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Web End = Surg Endosc (2016) 30:11881197 DOI 10.1007/s00464-015-4329-0
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Web End = Comparison of two different concepts of mesh and xation technique in laparoscopic ventral hernia repair: a randomized controlled trial
Maciej Pawlak1,2 Ralf-Dieter Hilgers3 Kamil Bury2 Andrzej Lehmann1
Radosaw Owczuk4 Maciejmietaski5
Received: 14 March 2015 / Accepted: 9 June 2015 / Published online: 3 July 2015 Springer Science+Business Media New York 2015
AbstractBackground Patients need to improve outcomes and to reduce the number of complications triggers the development of new materials and surgery concepts. Currently, there are many implants and xation systems dedicated for intraperitoneal onlay mesh procedure. The aim of this study was to compare two different mesh/xation system concepts (PH: Physiomesh/Securestrap and VS: Ventralight ST/SorbaFix) for laparoscopic ventral hernia repair with respect to pain.
Methods A single-center, prospective, randomized study was designed to include 50 patients per group with a planned interim analysis for safety after 25 patients. The endpoints were pain occurrences and intensity, which was measured with the visual analogue scale 7 days, 30 days, 3 months and 6 months after surgery. The safety parameters included the number of recurrences and postoperative complications.
Results During the interim analysis, the study was stopped due to safety reasons. We observed ve (20 %) recurrences in the PH group in rst 6 months and none in the VS group. We observed a signicantly higher pain rate in the PH group after 3 months (p \ 0.0001) and no difference after 7 days (p = 0. 7019). The pain intensity decreased signicantly over time (p \ 0.0001) and was signicantly higher in the PH group (p \ 0.0001).
Conclusions Although this clinical trial was terminated prior to the preplanned recruitment goal, the obtained results from the enrolled patients indicate that the PH system associated with signicantly greater hernia recurrences and postoperative pain compared with the VS system. This conrms the superiority of the elastic mesh concept, which may be a safer and more efcacious option for laparoscopic ventral hernia repairs.
Keywords Laparoscopic abdominal wall hernia repair
Ventral hernia Incisional...