NCT00820131

Chronic Pain After Inguinal Hernia Repair

A Multicenter Prospective Randomized Trial on Chronic Pain After Inguinal Hernia Repair Using a Selfgrip-mesh

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 250 (estimated)
• Sponsor: Medical University of Vienna · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

Chronic pain after inguinal hernia repair has become a major concern. Although tension-free Lichtenstein technique is used and new lightweight meshes have been developed, still up to 40 % of patients complain of some kind of pain even one year after surgery. The necessity of mesh-fixation using sutures, could be causative. However, current data do not provide evidence whether suture fixation in Lichtenstein repair might be the reason for chronic postoperative pain. A newly developed selfgrip-mesh enables sutureless fixation of the mesh in open inguinal hernia repair. Hereby a polypropylene mesh is combined with a resorbable polylactic-acid gripping system. Thereby the rate of chronic postoperative pain could be decreased. Two techniques of inguinal hernia repair will be evaluated: 1. open anterior mesh repair using conventional Lichtenstein technique (sutures for mesh-fixation) 2. open anterior mesh repair using a selfgrip mesh (polylactic-acid gripping system for mesh fixation) Postoperative pain will be evaluated by visual analog scale and Mc Gill pain questionaire at the 10th day, as well as 3 and 15 months postoperatively.

Conditions

• Inguinal Hernia
• Chronic Pain

Interventions

Type	Name	Description
PROCEDURE	selfgrip mesh	inguinal hernia repair using a selfgrip mesh
PROCEDURE	lightweight mesh with suture fixation	inguinal hernia repair using a lightweight mesh with suture fixation

Timeline

• Start date: 2008-01-01
• Primary completion: 2013-01-01
• Completion: 2014-12-01
• First posted: 2009-01-09
• Last updated: 2014-12-09

Locations

7 sites across 1 country: Austria