BIOLAP: biological versus synthetic mesh in laparo-endoscopic inguinal hernia repair: study protocol for a randomized, multicenter, self-controlled clinical trial

DiscussionThere is no reasonably sized trial that assesses the use of biological meshes in laparo-endoscopic inguinal hernia repair.Our self-controlled trial design allows a direct comparison of the two meshes with very few confounding factors as well as minimizing the exclusion criteria. As we compare CE-certified medical devices in their designated indication the medical risk is not different compared to routine clinical care. Due to the common nature of bilateral inguinal hernia, a high recruitment rate is achievable. Because guidelines for hernia repair have stressed the need for reliable data on the already frequent use of biological meshes, we can expect our trial to have a direct implication on hernia-repair standards.Trial registrationGerman Clinical Trials Register, ID:DRKS00010178. Registered on 16.June.2016. BIOLAP underwent full external peer review as part of the funding process with the German Research Foundation.
Source: Trials - Category: Research Source Type: clinical trials