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

NCT01141335 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2016-11-22

No results posted yet for this study

Summary

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.

Conditions

  • Physical Function
  • Pain
  • Hernia
  • Wound Infection
  • Postoperative Complication
  • Recurrence

Interventions

DEVICE

polypropylene mesh

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

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.

Sponsors & Collaborators

  • University of Roma La Sapienza

    lead OTHER

Principal Investigators

  • Luigi Masoni, Dr. · Azienda Ospedaliera Sant'Andrea, Rome, Italy

  • Francesco Saverio Mari, Dr. · Azienda Ospedaliera Sant'Andrea, Rome, Italy

  • Antonio Brescia, Prof. · Azienda Ospedaliera Sant'Andrea, Rome, Italy

  • Giuseppe R Nigri, Dr. · Azienda Ospedaliera Sant'Andrea, Rome, Italy

  • Francesco Favi, Dr · Azienda Ospedaliera Sant'Andrea, Rome, Italy

  • Andrea Milillo, Dr. · Azienda Ospedaliera Sant'Andrea, Rome, Italy

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2010-09-30
Completion
2015-09-30

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01141335 on ClinicalTrials.gov