Absorbable Sutures , Non Absorbable Sutures or Biologic Fibrin Glue for Protesic Mesh Fixing in Lichtenstein Technique for Primitive Groin Hernia Repair: a Randomized Prospective Multicentric Trial
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 900
- Locations
- 2
- Primary Endpoint
- rate of recurrence
Study Overview
Brief Summary
this study has the aim to analize the correlation between three different methods of mesh fixation ( using absorbable or non absorbable sutures or fibrin biological glue) and recurrance and chronic pain ,in the Lichtenstein anterior inguinal erniorrhaphy
Detailed Description
In the last decades the rate of recurrence in the anterior inguinal erniorraphy has been drastically lowered with the introduction of the mesh , on the other hand the rate of chronic pain is reported to be high in many papers.
The chronic pain influences the quality of life and what's more causes an increase in the social costs.
the classical Lichtenstein inguinal anterior erniorrhaphy , wich is the technique suggested by the international guidelines, expected to fix the mesh with non absorbable sutures .
The investigators would analyze the possible correlation between the method of mesh fixation and chronic pain keeping a lower rate of recurrence.
That said the primary endpoint in this study is the rate of recurrence and the secondary endpoint is the rate of chronic pain after lichtenstein anterior inguinal erniorrhaphy in the three different methods of fixation of the mesh
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •primitive inguinal hernia
- •age > 18 years old
- •compliancy to the study
Exclusion Criteria
- •reccurent inguinal hernia
- •age < 18 years old
- •refusal of the study
Outcomes
Primary Outcomes
rate of recurrence
Time Frame: 1 year
Secondary Outcomes
- rate of chronic pain(1 year)
Investigators
Lorenzo Latham, MD
MD
Ospedale di Circolo - Fondazione Macchi