A multicenter prospective study of patients undergoing open ventral hernia repair with intraperitoneal positioning using the
monofilament polyester composite ventral patch: interim results of the PANACEA study

摘要

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 ? (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.