Laparoscopic Hernia Defect Obliteration With ProFlor-E

University of Cagliari

Status: Completed

Conditions: Inguinal Hernia

Treatments: Device: ProFlor laparoscopic technique

Study type: Interventional

Funder types: Other

Identifiers

NCT04718298

Laparoscopic ProFlor approach

Details and patient eligibility

About

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

Full 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.

Enrollment: 50 patients

Sex: Male

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• ASA >4 patients

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Inguinal hernia repair laparoscopic

Experimental group

Description:

recurrent inguinal hernia after open repair or bilateral hernia patients

Treatment:

Device: ProFlor laparoscopic technique