PURPOSE:This study assessed the recurrence rate and other safety and efficacy parameters following ventral hernia repair with a polyester composite prosthesis (Parietex™ Composite Ventral Patch [PCO-VP]).PATIENTS AND METHODS:A single-arm, multicenter prospective study of 126 patients undergoing open ventral hernia repair with the PCO-VP was performed. Patient outcomes were assessed at discharge and at 10 days, 1, 6, 12, and 24 months postoperative.RESULTS:All patients had hernioplasty for umbilical (n = 110, 87.3%) or epigastric hernia (n = 16, 12.7%). Mean hernia diameter was 1.8 ± 0.8 cm. Mean operative time was 36.2 ±15.6 minutes, with a mean mesh positioning time of 8.1 ± 3.4 minutes. Surgeons reported satisfaction with mesh ease of use in 95% of surgeries. The cumulative hernia recurrence rate at 1 year was 2.8% (3/106). Numeric Rating Scale (NRS) pain scores showed improvement from 2.1 ± 2.0 at preoperative baseline to 0.5 ± 0.7 at 1 month postoperative (P < 0.001), and this low pain level was maintained at 12 months postsurgery (P < 0.001). The mean global Carolina's Comfort Scale® (CCS) score improved postoperatively from 3.8 ± 6.2 at 1 month to 1.6 ± 3.5 at 6 months (P < 0.001). One patient was unsatisfied with the procedure.CONCLUSION:This 1-year interim analysis using PCO-VP for primary umbilical and epigastric defects shows promising results in terms of mesh ease of use, postoperative pain, and patient satisfaction. Recurrence rate is low, but, as laparoscopic evaluation shows a need for patch repositioning in some cases, an accurate surgical technique remains of utmost importance.

BACKGROUND Surgeons utilise various mesh fixation methods during hernia repair which may include tacks/straps and/or sutures. One of these tack/strap choices, is an absorbable fixation device, Securestrap® (ETHICON, Somerville, NJ), consisting of polydioxanone and L (-)-lactide/glycolide copolymer. The 6 month clinical results and patient outcomes with Securestrap® fixation are reported. METHOD The International Hernia Mesh Registry, prospective multi-centre registry, designed to collect patient reported, longitudinal data on hernia mesh products and fixation methods. Patients completed the Carolinas Comfort Scale™ (CCS). Symptomatic patient defined as responding >1 to any CCS™ question. P-values obtained by McNemar test and Kaplan Meier methods used to estimate the recurrence rate up to 183 days. RESULTS Patients enrolled at 17 centres with data on 101 of the 216 patients who had reached the 6 month time point. Demographics were: mean age 53.0 (13.2 SD); mean BMI 33.0 (7.7 SD) kg/m²; females (51.4%); nonsmokers (46.4%). Majority of hernias were incisional/ventral (57.9%) and most were laparoscopic (98.1%). Mesh fixation was with tacks/straps (50.5%) or tacks/straps and sutures (49.5%). Symptomatic CCS™ pains scores improved from baseline to 1 month and improved significantly from 1 month to 6-months (69.1% to 60.6%, p=0.0858; 60.6% to 22.8%, p=0.0002), respectively. Similar results were observed with symptomatic CCS™ movement limitations. The recurrence rate was 1.8% (0.6%-5.4%); 2 medically confirmed; 1 had not yet been assessed. CONCLUSION Mesh fixation using absorbable tacks/straps with or without additional sutures results showed statistical significant improvement in patient reported outcomes at 6 months as compared to baseline. Follow-up continues.