Laparoscopic Hernia Defect Obliteration With ProFlor-E

Overview

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

Full Title of Study: “Laparoscopic Fixation Free Obliteration of Inguinal Hernia Defect With the 3D Dynamic Responsive Implant ProFlor-E – Feasibility Study”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Sequential Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 1, 2021

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

  • Device: ProFlor laparoscopic technique
    • Inguinal hernia repair laparoscopic

Arms, Groups and Cohorts

  • Experimental: Inguinal hernia repair laparoscopic
    • recurrent inguinal hernia after open repair or bilateral hernia patients

Clinical Trial Outcome Measures

Primary Measures

  • Feasibility of inguinal hernia defect obliteration with ProFlor
    • Time Frame: intraoperative
    • Effectiveness of the laparoscopic procedure for inguinal hernia repair with ProFlor

Secondary Measures

  • Postoperative pain
    • Time Frame: from early stage until 18 months postop
    • assessment of postoperative pain through Visual Analogue Scale

Participating in This Clinical Trial

Inclusion Criteria

  • patients with recurrent inguinal hernia already repaired with open approach or suffering by bilateral inguinal hernias Exclusion Criteria:

  • ASA >4 patients

Gender Eligibility: Male

Minimum Age: 18 Years

Maximum Age: 85 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Cagliari
  • Provider of Information About this Clinical Study
    • Principal Investigator: Giuseppe Amato, Consultant Professor – University of Cagliari
  • Overall Official(s)
    • Giuseppe Amato, MD, Principal Investigator, University of Cagliari – University of Palermo
  • Overall Contact(s)
    • Giuseppe Amato, MD, 337963197, amatomed@gmail.com

References

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.

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.

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

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