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.