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Comparison of Three Meshes in Lichtenstein Hernia Repair

A Single-surgeon Randomized Study Comparing Three Composite Meshes on Chronic Pain After Lichtenstein Hernia Repair in Local Anesthesia

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01295437
Acronym
Lichtenstein
Enrollment
300
Registered
2011-02-14
Start date
2003-03-31
Completion date
2011-01-31
Last updated
2011-02-14

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

Conditions

Chronic Pain, Recurrences

Keywords

inguinal hernia, Lichtenstein hernioplasty, chronic pain

Brief summary

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).

Detailed 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.

Interventions

DEVICEVypro II mesh

partly absorbable mesh

DEVICEPremilene LP

lightweight mesh

DEVICEPremilene mesh

A conventional polypropylene mesh (82 g/m2)

Sponsors

Mikkeli Central Hospital
CollaboratorOTHER
Kuopio University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Presence of chronic pain5 yearsPain scores were measured by using a visual analoque scale.

Secondary

MeasureTime frameDescription
Presence of recurrences5 yearsRecurrence of inguinal hernias after Lichtenstein hernioplasty was studies during clinical and ultrasound examination

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 24, 2026