Skip to content

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

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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02011698
Enrollment
900
Registered
2013-12-13
Start date
2013-10-31
Completion date
2016-10-31
Last updated
2013-12-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hernia, Inguinal

Keywords

Groin hernia, lichtenstein herniorrhaphy

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

Interventions

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

Sponsors

Ospedale di Circolo - Fondazione Macchi
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
rate of recurrence1 year

Secondary

MeasureTime frame
rate of chronic pain1 year

Countries

Italy

Contacts

Primary Contactlorenzo LL latham, md
lorenzo.latham@ospedale.varese.it0332278348

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026