Trials / Completed
CompletedNCT01295437
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
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 300 (actual)
- Sponsor
- Kuopio University Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years – 85 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Vypro II mesh | partly absorbable mesh |
| DEVICE | Premilene LP | lightweight mesh |
| DEVICE | Premilene mesh | A conventional polypropylene mesh (82 g/m2) |
Timeline
- Start date
- 2003-03-01
- Primary completion
- 2005-01-01
- Completion
- 2011-01-01
- First posted
- 2011-02-14
- Last updated
- 2011-02-14
Locations
1 site across 1 country: Finland
Source: ClinicalTrials.gov record NCT01295437. Inclusion in this directory is not an endorsement.