Biological vs Synthetic Mesh in Laparoendoscopic Inguinal Hernia Repair: The BIOLAP Randomized Clinical Trial.

Abstract

<h4>Importance</h4>Chronic postoperative pain and recurrence are relevant complications after inguinal hernia repair. Biological meshes have been proposed as a resorbable alternative to synthetic implants that may reduce postoperative pain.<h4>Objective</h4>To compare postoperative pain and recurrence rates between biological and synthetic meshes in laparoendoscopic inguinal hernia repair using a self-controlled design.<h4>Design, setting, and participants</h4>The Biological vs Synthetic Mesh in Laparoendoscopic Inguinal Hernia Repair (BIOLAP) trial was a multicenter, randomized, self-controlled clinical trial conducted between August 2017 and February 2021 across 21 certified German hernia centers. A total of 491 adult patients with primary bilateral inguinal hernias underwent laparoendoscopic repair using 1 biological mesh and 1 synthetic mesh. Data analysis was performed from July 2023 to June 2024.<h4>Intervention</h4>Patients were randomized to receive a biological or synthetic mesh on the right side; the contralateral side received the alternate material. All patients underwent standardized laparoendoscopic repair (transabdominal preperitoneal plasty or total extraperitoneal plasty), and both patients and assessors were blinded to mesh assignment.<h4>Main outcomes and measures</h4>The coprimary outcomes were pain intensity at 6 months (measured using the visual analog scale) and hernia recurrence at 2 years. Secondary outcomes included seroma, hematoma, surgical site infection, and patient satisfaction.<h4>Results</h4>Among 491 patients (mean [SD] age, 58.5 [14.1] years; 457 [93.1%] male), there was no significant difference in pain at 6 months between biological and synthetic meshes (mean [SD] visual analog scale score at rest, 0.3 [0.9] for both; P = .76). However, the 2-year recurrence rate was significantly higher for biological meshes (53 recurrences [11.2%]) compared with synthetic meshes (12 recurrences [2.5%]) (P < .001). Seroma rates were also significantly higher with biological meshes than with synthetic meshes (164 patients [33.4%] vs 106 patients [21.6%], respectively; P < .001).<h4>Conclusions and relevance</h4>Biological meshes did not reduce postoperative pain but were associated with significantly higher recurrence and seroma rates compared with synthetic meshes. These findings do not support the routine use of biological meshes in laparoendoscopic inguinal hernia repair.<h4>Trial registration</h4>German Clinical Trials Register Identifier: DRKS00010178.