MEsh FIxation in Laparoendsocopic Repair of Large M3 inguinal hernias: multicenter, double-blinded, randomized controlled trial—study protocol for a MEFI Trial

Trials

Study Protocol

Mateusz Zamkowski¹  Maciej Śmietański² 

[1] General Surgery and Hernia Centre, Swissmed Hospital, Gdańsk, Poland;General Surgery and Hernia Centre, Swissmed Hospital, Gdańsk, Poland;2nd Department of Radiology, Medical University of Gdańsk, Gdańsk, Poland;

关键词: Hernia;    TAPP;    TEP;    Laparoendoscopy;    Miniinvasive;    Mesh;    Medial hernia;    Groin hernia;    Inguinal hernia;   

DOI  :  10.1186/s13063-023-07601-9

 received in 2023-03-27, accepted in 2023-08-21,  发布年份 2023

来源: Springer

【 摘 要 】

BackgroundInternational guidelines of groin hernia treatment strongly recommend to fixate the mesh in large M3 medial defects during TAPP/TEP procedures. The main purpose of fixation is to decrease the recurrence rate which is alarmingly high in case of those defects. In 2022, a 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 the groin without fixation. Similar conclusions were recently published in Swedish database registry analysis. To confirm above results, we decided to conduct a multicenter randomized controlled trial.MethodsMain 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. Eleven 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. The first arm (control) consists of patients undergoing a repair with the use of a flat, macroporous mesh with fixation using histoacryl glue. In the 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 the dissection of preperitoneal space, surgeon will open a sealed envelope and find out which technique he will have to perform. Follow-up will be performed by Study Secretary (also blinded to the method used) via phone call 3 and 12 months after surgery.DiscussionBased on experimental study and recent registry analysis, we believe that the recurrence rate in both groups would be on the same level, giving hernia societies a strong argument for amending the guidelines.Trial registrationClinicalTrials.gov NCT05678465. Registered on 10 January 2023.

【 授权许可】

CC BY   
© BioMed Central Ltd., part of Springer Nature 2023

【 图 表 】

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