Trials / Unknown
UnknownNCT02011698
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
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 900 (estimated)
- Sponsor
- Ospedale di Circolo - Fondazione Macchi · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Lichtenstein technique groin hernia repair with mesh. Use of absorbale sutures for mesh fixation | |
| PROCEDURE | Lichtenstein technique groin hernia repair with mesh. Use of non absorbable sutures for mesh fixation | |
| PROCEDURE | Lichtenstein technique groin hernia repair with mesh. Use of fibrin biological glue for mesh fixation |
Timeline
- Start date
- 2013-10-01
- Primary completion
- 2015-10-01
- Completion
- 2016-10-01
- First posted
- 2013-12-13
- Last updated
- 2013-12-13
Locations
1 site across 1 country: Italy
Source: ClinicalTrials.gov record NCT02011698. Inclusion in this directory is not an endorsement.