Preliminary Results of a Single-blinded, Prospective Randomized Controlled Trial Compairing Non-fixating Vs. Self-fixating Mesh for Laparoscopic Inguinal Hernia Repair

Brandon Johnson, BA, Michelle Leong, BS, Kristine Kuchta, MS, Eliza Conaty, BS, Michael Ujiki, MD, Woody Denham, MD, Stephen Haggerty, MD, JoAnn Carbray, BS, Nicolas Bonamici, BS, Matt Gitelis, BS, John Linn, MD. NorthShore University HealthSystem

Introduction: Laparoscopic inguinal hernia repair (LIHR) offers reduced postoperative pain and shorter convalescence compared to open repair. Few studies have assessed whether self-fixating mesh used during LIHR has a significant impact on postoperative quality of life (QoL). We hypothesize that use of self-fixating mesh in totally extraperitoneal (TEP) LIHR will result in less pain and improved QoL compared to non-fixating mesh.

Methods: An IRB-approved, single-blinded randomized controlled trial was offered to patients with primary, unilateral inguinal hernias. Patients were randomized to non-fixating mesh (control) and self-fixating mesh. Participants were seen 3 weeks and 1 year after LIHR. The previously validated Surgical Outcomes Measurement System (SOMS) QoL instrument was used to assess pain, fatigue, and physical function preoperatively and at POD 1-7, 3 weeks, and 1 year. Comparisons between patients with self-fixating and non-fixating mesh groups were made using Chi-Square, Wilcoxon Rank-Sum or Independent Samples T-Tests.

Results: 186 patients were enrolled (95 non-fixating vs. 91 self-fixating). Preoperatively, there was no difference in mean age, mean BMI, or median symptom duration between the control and treatment groups (60.1 vs. 57.4 years, p=0.237; 25.6 vs. 26.1, p=0.354; 2.0 vs. 2.0 months, p=0.762). Median operative times (p=0.328, Table 1), and LOS were similar for the groups (p=0.120, Table 1). More patients in the non-fixating group received tacks (31 vs. 16, p=0.018), but the median number of tacks used was similar (5.5 tacks vs. 5.1, p=0.464). There were zero recurrences in either group. Patients receiving non-fixating mesh recorded significantly better (higher) mean SOMS scores for the first 3 days following surgery (Day 1: p=0.005; Day 2: p=0.002; Day 3: p=0.024, Table 1) indicative of less pain. NSAID use was similar between the groups. Narcotic medication use was more common in the self-fixating group, but amount and duration used were similar (45 vs. 35 patients, p=0.022). No differences in pain were seen at 3 weeks postoperatively (pain quality: p=0.495; pain impact: p=0.780, Table 1). For patients completing 1-year follow up (n=55), no differences in QoL were seen for either group.

Conclusion: Patients receiving self-fixating mesh experience more pain in the first 72 hours postoperatively than those receiving non-fixating mesh. Recurrence rates are similarly low for each group. Mesh groups do not differ in pain impact, pain quality, fatigue or physical function at 3 weeks or 1 year postoperatively. Pain related QoL may not be improved with the use of self-fixating mesh in LIHR.