Polypropylene Mesh Versus Polytetrafluoroethylene (PTFE) Mesh in Inguinal Hernia Repair

University of Roma La Sapienza

Status and phase: Completed; Phase 4

Conditions: Physical Function; Postoperative Complication; Hernia; Pain; Recurrence; Wound Infection

Treatments: Device: polypropylene mesh; Device: Infinit® PTFE mesh (WL Gore)

Study type: Interventional

Funder types: Other

Identifiers

NCT01141335

DS-002

Details and patient eligibility

About

To evaluate the safety and efficacy of the Lichtenstein's hernioplasty using Infinit® PTFE Mesh, and to compare it with the traditional Lichtenstein procedure performed with polypropylene mesh.

Enrollment: 70 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• >18 <65 years of age
• Diagnosis of Unilateral inguinal hernia
• Able to provide written consent
• BMI < 35
• ASA I-II patients
• Non-complicated primary inguinal hernia performed in non-emergency setting and repaired with a Lichtenstein's hernioplasty
• Informed consent

Exclusion criteria

• Recurrent hernias
• Incarcerated hernia
• BMI > 35
• ASA III-IV patients
• Any condition preventing a correct evaluation of pain (non-cooperative patient, blind patient, drug addicted)
• Hypersensitivity to any drug in study
• Patients with an intra-operative findings of different pathology will be excluded from the study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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70 participants in 2 patient groups

PTFE mesh

Experimental group

Description:

A Lichtenstein tension-free hernioplasty is performed using PTFE mesh

Treatment:

Device: Infinit® PTFE mesh (WL Gore)

polypropylene mesh

Active Comparator group

Description:

A Lichtenstein tension-free hernioplasty is performed using polypropylene mesh

Treatment:

Device: polypropylene mesh