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- Title
An analysis of results in a single-blinded, prospective randomized controlled trial comparing non-fixating versus self-fixating mesh for laparoscopic inguinal hernia repair.
- Authors
Denham, Merritt; Johnson, Brandon; Leong, Michelle; Kuchta, Kristine; Conaty, Eliza; Ujiki, Michael B.; Denham, Woody; Haggerty, Stephen P.; Butt, Zeeshan; Carbray, JoAnn; Gitelis, Matt; Linn, John G.
- Abstract
<bold>Background: </bold>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.<bold>Methods: </bold>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.<bold>Results: </bold>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.<bold>Conclusions: </bold>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.
- Subjects
SURGICAL robots; INGUINAL hernia; RANDOMIZED controlled trials; POSTOPERATIVE pain
- Publication
Surgical Endoscopy & Other Interventional Techniques, 2019, Vol 33, Issue 8, p2670
- ISSN
1866-6817
- Publication type
journal article
- DOI
10.1007/s00464-018-6555-8