NCT06556498

Progrip Versus ProFlor: Two Fixation Free Devices for Laparoscopic Inguinal Hernia Repair

Progrip Versus ProFlor: Two Fixation Free Devices for Laparoscopic Inguinal Hernia Repair: A Randomized Clinical Trial: The ProPro Study

• Status: Enrolling By Invitation
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: University of Palermo · Academic / Other
• Sex: Male
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

there are currently two methods for fixation free laparoscopic inguinal hernia repair specifically based on the intrinsic properties of the device used. The Progrip mesh technique leaves the hernia orifice patent and relies on the established principle of strengthening the groin through scar tissue incorporation induced by foreign body reaction. In contrast, the ProFlor concept introduces a 3D dynamic regenerative scaffold that permanently obliterates the defect and regenerates the herniated inguinal barrier. This report presents the outcomes of laparoscopic techniques employing Progrip and ProFlor in randomized clinical trial. The results of this clinical study may have the potential to pave the way for innovative advancements in hernia repair techniques.

Conditions

• Hernia, Inguinal
• Laparoscopic Surgery

Interventions

Type	Name	Description
PROCEDURE	Proflor group	evaluate the surgical outcomes of patients underwent to laparoscopic inguinal hernia repair with Proflor mesh.
PROCEDURE	Progrip group	evaluate the surgical outcomes of patients underwent to laparoscopic inguinal hernia repair with Progrip mesh.

Timeline

• Start date: 2021-01-01
• Primary completion: 2023-12-31
• Completion: 2025-12-31
• First posted: 2024-08-16
• Last updated: 2024-08-16

Locations

1 site across 1 country: Italy

Regulatory

• FDA-regulated device study