NCT01026935

The Outcome After Lichtenstein Operation vs. ProGrip Patch Repair of Inguinal Hernia

The Effect of Mesh Type on Pain After Surgery for Inguinal Hernia. Randomized Clinical Trial of Lichtenstein Operation With Sutured Polypropylene Patch or Self-adhesive ProGrip Patch.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 398 (actual)
• Sponsor: Helsinki University Central Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

For the present study, 400 consecutive men with unilateral primary inguinal hernia are randomized to Lichtenstein repair using either light weight polypropylene mesh (38g/m2) or light weight ProGrip mesh. ProGrip mesh adheres to tissues with polylactic micro hooks without suturing. The primary aim is to examine, whether the ProGrip mesh produces less pain than sutured polypropylene mesh. Secondary outcomes are operation time and convalescence as well as recurrence rate. ProGrip mesh is supposed to be faster to apply as no sutures are needed, which may compensate for its higher cost. The patients are blinded to which mesh they receive.

Conditions

• Inguinal Hernia
• Primary
• Unilateral

Interventions

Type	Name	Description
DEVICE	Open inguinal hernia repair	Altogether 400 patients are randomized to receive an open mesh repair with either sutured light weight mesh (38g/m2) or with a non-sutured light weight polypropylene mesh that adheres to tissues with polylactic micro hooks

Timeline

• Start date: 2008-02-01
• Primary completion: 2010-01-01
• Completion: 2011-01-01
• First posted: 2009-12-07
• Last updated: 2011-07-20

Locations

2 sites across 1 country: Finland