OC-090 MESH FIXATION IN LAPAROENDSOCOPIC REPAIR OF LARGE M3 INGUINAL HERNIAS – MULTICENTER, DOUBLE-BLINDED, RANDOMIZED TRIAL -> MEFI TRIAL

Abstract

Abstract Introduction Guidelines of groin hernia treatment strongly recommends to fixate the mesh in large M3 medial defects during TAPP / TEP. 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. To confirm experimental results we decided to conduct RCT. Study Hypothesis Non-fixation of spatial, standard polypropylene meshes is non-inferior as compared to fixation of flat, polypropylene lightweight meshes in m3 hernias. Materials and Methods 11 large surgery centres in poland were recruited for this study. recurrence in 12-month follow-up was set as a primary endpoint. pain sensation (vas scale) was made secondary endpoint. minimal sample sizes were established 82–103 in each arm. first arm (control): patients repaired with the use of flat, macroporous mesh with fixation. second arm (experimental): patients repaired with the use of anatomically shaped, standard mesh without fixation. after dissection of preperitoneal space, surgeon will find out the technique he will have to perform. patients won't be aware of the method. pain and reccurence will be measured during the hospital stay and then up to 12-months after surgery. Predicted Outcomes Based on experimental study and own experience, we believe that recurrence rate in both groups (control and experimental) would be on the same level givingba strong argument for amending the guidelines.