MEsh FIxation STudy in Laparoendoscopic Repair of M3 Inguinal Hernias: multicenter, double-blind, randomized controlled trial - MEFISTO Trial.

Abstract

Objective: To evaluate the efficacy of non-fixation versus fixation of meshes in laparoendoscopic repair of M3 inguinal hernias in terms of recurrence, postoperative pain, and surgical complications.

Summary background data: International guidelines recommend mesh fixation for large M3 inguinal hernias during laparoendoscopic repairs due to high recurrence rates. However, emerging experimental and registry data suggest that anatomically shaped, rigid and three-dimensional meshes may maintain stability without fixation. This study aimed to address this knowledge gap through a multicenter randomized controlled trial.

Methods: The MEFISTO Trial is a prospective, multicenter, double-blind, randomized controlled trial conducted in 12 surgical centers. A total of 204 patients with M3 inguinal hernias were randomized into two groups: a non-fixation group using three-dimensional, rigid, anatomical meshes. Fixation group using flat lightweight meshes fixed with tissue adhesive. The primary outcome was the recurrence rate at 12 months. The secondary outcomes included postoperative pain (Visual Analog Scale) and surgical site occurrence. Data were analyzed using appropriate statistical methods for non-inferiority studies.

Results: The recurrence rate at 12 months was 3.1% and 2.1% in the non-fixation and fixation groups respectively (P = 0.6847). No differences were observed in pain at discharge, 7-10 days post-surgery, or 12 months post-surgery. No significant differences were found in surgical complications or operative times between groups.

Conclusions: Non-fixation of three-dimensional meshes is non-inferior to fixation of flat lightweight meshes for M3 inguinal hernia repair. These findings support the potential revision of international hernia management guidelines to incorporate non-fixation approaches with appropriate mesh types.