Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Multicenter Study
. 2025 Jun 1;281(6):921-927.
doi: 10.1097/SLA.0000000000006669. Epub 2025 Feb 13.

MEsh FIxation STudy in Laparoendoscopic Repair of M3 Inguinal Hernias: Multicenter, Double-blind, Randomized Controlled Trial-MEFISTO Trial

Mateusz Zamkowski  1   2 , Maciej Ś Mietański  1   3 , Paula Franczak  4 , Dominik Górski  5 , Jacek Grabias  6 , Michał Janik  7 , Aleksander Król  8 , Kryspin Mitura  9 , Olaf Mędraś  10 , Łukasz Nawacki  11 , Michał Romańczuk  9 , Przemysław Rymkiewicz  12 , Sławomir Saluk  12 , Przemysław Sroczyński  7 , Leszek Sułkowski  13 , Dominik Wieczorek  5 , Marcin Włodarczyk  14
Affiliations
Multicenter Study

MEsh FIxation STudy in Laparoendoscopic Repair of M3 Inguinal Hernias: Multicenter, Double-blind, Randomized Controlled Trial-MEFISTO Trial

Mateusz Zamkowski et al. Ann Surg. .

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.

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.

Keywords: TAPP; laparoendoscopic hernia repair; mesh fixation; randomized controlled trial; recurrence rate.

PubMed Disclaimer

Conflict of interest statement

The authors report no conflicts of interest.

References

    1. Kingsnorth A, LeBlanc K. Hernias: inguinal and incisional. Lancet. 2003;362:1561–1571.
    1. Simons MP, Smietanski M, Bonjer HJ, et al. International guidelines for groin hernia management. Hernia. 2018;22:1–165.
    1. Mayer F, Niebuhr H, Lechner M, et al. When is mesh fixation in TAPP-repair of primary inguinal hernia repair necessary? The register-based analysis of 11,230 cases. Surg Endosc. 2016;30:4363–4371.
    1. Stabilini C, van Veenendaal N, Aasvang E, et al. Update of the international HerniaSurge guidelines for groin hernia management. BJS Open. 2023:5 7:zrad080.
    1. Zamkowski M, Tomaszewska A, Lubowiecka I, et al. Is mesh fixation necessary in laparoendoscopic techniques for M3 inguinal defects? An experimental study. Surg Endosc. 2023;37:1781–1788.