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Clinical Trials/NCT02011698
NCT02011698
Unknown
Not Applicable

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 Macchi1 site in 1 country900 target enrollmentOctober 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hernia, Inguinal
Sponsor
Ospedale di Circolo - Fondazione Macchi
Enrollment
900
Locations
1
Primary Endpoint
rate of recurrence
Last Updated
12 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
October 2013
End Date
October 2016
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Ospedale di Circolo - Fondazione Macchi
Responsible Party
Principal Investigator
Principal Investigator

Lorenzo Latham, MD

MD

Ospedale di Circolo - Fondazione Macchi

Eligibility Criteria

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

Outcomes

Primary Outcomes

rate of recurrence

Time Frame: 1 year

Secondary Outcomes

  • rate of chronic pain(1 year)

Study Sites (1)

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