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

Not Applicable

• Conditions: Hernia, Inguinal
• Interventions: 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

• Registration Number: NCT02011698
• Lead Sponsor: Ospedale di Circolo - Fondazione Macchi

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 Timeline

• Study Start: 2013-10
• Status Verified: 2013-12
• Study First Submitted: 2013-12-10
• Study First Submitted QC: 2013-12-12
• Last Update Submitted: 2013-12-12
• Study First Posted: 2013-12-13
• Last Update Posted: 2013-12-13
• Primary Completion: 2015-10
• Study Completion: 2016-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 900

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
absorbable sutures	Lichtenstein technique groin hernia repair with mesh. Use of absorbale sutures for mesh fixation	mesh fixation with absorbable sutures in lichtenstein anterior inguinal herniorrhaphy
non absorbable sutures	Lichtenstein technique groin hernia repair with mesh. Use of non absorbable sutures for mesh fixation	mesh fixation with non absorbable sutures in lichtenstein anterior inguinal herniorrhaphy. This is the method to be considered the standard of care thus far.
fibrin biological glue	Lichtenstein technique groin hernia repair with mesh. Use of fibrin biological glue for mesh fixation	mesh fixation with fibrin biological glue in lichtenstein anterior inguinal herniorrhaphy

Primary Outcome Measures

Name	Time	Method
rate of recurrence	1 year

Secondary Outcome Measures

Name	Time	Method
rate of chronic pain	1 year

Trial Locations

Locations (1)

Azienda Ospedaliera Ospedale di Circolo e Fondazione Macchi; 🇮🇹 Varese, Va, Italy