Chronic Pain Clinical Trial
Official title:
A Multicenter Prospective Randomized Trial on Chronic Pain After Inguinal Hernia Repair Using a Selfgrip-mesh
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.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
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