Randomized clinical trial of self-gripping mesh versus sutured mesh for Lichtenstein hernia repair.

Abstract

Many patients develop discomfort after open repair of a groin hernia. It was hypothesized that suture fixation of the mesh is a cause of these symptoms. This patient- and assessor-blinded randomized multicentre clinical trial compared a self-gripping mesh (Parietene Progrip(®)) and sutured mesh for open primary repair of uncomplicated inguinal hernia by the Lichtenstein technique. Patients were assessed before surgery, on the day of operation, and at 1 and 12 months after surgery. The primary endpoint was moderate or severe symptoms after 12 months, including a combination of chronic pain, numbness and discomfort. The intention-to-treat population comprised 163 patients with self-gripping mesh and 171 with sutured mesh. The 12-month prevalence of moderate or severe symptoms was 17·4 and 20·2 per cent respectively (P = 0·573). There were no significant differences between the groups in postoperative complications (33·7 versus 40·4 per cent; P = 0·215), rate of recurrent hernia within 1 year (1·2 per cent in both groups) or quality of life. The avoidance of suture fixation using a self-gripping mesh was not accompanied by a reduction in chronic symptoms after inguinal hernia repair. NCT00815698 (http://www.clinicaltrials.gov).