Abstract
Abstract Aim A remaining problem after hernia surgery is the occurrence of chronic pain. Up to now, the use of synthetic meshes is the standard procedure, but there is raising evidence that biological meshes could be advantageous concerning occurrence of chronic pain without the disadvantages of a life-long implant. The BIOLAP trial compares synthetic and biological meshes in laparoendoscopic inguinal hernia repair. To test the hypothesis that the use of biological meshes results in significantly less pain postoperatively than the use of synthetic meshes, without an increased recurrence rate, patients with bilateral primary inguinal hernias were included. Patients received biological mesh on one side and synthetic mesh on the other. Materials and Methods In 21 German hernia centres, 982 hernias were treated using TEP or TAPP techniques. In addition to the study endpoints (recurrence rate within 2 years, pain intensity after 6 months), demographic and perioperative data as well as intraoperative and postoperative complications were recorded. Results Recruitment was successfully completed in February 2021. Six month after laparoendoscopic hernia repair there is no significant difference in pain occurrence comparing biological to synthetic mesh implants. Furthermore general demographics of the patients with bilateral primary inguinal hernias are evaluated. Conclusion The study provides data from 982 hernia operations dependent of the mesh material used. According to the study protocol, at the current time pain intensity after 6 months comparing both mesh materials has been evaluated as the first endpoint. Further study endpoints will be evaluated after completion of the two-year follow-up phase.
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