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AN ANALYSIS OF RESULTS IN A SINGLE-BLINDED, PROSPECTIVE RANDOMIZED CONTROLLED TRIAL COMPARING NON-FIXATING VS. SELF-FIXATING MESH FOR LAPAROSCOPIC INGUINAL HERNIA REPAIR

Merritt Denham, BS, Brandon Johnson, BA, Michelle Leong, BA, Kristine Kuchta, MS, Eliza Conaty, BS, Michael Ujiki, MD, Woody Denham, MD, Stephen Haggerty, MD, JoAnn Carbray, BS, Mat 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, however it remains unclear whether the use of self-fixating mesh during LIHR might notably impact postoperative quality of life (QoL). We hypothesize that patients receiving self-fixating mesh during totally extraperitoneal (TEP) LIHR will report less pain and improved QoL compared to those receiving 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 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’ quality of life (QoL) preoperatively, and was also collected postoperatively along with the 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.

Results: The study enrolled 270 patients (137 non-fixating vs. 133 self-fixating). Preoperatively, there was no differences in mean age, BMI, or median hernia duration between the control and treatment 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 minutes, p=0.545), and LOS were similar for the groups. More patients in the non-fixating group received tacks (43 vs. 19, p=0.001), but the median number of tacks used was similar (5.4 tacks vs. 5.1, p=0.468). 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. Narcotic medication and NSAID use were similar between the groups.. No differences in pain were seen at 3 weeks or 1 year postoperatively, and CCS scores also did not differ between the groups at either time point (Table 1). There were zero recurrences found during clinical follow up in either of the groups.

Conclusion: Patients receiving self-fixating mesh report worse postoperative pain in the first 2-3 days after surgery than those receiving non-fixating mesh. Recurrence rates are similarly low for each group. The mesh groups showed no differences across a wide array of QoL metrics (SOMS and CCS) either at 3 weeks or 1 year postoperatively. Self-fixating mesh does not appear to positively impact pain-related QoL after TEP LIHR.

 


Presented at the SAGES 2017 Annual Meeting in Houston, TX.

Abstract ID: 88187

Program Number: S005

Presentation Session: Hernia Session

Presentation Type: Podium

35

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