Prolene Hernia System, Lichtenstein mesh and plug-and-patch for primary inguinal hernia repair: 3-year outcome of a prospective randomised controlled trial. The BOOP study: bi-layer and connector, on-lay, and on-lay with plug for inguinal hernia repair.

Background: Dissection requirements differ between various methods for inguinal hernia repair, which may affect operation times, pain response and possibly recovery time. The objectives of this study were to establish if any differences concerning these aspects could be detected following three principally different techniques for primary inguinal hernia repair.

Methods: A total of 472 men between 30 and 75 years of age with primary inguinal hernias were included in a prospective controlled study and randomised to Lichtenstein mesh (L), PerFix Plug (P) or the Prolene Hernia System (PHS) procedure. All patients were seen and data were collected after 2 weeks, 3 months, 1 year and 3 years.

Results: The follow-up rates were 100, 99.8, 98.7 and 95.3%, respectively. The mean operation time was shorter for P (35.5 min, P < 0.001) and PHS (37.4 min, P < 0.02) versus L (40.4 min). More than 85% of the procedures were performed under local anaesthesia. There were no statistically significant differences between the groups concerning early or late complications, return to full functional ability, early pain response, analgesic consumption or the studied late-outcome parameters after 3 years of observation. Seven (1.5%) evenly distributed recurrences were registered.

Conclusion: All of the techniques are suitable for operation under local anaesthesia. The PHS and P techniques can be performed with shorter operation times than the L method. Early and late outcomes are, however, comparable, with no significant differences concerning complication rates, return to full functional status and/or pain response.