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Objective: The objective of this trial was to identify a superior method for umbilical and epigastric hernia repair in terms of complications. Complications such as an extended operation duration, additional use of painkillers, reoperation, infection, seroma, extended wound care, extended hospitalization, and early recurrence were reported according to the Clavien-Dindo grading system., Summary Background Data: Over the years mesh repair is proven the gold standard for umbilical and epigastric hernias. The question remains, which mesh should be used?, Methods: In this randomized controlled, multicenter trial, all patients ≥ 18 years with a single, symptomatic, and primary small umbilical or epigastric hernia qualified for inclusion. Flat preperitoneal polypropylene mesh repair was compared with patch repair (PROCEED Ventral Patch) (PVP)., Results: A total of 352 patients were randomized; 348 patients received the intervention (n = 177 PVP vs n = 171 mesh). One out of 4 suffered from any kind of complication within 2 years postoperative (27.6%). A significant difference in complications was seen, in favor of polypropylene mesh repair (P = 0.044, 22.1% mesh vs 32.5% PVP). Reoperation was performed in 19 PVP operated patients (10.7%) versus 7 patients with polypropylene mesh repair (4.0%, P = 0.021).No significant differences were seen in recurrences (n = 13, 8.4% PVP vs n = 6, 4.1% mesh, P = 0.127)., Conclusions: In small epigastric and small umbilical hernia repair a flat polypropylene mesh repair was associated with a lower complication rate than PVP repair. No differences in recurrence rates were seen. Combining all complications, the preperitoneal positioned flat polypropylene mesh performed better.

Design: This trial is a randomized controlled, patient-blinded, multicentre, superiority trial., Methods: All patients ≥18 years with a single, symptomatic and primary umbilical or epigastric hernia (<2 fingers) qualified for participation in the study. Flat polypropylene mesh repair was compared to patch repair (PROCEED ® Ventral Patch) (PVP). The objective of this trial was to identify a superior method for umbilical and epigastric hernia repair in terms of complication rates., Results: A total of 352 patients were randomized in this trial; 348 patients received the intervention (n = 177 PVP vs. n = 171 mesh). No peri-operative complications occurred. PVP placement was significantly faster compared to mesh placement (30 min, SD 11 vs. 35 min, SD 11) and was scored as an easier procedure. At 1-month follow-up, 76 patients suffered any kind of complication. There was no significant difference in the proportion of complications (24.9% for PVP and 18.7% for mesh, p = 0.195). A significant difference was seen in re-operation rate within 1 month, significantly less early re-operations in the mesh group (0.0 vs. 2.8%, p = 0.027). After 1-year follow-up, no significant differences are seen in recurrence rates (n = 13, 7.8% PVP vs. n = 5, 3.3% mesh, p = 0.08)., Conclusions: Both mesh and PVP had a comparable amount of reported complications. There was a significantly higher incidence of early re-operations due to early complications in the PVP group. No differences were seen in infection rates and the need for antibiotic treatment. No significant difference was seen in the recurrence rates., Registration: This trial was registered in the Dutch Trail Registry (NTR) NTR2514NL33995.060.10. [12].