PerFix™ plug versus 4DDOME(®) implants for inguinal hernia repair: prospective multicentric randomised controlled trial.

Introduction: Anterior mesh placement is the standard of care for hernia repair. The use of partially absorbable meshes may limit post-operative pain without altering the durability of the repair. We designed a prospective randomised study, which aims to compare the PerFix™ plug to the 4DDOME(®), a partially absorbable mesh.

Materials And Methods: Inguinal hernia patients were prospectively and randomly included in the study. Hernia repair was performed using either the PerFix™ plug (Davol) or the 4DDOME(®) implant (Cousin Biotech). Operative evaluation included type and duration of anaesthesia, characteristics of the incision, post-operative hospital stay and pain evaluated through a visual analogue scale (VAS) at day 1, day 8, month 1, month 6, and year 1. Return to personal or professional activity was evaluated. Quality of life was measured by a SF36 questionnaire at 1, 6, and 12 months' follow-up.

Results: Ninety-five patients were prospectively enrolled and randomised to one type of prosthetic repair. The two groups of patients did not differ in terms of clinical characteristics, type of hernia, and intra-operative course. When comparing PerFix™ plug to 4DDOME(®) groups, the post-operative course was similar: pain (VAS 3.42 (SD 1.83) vs. 3.82 (SD 2.0), p = 0.69); in-hospital stay (2.12 (SD 1.36) vs. 2.25 (SD 1.62), p = 0.67); and return to personal (9.39 days (SD 8.15) vs. 9.48 days (SD 11.68), p = 0.96) and professional activity (25.71 days (SD 17.47) vs. 22.82 days (SD 18.10), p = 0.62). Post-operative pain and discomfort assessed by the SF36 questionnaire at day 8, months 1, 6, and 12 were similar, but significantly lower after 4DDOME(®) repair at 3 months for "pain" (p = 0.021) and at 6 months for "health" criteria (p = 0.028).

Conclusion: This clinical study demonstrated similar short-term results. The 4DDOME(®) was associated with less pain and discomfort after 3 and 6 months. The combination of the dome shape and the double component mesh including an absorbable part meet the conflicting demands of early strength with a long-term low-weight material to minimise shrinkage and fibrosis. This design represents a potential advance in anterior tension-free hernia repair with mesh.