Status:
COMPLETED
Prospective Randomized Trial Comparing Lichtenstein's Repair of Inguinal Hernia With Polypropylene Mesh Versus Surgisis
Lead Sponsor:
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Conditions:
Hernia, Inguinal
Eligibility:
MALE
18+ years
Phase:
PHASE4
Brief Summary
To evaluate the safety and efficacy of the Lichtenstein's hernioplasty using the Surgisis ES soft tissue graft, as a mesh, and to compare it with the traditional Lichtenstein procedure performed with ...
Detailed Description
Inclusion and Exclusion Criteria Inclusion criteria: * Male, adult patients * ASA I-III patients * Non-complicated primary inguinal hernia (classification according to Gilbert I-II-III-IV-V-VI, modi...
Eligibility Criteria
Inclusion
- Male, adult patients
- ASA I-III patients
- Non-complicated primary inguinal hernia (classification according to Gilbert I-II-III-IV-V-VI, modified. according to Rutkow and Robbins) performed in non-emergency setting and repaired with a Lichtenstein's hernioplasty using polypropylene or Surgisis mesh
- Informed consent
Exclusion
- Recurrent hernias
- 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 :
January 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2003
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT00614419
Start Date
January 1 2003
End Date
December 1 2003
Last Update
March 18 2021
Active Locations (1)
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1
St.Orsola-Malpighi University Hospital
Bologna, Italy, 40138