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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

900 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2016-10-31

Brief Summary

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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

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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

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Hernia, Inguinal

Keywords

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Groin hernia lichtenstein herniorrhaphy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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absorbable sutures

mesh fixation with absorbable sutures in lichtenstein anterior inguinal herniorrhaphy

Group Type EXPERIMENTAL

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

Intervention Type PROCEDURE

non absorbable sutures

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

Group Type ACTIVE_COMPARATOR

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

Intervention Type PROCEDURE

fibrin biological glue

mesh fixation with fibrin biological glue in lichtenstein anterior inguinal herniorrhaphy

Group Type EXPERIMENTAL

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

Intervention Type PROCEDURE

Interventions

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

Intervention Type PROCEDURE

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

Intervention Type PROCEDURE

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

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Lorenzo Latham, MD

MD

Responsibility Role PRINCIPAL_INVESTIGATOR