Clinical Trials Directory

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

TypeNameDescription
PROCEDURELichtenstein technique groin hernia repair with mesh. Use of absorbale sutures for mesh fixation
PROCEDURELichtenstein technique groin hernia repair with mesh. Use of non absorbable sutures for mesh fixation
PROCEDURELichtenstein 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.