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Page 6 of 12                                     Ugliono et al. Mini-invasive Surg 2021;5:2  I  http://dx.doi.org/10.20517/2574-1225.2020.93

               In light of the good results achieved with the introduction of prosthetic materials in inguinal and
               ventral repair surgery, the use of meshes has been proposed also in PEH repair. There is a wide array of
               configurations, materials (including synthetic non-absorbable, absorbable, or biologic matrices), and
               methods of fixation of the mesh (anterior, posterior, or circumferential, with staples, tacks, sutures, or glue) [32-36] .

                                                                                                        [37]
               Several studies showed a reduced recurrence rate with the use of synthetic meshes. For instance, Frantzides et al.
               performed in 2002 a randomized controlled trial (RCT) of patients undergoing laparoscopic PEH repair
               with simple (36 patients) vs. reinforced polytetrafluoroethylene (PTFE) cruroplasty (36 patients). The
               recurrence rate, verified with barium contrast studies, was significantly higher in the simple cruroplasty
               group compared with the PTFE group (22% vs. 0%, P < 0.006).

               Disadvantages related to the use of synthetic materials include the risk of mesh adhesion, erosion of the
                                                                                        [38]
               esophageal wall, and extensive fibrosis resulting in the onset of troublesome dysphagia .
               Biological and absorbable meshes have been proposed to overcome the downsides of synthetic meshes.
                               [39]
               Oelschlager et al.  performed a multicenter RCT to test the efficacy of crural reinforcement with a
               biological mesh derived from porcine small intestinal submucosa (51 patients) compared to primary crural
               closure (57 patients). The authors published in 2006 the phase 1 results of the trial, showing a significant
               reduction in radiological PEH recurrences compared to primary repair (9% vs. 24%) at six-month follow-
               up. However, a longer follow-up of the same study showed a high rate of recurrences, with no significant
                                                                                                 [40]
               differences between the two groups (59% in the mesh group vs. 54% in the primary repair group) .

               The short-term results of biological meshes were also confirmed in a systematic review and meta-
               analysis performed by Antoniou et al.  including five studies comparing simple suture vs. biologic mesh
                                                [41]
               cruroplasty. However, no long-term data were available for analysis.

                           [42]
               Watson et al.  performed a multicenter RCT in 2015 with the aim of comparing three methods of
               PEH repair: primary suture (43 patients), absorbable mesh (41 patients), and non-absorbable mesh (42
               patients) cruroplasty. A combined radiological and endoscopic assessment of recurrences was performed
               at 12-month follow-up, and no significant difference was found among the three groups. These results were
                                              [43]
               also confirmed at five-year follow-up .

               Several meta-analyses described a significant reduction in the recurrence rate at medium-term follow-up,
               including a lower risk of surgical revision, with the use of prosthetic materials, but the quality of analyzed
                                                                                                        [46]
               data was poor and therefore the results are of limited level of evidence [44,45] . For instance, Tam et al.
               performed in 2016 a systematic review and meta-analysis of studies assessing the comparison between
               primary repair and the use of synthetic mesh. They reviewed 13 publications including RCTs and
               observational studies. The overall recurrence rate was found to be 24% (91/382) for the suture group
               compared to 13% (46/354) for the mesh group. However, follow-up was significantly shorter, with only half
               of the patients available for follow-up in the mesh group, therefore recurrences could be underestimated.
               The authors concluded that the available evidence is of low quality and high risk of bias and does not allow
               drawing definitive conclusions.

               Furthermore, more recent series comparing primary vs. mesh reinforced cruroplasty have shown similar
                                                                                            [49]
               outcomes in terms of recurrences at long-term follow-up [47,48] . For instance, Koetje et al.  reported the
               comparison between primary repair (127 patients) and mesh reinforced (62 patients) cruroplasty with a
               follow-up of 40 months. The overall rate of radiological recurrence was similar between the two groups
               (25.8% mesh vs. 23.6% no mesh), with similar reoperation and symptomatic recurrence rates.
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