteration of inguinal hernia defect

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.

Recruitment information / eligibility
Status Completed
Enrollment 50
Est. completion date June 1, 2021
Est. primary completion date June 1, 2021
Accepts healthy volunteers No
Gender Male
Age group 18 Years to 85 Years
Eligibility Inclusion Criteria: - patients with recurrent inguinal hernia already repaired with open approach or suffering by bilateral inguinal hernias Exclusion Criteria: - ASA >4 patients

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• ProFlor laparoscopic technique
Inguinal hernia repair laparoscopic

Locations
Country Name City State
Italy University of Palermo Palermo Please Select

Sponsors (1)
Lead Sponsor Collaborator
University of Cagliari

Country where clinical trial is conducted

Italy, 

References & Publications (3)

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. — View Citation

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. — View Citation

Amato G, Romano G, Goetze T, Cicero L, Gulotta E, Calò PG, Agrusa A Fixation free inguinal hernia repair with the 3D dynamic responsive prosthesis ProFlor: Features, procedural steps and long-term results. International Journal of Surgery Open 2019; 21:34-4

Outcome
Type Measure Description Time frame Safety issue
Primary Feasibility of inguinal hernia defect obliteration with ProFlor Effectiveness of the laparoscopic procedure for inguinal hernia repair with ProFlor intraoperative
Secondary Postoperative pain assessment of postoperative pain through Visual Analogue Scale from early stage until 18 months postop
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