MEsh FIxation in Laparoendsocopic Repair of Large M3 Inguinal Hernias - Multicenter, Double-blinded, Randomized Controlled Trial – study protocol for a MEFI Trial

Abstract

• Background Guidelines of groin hernia treatment strongly recommends to fixate the mesh in large M3 medial defects during TAPP / TEP procedures. Main purpose of fixation is to decrease recurrence rate which is alarmingly high in case of those defects. In 2022 team consisting of hernia surgeons and scientists from universities of technology conducted an experimental study with the use of 3d groin model to verify the hypothesis that fixation is not necessary in above cases. Experiment showed that rigid and anatomically shaped meshes are able to maintain its position in groin without fixation. Similar conclusions were recently published in Swedish database registry analysis. To confirm above results we decided to conduct multicenter randomized controlled trial.. • Methods Main objective of MEFI Trial is to verify the hypothesis that non-fixation of spatial, standard polypropylene meshes is non-inferior to fixation of flat, polypropylene lightweight meshes in M3 hernias by laparoendoscopic approach. 11 large surgery centers in Poland having proficiency in laparoendoscopic groin hernia repairs were recruited for this study. Recurrence in 12-month follow-up was set as a primary endpoint. Pain sensation (Visual Analog Scale) and incidence of other complications (hematoma, seroma, SSI) were also noted. Based on the statistical analysis, minimal sample size in both arms was established at 83–102. First arm (control) consists of patients undergoing a repair with the use of flat, macroporous mesh with fixation using histoacryl glue. In second arm patients will be operated with the use of anatomically shaped, standard-weight mesh without fixation. Study will be double-blinded (patient/surgeon). After dissection of preperitoneal space, surgeon will open sealed envelope and find out which technique he will have to perform. Follow-up will be performed by Study Secretary (also blinded to method used) via phone call 3 and 12-months after surgery.. • Discussion Based on experimental study and recent registry analysis, we believe that recurrence rate in both groups would be on the same level, giving hernia societies strong argument for amending the guidelines.. Trial registration ClinicalTrials.gov Identifier: NCT05678465 registered on January 10, 2023