Abstract
BackgroundThis study assessed clinical outcomes, including safety and recurrence, from the two-year follow-up of patients who underwent open ventral primary hernia repair with the use of the Parietex™ Composite Ventral Patch (PCO-VP).MethodsA prospective single-arm, multicenter study of 126 patients undergoing open ventral hernia repair for umbilical and epigastric hernias with the PCO-VP was performed.ResultsOne hundred twenty-six subjects (110 with umbilical hernia and 16 with epigastric hernia) with a mean hernia diameter of 1.8 cm (0.4–4.0) were treated with PCO-VP. One hundred subjects completed the two-year study. Cumulative hernia recurrence was 3.0% (3/101; 95%CI: 0.0–6.3%) within 24 months. Median Numeric Rating Scale pain scores improved from 2 [0–10] at baseline to 0 [0–3] at 1 month (P < 0.001) and remained low at 24 months 0 [0–6] (P < 0.001). 99% (102/103) of the patients were satisfied with their repair at 24 months postoperative.ConclusionsThe use of PCO-VP to repair primary umbilical and epigastric defects yielded a low recurrence rate, low postoperative and chronic pain, and high satisfaction ratings, confirming that PCO-VP is effective for small ventral hernia repair in the two-year term after implantation.Trial registrationThe study was registered publically at clinicaltrials.gov (NCT01848184 registered May 7, 2013).
Highlights
This study assessed clinical outcomes, including safety and recurrence, from the two-year follow-up of patients who underwent open ventral primary hernia repair with the use of the ParietexTM Composite Ventral Patch (PCO-VP)
A total of 110 (87.3%) patients were assessed at 12 months and 100 (79.4%) patients were assessed at 24 months for hernia recurrence and completed the two-year clinical assessment for the primary endpoint
Most patients who exited the study before 24 months were lost to follow-up (9.5%, n = 12/126), withdrew voluntarily (6.3%, n = 8/126), were unable or unwilling to participate in follow-up visits (2.4%, n = 3/126), exited due to Adverse event (AE) (1.6%, n = 2/126), or death (0.8%, n = 1/126) that was not procedure or device related
Summary
This study assessed clinical outcomes, including safety and recurrence, from the two-year follow-up of patients who underwent open ventral primary hernia repair with the use of the ParietexTM Composite Ventral Patch (PCO-VP). The first by Arroyo et al showed an 11% versus 1% recurrence rate after primary suture and mesh repair [1]. By Polat et al compared 3 different techniques in umbilical hernia repairs (Prolene Hernia System, Mayo repair, and onlay repair with mesh) and demonstrated recurrence rates of 0, 11, and 0%, respectively [2]. According to Arroyo et al and retrospectively shown by Sanjay et al, the conclusion could be further studies on the two most frequently used mesh devices revealed several issues influencing clinical outcomes. Cases of serious complications due to severe adhesion formation as well as higher recurrence rates compared to traditional retromuscular mesh placement have been reported [4,5,6]. The currently available devices for repair of small ventral hernias consist of polypropylene (PP) in combination with well known anti-adhesive barriers, as ePTFE, sepramesh technology or oxidized cellulose
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