Polypropylene Mesh Versus Polytetrafluoroethylene (PTFE) Mesh in 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

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2015-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Physical Function Pain Hernia Wound Infection Postoperative Complication Recurrence

Keywords

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shrinkage postoperative pain and discomfort

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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PTFE mesh

A Lichtenstein tension-free hernioplasty is performed using PTFE mesh

Group Type EXPERIMENTAL

Infinit® PTFE mesh (WL Gore)

Intervention Type DEVICE

A Lichtenstein tension-free hernioplasty is performed using a PTFE mesh will be fixed by sutures in PTFE 2/0.

polypropylene mesh

A Lichtenstein tension-free hernioplasty is performed using polypropylene mesh

Group Type ACTIVE_COMPARATOR

polypropylene mesh

Intervention Type DEVICE

A Lichtenstein tension-free hernioplasty is performed using a polypropylene mesh will be fixed by sutures in Polypropylene 2/0.

Interventions

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polypropylene mesh

A Lichtenstein tension-free hernioplasty is performed using a polypropylene mesh will be fixed by sutures in Polypropylene 2/0.

Intervention Type DEVICE

Infinit® PTFE mesh (WL Gore)

A Lichtenstein tension-free hernioplasty is performed using a PTFE mesh will be fixed by sutures in PTFE 2/0.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Francesco Saverio Mari

MD

Responsibility Role PRINCIPAL_INVESTIGATOR