Comparison of Three Meshes in Lichtenstein Hernia Repair

Chronic Pain Clinical Trial

— Lichtenstein  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01295437
• Other study ID #: Lichtenstein hernia repair
• Secondary ID: Lichtenstein
• Status: Completed
• Phase: N/A
• First received: February 11, 2011
• Last updated: February 11, 2011
• Start date: March 2003
• Est. completion date: January 2011

Study information

• Verified date: February 2011
• Source: Kuopio University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Kuopio University Hospital, Ethics Committee
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: January 2011
• Est. primary completion date: January 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Pain
• Recurrence
• Recurrences

Intervention

Device:
• Vypro II mesh
partly absorbable mesh
• Premilene LP
lightweight mesh
• Premilene mesh
A conventional polypropylene mesh (82 g/m2)

Locations

Country	Name	City	State
Finland	Hannu Paajanen	Kuopio

Sponsors (2)

Lead Sponsor	Collaborator
Kuopio University Hospital	Mikkeli Central Hospital, Mikkeli, Finland

Country where clinical trial is conducted

Finland, 

References & Publications (1)

Paajanen H. A single-surgeon randomized trial comparing three composite meshes on chronic pain after Lichtenstein hernia repair in local anesthesia. Hernia. 2007 Aug;11(4):335-9. Epub 2007 May 10. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence of chronic pain	Pain scores were measured by using a visual analoque scale.	5 years	Yes
Secondary	Presence of recurrences	Recurrence of inguinal hernias after Lichtenstein hernioplasty was studies during clinical and ultrasound examination	5 years	Yes