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Abstract
Background
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 fixation systems dedicated for intraperitoneal onlay mesh procedure. The aim of this study was to compare two different mesh/fixation 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 five (20 %) recurrences in the PH group in first 6 months and none in the VS group. We observed a significantly 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 significantly over time (p < 0.0001) and was significantly 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 significantly greater hernia recurrences and postoperative pain compared with the VS system. This confirms the superiority of the elastic mesh concept, which may be a safer and more efficacious option for laparoscopic ventral hernia repairs.