General Surgery and Hernia Centre, Swissmed Hospital, Gdańsk, Poland.
2nd Department of Radiology, Medical University of Gdańsk, Gdańsk, Poland.
Trials. 2023 Sep 5;24(1):572. doi: 10.1186/s13063-023-07601-9.
International 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.
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. 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.
Based 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.
ClinicalTrials.gov NCT05678465. Registered on 10 January 2023.
国际腹股沟疝治疗指南强烈建议在 TAPP/TEP 手术中固定大型 M3 内侧缺损处的网片。固定的主要目的是降低复发率，而在这些缺损的情况下，复发率非常高。2022 年，由疝外科医生和来自技术大学的科学家组成的团队进行了一项使用 3D 腹股沟模型的实验研究，以验证固定在这种情况下不是必需的假设。实验表明，刚性和解剖形状的网片能够在没有固定的情况下保持其在腹股沟的位置。最近在瑞典数据库登记分析中也得出了类似的结论。为了证实上述结果，我们决定进行一项多中心随机对照试验。
MEFI 试验的主要目的是验证以下假设：在腹腔镜腹股沟疝修补术中，非固定空间标准聚丙烯网片与固定平面轻量聚丙烯网片相比，在 M3 疝中不劣于固定。波兰的 11 个大型手术中心具有腹腔镜腹股沟疝修复方面的专业知识，被招募参加这项研究。12 个月随访时的复发率被设定为主要终点。还记录了疼痛感觉（视觉模拟量表）和其他并发症（血肿、血清肿、SSI）的发生率。根据统计分析，两个组的最小样本量分别确定为 83-102。第一个组（对照组）由接受使用平面、大孔网片修复的患者组成，使用组织胶固定。在第二个组中，患者将使用解剖形状、标准重量的网片进行手术，不进行固定。该研究将采用双盲（患者/外科医生）方法。在腹膜前间隙解剖后，外科医生将打开一个密封的信封，了解他将不得不执行哪种技术。研究秘书将通过电话（3 个月和 12 个月）在术后对患者进行随访。
基于实验研究和最近的登记分析，我们相信两组的复发率将处于同一水平，这为疝学会修改指南提供了有力的依据。
ClinicalTrials.gov NCT05678465。于 2023 年 1 月 10 日注册。
