J E H Ponten1, B J M Leenders2,3, W K G Leclercq2, T Lettinga4, J Heemskerk5, J L M Konsten3, P S S Castelijns6, S W Nienhuijs6. 1. Departement of Surgery, Catharina Ziekenhuis Eindhoven, Michelangelolaan 2, 5623 EJ, Eindhoven, The Netherlands. jeroen.ponten@catharinaziekenhuis.nl. 2. Departement of Surgery, Maxima Medisch Centrum, De Run 4600, 5504 DB, Veldhoven, The Netherlands. 3. Departement of Surgery, VieCuri Medisch Centrum, Tegelseweg 210, 5912 BL, Venlo, The Netherlands. 4. Departement of Surgery, St. Jans Gasthuis Weert, Vogelsbleek 5, 6001 BE, Weert, The Netherlands. 5. Departement of Surgery, Laurentius Ziekenhuis Roermond, Monseigneur Driessenstraat 6, 6043 CV, Roermond, The Netherlands. 6. Departement of Surgery, Catharina Ziekenhuis Eindhoven, Michelangelolaan 2, 5623 EJ, Eindhoven, The Netherlands.
Abstract
DESIGN: This trial is a randomized controlled, patient-blinded, multicentre, superiority trial. METHODS:All patients ≥18years 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].
RCT Entities:
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].
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