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

Ospedale di Circolo - Fondazione Macchi

Status: Unknown

Conditions: Hernia, Inguinal

Treatments: 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 absorbale sutures for mesh fixation; Procedure: Lichtenstein technique groin hernia repair with mesh. Use of fibrin biological glue for mesh fixation

Study type: Interventional

Funder types: Other

Identifiers

NCT02011698

Hernia-01

Details and patient eligibility

About

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

Full 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

Enrollment: 900 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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900 participants in 3 patient groups

absorbable sutures

Experimental group

Description:

mesh fixation with absorbable sutures in lichtenstein anterior inguinal herniorrhaphy

Treatment:

Procedure: Lichtenstein technique groin hernia repair with mesh. Use of absorbale sutures for mesh fixation

non absorbable sutures

Active Comparator group

Description:

mesh fixation with non absorbable sutures in lichtenstein anterior inguinal herniorrhaphy. This is the method to be considered the standard of care thus far.

Treatment:

Procedure: Lichtenstein technique groin hernia repair with mesh. Use of non absorbable sutures for mesh fixation

fibrin biological glue

Experimental group

Description:

mesh fixation with fibrin biological glue in lichtenstein anterior inguinal herniorrhaphy

Treatment:

Procedure: Lichtenstein technique groin hernia repair with mesh. Use of fibrin biological glue for mesh fixation