Early safety and effectiveness of new 3‑dimensional lightweight SWING‑Mesh in minimally‑invasive inguinal hernia repair: a multicenter prospective observational study with 3‑month follow‑up.

Abstract

<h4>Introduction</h4>Independent postmarket clinical evidence for newly introduced inguinal meshes remains limited. We conducted a multicenter prospective observational study to assess early safety and effectiveness of fixation-free SWING-Mesh in transabdominal preperitoneal (TAPP) / totally extraperitoneal (TEP) repair.<h4>Aim</h4>We aimed to assess early (3-month) safety and effectiveness of fixation-free SWING-Mesh use in TAPP/TEP repair.<h4>Materials and methods</h4>A prospective cohort study was conducted in 20 Polish centers, of which 1 was excluded after central monitoring. Consecutive adults underwent elective TAPP or TEP repair with the unfixed polypropylene SWING-Mesh. Exclusion criteria comprised emergency surgery, bowel resection, contraindications to laparoendoscopic repair, and large direct M3 hernias. Recurrence, complications, unplanned visits / interventions and pain (as per the Visual Analog Scale [VAS]) at discharge, 7-10 days, 30 days, and 3 months postoperatively were recorded. The unit of analysis was the operated groin (case).<h4>Results</h4>We analyzed 294 cases in a total of 283 patients at a mean (SD) age of 51.9 (15.9) years, 84.4% of which were men. TAPP repair was performed in 86.4%, and TEP procedure in 13.6% of the patients. There were no instances of hernia recurrence by 3 months postsurgery. Pain decreased over time (<i>P</i> <⁠0.001): mean (SD) VAS score of 1.8 (1.4) at discharge, 1 (1.2) at 7-10 days, 0.5 (1.1) at 30 days, and 0.5 (1) at 3 months postoperatively. At 3 months after the procedure, 78.5% of the individuals reported a VAS score of 0, and 3.1%, a score equal to or greater than 4. Complication rates were below 10% at each time point and were mostly minor; 6.9% or fewer patients required an unplanned visit or intervention by 3 months postoperatively.<h4>Conclusions</h4>Fixation-free SWING-Mesh use in TAPP/TEP repair was associated with favorable early outcomes. Twelve-month follow-up will report long-term recurrence and chronic pain.