Single centre observational study to evaluate the safety and efficacy of the Proceed™ Ventral Patch to repair small ventral hernias

Abstract

There is evidence that mesh repair for primary umbilical hernias results in less recurrences and similar wound complication rates compared to tissue repair. In recent years, several mesh devices for the repair of small ventral hernias have been developed, but some reports have been published on serious complications and adverse effects encountered with those mesh devices. The Proceed™ Ventral Patch (PVP™) is a partially absorbable lightweight polypropylene mesh. We introduced PVP™ in our department in April 2009 and collected patient data and outcome in an observational study of 101 consecutive patients until December 2011 (Clinical.Trials.gov: NCT01307696). In addition to the routine control 3weeks postoperative, prospective follow-up included a questionnaire, clinical investigation and ultrasound after 12months. The study included 91 primary (76 umbilical/15 epigastric) and 10 incisional ventral hernias (including 6 trocar hernias). In all patients a PVP™ with a diameter of 6.4cm was used. Wound problems were the most frequent complication (n=18). Follow-up of at least 12months was achieved in 98 patients (97%) and the mean follow-up time was 15.9months. Follow-up by clinical examination diagnosed a recurrence in 11/92 patients (12.0%). Only four patients were aware of their recurrent hernia, the seven others reported no problems in the questionnaire. The additional ultrasound performed did not reveal recurrences that were not already diagnosed by clinical examination. In five patients a reoperation for repair of the recurrence was performed (reoperation rate 5/98=5.1%). Hernia defect size (p=0.032) and type of hernia (p=0.029) were found to be a significant risk factors for development of a recurrent hernia (Fisher's exact test). Hernia size was a significant risk factor both in a univariate (p=0.005) and in a multivariate Cox model (p=0.017). Incisional hernia was of borderline significance in a univariate (p=0.047) and in a multivariate Cox model (p=0.08). Intensive clinical follow-up yields a high percentage (12.0%) of clinically proven, but often asymptomatic recurrences after repair of small ventral hernias with the PVP™. Reoperation rate for recurrence was 5.1%. Hernia defect size is a significant risk factor for recurrence. Therefore, we recommend using the PVP™ only for primary ventral hernias smaller than 2cm. For larger or incisional hernias other techniques allowing the use of larger meshes is advocated.