NCT00580177

PHS, Lichtenstein Mesh, and PerFixPlug for Primary Inguinal Hernia Repair - 3 Years Results

Prolene Hernia System, Lichtenstein Mesh, and Plug-and-Patch for Primary Inguinal Hernia Repair - Three Year Outcome of a Prospective Randomised Controlled Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 472 (actual)
• Sponsor: Göteborg University · Academic / Other
• Sex: Male
• Age: 30 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Three different techniques for the surgical repair of groin hernias are compared. Focus has been set on operation times, time to full return of functional abilities like walking in stairs etc, and if any technique has more complications than the others. Three years results are presented in the study.

Detailed description

Dissection requirements differ between various methods for inguinal hernia repair, which may effect operation times, pain response and possibly recovery time. The objectives of this study were to establish if any differences concerning these aspects could be detected after three principally different techniques for primary inguinal hernia repair. 472 men between 30 and 75 years with primary inguinal hernias were included in a prospective controlled study and randomised to Lichtenstein mesh (L), PerFix Plug® (P) or the Prolene® Hernia System (PHS) procedure. All patients were seen and data were collected after 2 weeks, 3 months, 1 year, and 3 years.

Conditions

• Hernia, Inguinal

Interventions

Type	Name	Description
PROCEDURE	Lichtenstein mesh	The different techniques are compared and evaluated according to primary and secondary objectives.
PROCEDURE	PerFix Plug®	The different techniques are compared and evaluated according to primary and secondary objectives.
PROCEDURE	Prolene® Hernia System	The different techniques are compared and evaluated according to primary and secondary objectives.

Timeline

• Start date: 2000-01-01
• Primary completion: 2005-07-01
• Completion: 2005-07-01
• First posted: 2007-12-24
• Last updated: 2007-12-24

Locations

1 site across 1 country: Sweden