Self-fixating (sutureless) mesh versus sutured polypropylene mesh in open Lichtenstein repair: a participant-blinded randomized trial.

BACKGROUND: Open Lichtenstein inguinal hernia repair has been associated with chronic postoperative inguinal pain (CPIP), which remains a problematic outcome. Self-fixating (sutureless) mesh may lessen the tissue trauma from fixation sutures and improve postoperative pain-related outcomes. METHODS: Two hundred adult male patients scheduled for elective open Lichtenstein repairs for primary inguinal hernia were enrolled in this single-center parallel-group randomized controlled trial. Participants were randomized to either Group A (self-fixating/sutureless mesh, n = 100) or Group B (sutured polypropylene mesh, n = 100) in a 1:1 ratio. Participants were followed for 6 months. “Pain was measured on postoperative day 1 and at 2 weeks, 2 months, 4 months, and 6 months using a 0–100 visual analog scale (VAS). CPIP was assessed at 4 and 6 months. Secondary outcomes included the SF-36 total score, operative time, length of stay, time to return to work, complications, and mesh-related patient-reported numbness and sensation. Between-group comparisons were conducted at each time point with Holm adjustment for multiple comparisons for each outcome. RESULTS: Group A had lower VAS pain scores than Group B at all time intervals (Holm-adjusted p < 0.001). For example, mean VAS scores were 16.8 ± 4.1 vs 31.5 ± 8.5 on day 1 (mean difference − 14.7; 95% CI − 16.6 to − 12.8), and at 6 months they were 3.8 ± 0.9 vs 12.6 ± 2.8 (mean difference − 8.8; 95% CI − 9.38 to − 8.22). Rescue analgesics during hospitalization were less in Group A (mean difference − 1.40 doses; 95% CI − 1.65 to − 1.15; p < 0.001). Group A had less CPIP at 4 months (2% vs 20%; RR 0.10, 95% CI 0.02 − 0.42; Holm-adjusted p < 0.001) and at 6 months (1% vs 10%; RR 0.10, 95% CI 0.01 − 0.77; Holm-adjusted p = 0.010). SF-36 scores also improved in both groups, but the Holm-adjusted scores did not remain significant. Group A had shorter operative time (mean difference − 11.2 min; 95% CI − 14.1 to − 8.3; p < 0.001), whereas the remaining outcomes, including length of hospital stay, time to return to work, and postoperative complication rates, were similar between the groups. CONCLUSIONS: In adult males who underwent open Lichtenstein repair, self-fixing (sutureless) mesh was associated with lower postoperative pain and a lower incidence of CPIP at 6 months, shorter operative time, and no increase in early complications. These findings warrant additional research, including longer follow-up and multicenter studies.