Status:
COMPLETED
Polypropylene Mesh Versus Polytetrafluoroethylene (PTFE) Mesh in Inguinal Hernia Repair
Lead Sponsor:
University of Roma La Sapienza
Conditions:
Physical Function
Pain
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief 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.
Eligibility Criteria
Inclusion
- \>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
- 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
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2015
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT01141335
Start Date
September 1 2009
End Date
September 1 2015
Last Update
November 22 2016
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
UO Oneday-day Surgery, Azienda Ospedaliera Sant'Andrea
Rome, Italy, Italy, 00189