Related Experiment Video
Updated: Jun 15, 2025
Application of a New Mesh Fixation Method in Laparoscopic Incisional Hernia Repair
Published on: December 23, 2022
MEsh FIxation STudy in Laparoendoscopic Repair of M3 Inguinal Hernias: Multicenter, Double-blind, Randomized
Mateusz Zamkowski1,2, Maciej Ś Mietański1,3, Paula Franczak4
1General Surgery and Hernia Center, Swissmed Hospital, Gdańsk, Poland.
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.
Background:
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 (3D) meshes may maintain stability without fixation. This study aimed to address this knowledge gap through a multicenter randomized controlled trial.
Methods:
The MEsh FIxation STudy 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 2 groups: a "non-fixation" group using 3D, rigid, anatomic 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 noninferiority 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 to 10 days postsurgery, or 12 months postsurgery. No significant differences were found in surgical complications or operative times between groups.
Conclusions:
Non-fixation of 3D meshes is noninferior 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.
Insights
Non-fixation of 3D meshes is as effective as mesh fixation for M3 inguinal hernia repair, showing similar recurrence rates and postoperative pain. This supports updated guidelines for hernia management.
Area of Science:
- Laparoscopic surgery
- Hernia repair
- Surgical innovation
Background:
- Current guidelines recommend mesh fixation for M3 inguinal hernias due to high recurrence.
- Emerging data suggest 3D, rigid meshes may not require fixation.
- A knowledge gap exists regarding non-fixation techniques for M3 inguinal hernias.
Purpose of the Study:
- To compare the efficacy of non-fixation versus fixation of meshes in laparoendoscopic repair of M3 inguinal hernias.
- To evaluate recurrence rates, postoperative pain, and surgical complications.
- To assess the noninferiority of non-fixation using 3D meshes.
Main Methods:
- Prospective, multicenter, double-blind, randomized controlled trial (MEsh FIxation STudy).
- 204 patients with M3 inguinal hernias randomized into non-fixation (3D meshes) and fixation (flat meshes with adhesive) groups.
- Primary outcome: 12-month recurrence rate; Secondary outcomes: pain and surgical complications.
Main Results:
- 12-month recurrence rates were 3.1% (non-fixation) and 2.1% (fixation) (P=0.6847).
- No significant differences in postoperative pain or surgical complications between groups.
- Operative times were also comparable between the non-fixation and fixation groups.
Conclusions:
- Non-fixation of 3D meshes is noninferior to fixation of flat meshes for M3 inguinal hernia repair.
- These findings suggest potential revisions to international guidelines to include non-fixation methods.
- Appropriate mesh selection is key for successful non-fixation in hernia repair.
