Synthetic Versus Biologic Mesh for Complex Open Ventral Hernia Repair: 3-Year Follow-Up of a Pilot Randomized Controlled Trial.

Background: Biologic mesh is often used in complex hernia repair, but there has been limited clinical evidence to date to support this practice. The aim of this study was to compare clinical and patient-reported outcomes of biologic versus synthetic mesh for complex open ventral hernia repair (OVHR) at 3 years.

Methods: Patients from a single center, randomized, controlled, pilot trial comparing biologic versus synthetic mesh in complex OVHR were followed for 3 years. The primary outcome focused on major complications, namely mesh infections, hernia recurrences, reoperations, and deaths. Secondary outcomes included surgical site infections, surgical site occurrences, and patient-reported outcomes. Outcomes were assessed using frequentist generalized linear models.

Results: A total of 87 patients (44 biologic mesh, 43 synthetic mesh) were randomized, and 61 patients (70%; 28 biologic and 33 synthetic) completed 3-year follow-up. Baseline demographics were similar in both groups. No significant differences were seen in major complications (50% vs 30%, = .123), mesh infection (14% vs 3%, = .144), recurrence (39% vs 24%, = .214), reoperation (14% vs 9%, = .531), or mortality (4% vs 0%, = .459) between the 2 arms. A single death occurred as a result of bacteremia in a patient with hepatocellular carcinoma. Similarly, no significant differences were seen in secondary or patient-reported outcomes. Both groups demonstrated clinically important improvements in quality of life and pain scores at 3 years.

Conclusion: This study failed to find benefits with biologic mesh as opposed to synthetic mesh in complex OVHR at 3 years when comparing both clinical and patient-reported outcomes.