An analysis of results in a single-blinded, prospective randomized controlled trial comparing non-fixating versus self-fixating mesh for laparoscopic inguinal hernia repair

Abstract

BackgroundIt remains unclear whether use of self-fixating mesh during laparoscopic inguinal hernia repair (LIHR) impacts postoperative quality of life (QoL). We hypothesize patients receiving self-fixating mesh during totally extraperitoneal (TEP) LIHR will report less pain and improved QoL compared to those receiving non-fixating mesh.MethodsAn IRB-approved, single-blinded randomized controlled trial was conducted. Patients with primary, unilateral inguinal hernias were randomized to receive either non-fixating (control) or self-fixating mesh. Clinical visits were conducted 3\xa0weeks and 1\xa0year after LIHR. A validated Surgical Outcomes Measurement System (SOMS) instrument was used to assess patients’ QoL preoperatively and postoperatively along with Carolinas Comfort Scale (CCS) at 3 weeks and 1\xa0year after surgery. Comparisons between self-fixating and non-fixating mesh groups were made using Chi-square, Wilcoxon rank-sum or independent samples t tests.ResultsTwo hundred and seventy patients were enrolled (137 non-fixating vs 133 self-fixating). Preoperatively, there was no difference in mean age, BMI, or median hernia duration between groups (57.9 vs 56.6\xa0years, p\u2009=\u20090.550; 26.1 vs 26.8, p\u2009=\u20090.534; 3.0 vs 3.0\xa0months, p\u2009=\u20090.846). Median operative times (34 vs 34\xa0min, p\u2009=\u20090.545) and LOS were similar. More patients in the non-fixating group received tacks (43 vs 19, p\u2009=\u20090.001). Patients receiving non-fixating mesh recorded better mean SOMS scores for the first 3\xa0days following surgery (Day 1: p\u2009=\u20090.005; Day 2: p\u2009=\u20090.002; Day 3: p\u2009=\u20090.024, Table\xa01) indicating less pain. No differences in pain were seen 3\xa0weeks or 1\xa0year postoperatively. There were zero recurrences found during clinical follow-up in either of the groups.ConclusionsPatients receiving self-fixating mesh report worse postoperative pain in the first 2–3\xa0days than those receiving non-fixating mesh. The groups showed no differences across QoL metrics (SOMS and CCS) at 3\xa0weeks or 1\xa0year postoperatively. Self-fixating mesh does not appear to positively impact QoL after TEP LIHR.