An analysis of results in a single-blinded, prospective randomized controlled trial comparing non-fixating versus self-fixating mesh for laparoscopic inguinal hernia repair
It 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.
An 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 weeks and 1 year 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 year after surgery. Comparisons between self-fixating and non-fixating mesh groups were made using Chi-square, Wilcoxon rank-sum or independent samples t tests.
Two 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 years, p = 0.550; 26.1 vs 26.8, p = 0.534; 3.0 vs 3.0 months, p = 0.846). Median operative times (34 vs 34 min, p = 0.545) and LOS were similar. More patients in the non-fixating group received tacks (43 vs 19, p = 0.001). Patients receiving non-fixating mesh recorded better 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) indicating less pain. No differences in pain were seen 3 weeks or 1 year postoperatively. There were zero recurrences found during clinical follow-up in either of the groups.
Patients receiving self-fixating mesh report worse postoperative pain in the first 2–3 days than those receiving non-fixating mesh. The groups showed no differences across QoL metrics (SOMS and CCS) at 3 weeks or 1 year postoperatively. Self-fixating mesh does not appear to positively impact QoL after TEP LIHR.
KeywordsSelf-fixating mesh Inguinal hernia Quality of life Laparoscopy Chronic pain
An industry sponsored research grant from Medtronic was received for this study.
Compliance with ethical standards
Dr. Michael Ujiki declares honoraria received from Medtronic for speaking engagements unrelated to any commercial products or services utilized in the current study. Dr. John Linn declares industry sponsored research grants from Medtronic and CR Bard for the current study. He also declares personal fees from Medtronic for speaking and teaching unrelated to any commercial products or services utilized in the current study. Merritt Denham, Brandon Johnson, Michelle Leong, Kristine Kuchta, Eliza Conaty, Matt Gitelis, and Drs. Stephen Haggerty, Zeeshan Butt, and Woody Denham have no conflicts of interest or financial ties to disclose.
- 7.Kingsnorth A, Gingell-Littlejohn M, Nienhuijs S et al (2012) Randomized controlled multicenter international clinical trial of self-gripping Parietex ProGrip polyester mesh versus lightweight polypropylene mesh in open inguinal hernia repair: interim results at 3 months. Hernia 16:287–294CrossRefGoogle Scholar
- 19.Patel LY, Lapin B, Gitelis ME, Brown C, Linn JG, Haggerty S, Denham W, Butt Z, Barrera E, Joehl R, Carbray J, Hall T, Ujiki MB (2016) Long-term patterns and predictors of pain following laparoscopic inguinal hernia repair: a patient-centered analysis. Surg Endosc. https://doi.org/10.1007/s00464-016-5207-0 CrossRefPubMedPubMedCentralGoogle Scholar