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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

PHASE4

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-01

Study Completion Date

2025-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Hernia, Inguinal Laparoscopic Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

we use progrip mesh and proflor mesh in different arms of patients

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Compared progrip mesh with proflor mesh

Study Groups

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ProFlor group

patients underwent to laparoscopic hernia repair with the use of ProFlor mesh

Group Type ACTIVE_COMPARATOR

Proflor group

Intervention Type PROCEDURE

evaluate the surgical outcomes of patients underwent to laparoscopic inguinal hernia repair with Proflor mesh.

Progrip group

patients underwent to laparoscopic hernia repair with the use of Progrip mesh

Group Type ACTIVE_COMPARATOR

Progrip group

Intervention Type PROCEDURE

evaluate the surgical outcomes of patients underwent to laparoscopic inguinal hernia repair with Progrip mesh.

Interventions

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Proflor group

evaluate the surgical outcomes of patients underwent to laparoscopic inguinal hernia repair with Proflor mesh.

Intervention Type PROCEDURE

Progrip group

evaluate the surgical outcomes of patients underwent to laparoscopic inguinal hernia repair with Progrip mesh.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* bilateral inguinal hernia

Exclusion Criteria

* Recurrent inguinal hernia
* Incarcerated inguinal hernia
* Hernia not in the inguinal area
* Signs of obvious local or systemic infection
* ASA score \> 4
* Presenting with unstable angina or NYHA class of IV
* Pregnant
* Active drug user
* Immunosuppression, chemotherapy
* Chronic renal insufficiency
* Abdominal ascites
* Infection in area of the surgical field
* BMI \>34

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No