Comparison of Three Meshes in Lichtenstein Hernia Repair

Kuopio University Hospital

Status: Completed

Conditions: Recurrences; Chronic Pain

Treatments: Device: Premilene mesh; Device: Vypro II mesh; Device: Premilene LP

Study type: Interventional

Funder types: Other

Identifiers

NCT01295437

Lichtenstein hernia repair

Lichtenstein (Other Identifier)

Details and patient eligibility

About

Chronic pain may be a long-term problem after inguinal Lichtenstein hernioplasty. The aim of this study was to compare long-term results of hernioplasty using three different meshes (partly absorbable, lightweight polypropylene and thick polypropylene mesh).

Full description

Inguinal hernioplasty was performed under local anesthesia in 300 patients in day-case surgery by the same surgeon and exactly by the same surgical technique. The patients were randomized to receive either a partly polypropylene-polyglactin mesh (Vypro II, 100 hernias), a lightweight polypropylene mesh (Premilene LP, 100 hernias) or a conventional densely woven polypropylene mesh (Premilene, 100 hernias). Pain, patients discomfort and recurrences of hernias were carefully followed 5 years after surgery.

Enrollment: 300 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• uni-or bilateral primary or recurrent inguinal hernia
• patients age >18yrs

Exclusion criteria

• previous mesh hernioplasty
• femoral hernia
• emergency operation
• allergy to polypropylene

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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300 participants in 3 patient groups, including a placebo group

Vypro II mesh

Active Comparator group

Description:

A partly absorbable polypropylene-polyglactin mesh (50g/m2).

Treatment:

Device: Vypro II mesh

Premilene LP

Active Comparator group

Description:

A lightweight polypropylene mesh (55 g/m2)

Treatment:

Device: Premilene LP

Premilene mesh

Placebo Comparator group

Description:

A conventional polypropylene mesh (82 g/m2)

Treatment:

Device: Premilene mesh