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 (TM) 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 1.8cm (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 24months. 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 24months 0 [0-6] (P<0.001). 99% (102/103) of the patients were satisfied with their repair at 24months 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).
Berrevoet, F., Doerhoff, C., Muysoms, F., Hopson, S., Gallinella Muzi, M., Nienhuijs, S., et al. (2019). Open ventral hernia repair with a composite ventral patch - Final results of a multicenter prospective study. BMC SURGERY, 19(1), 93 [10.1186/s12893-019-0555-z].
Open ventral hernia repair with a composite ventral patch - Final results of a multicenter prospective study
Gallinella Muzi M.;
2019-01-01
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 (TM) 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 1.8cm (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 24months. 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 24months 0 [0-6] (P<0.001). 99% (102/103) of the patients were satisfied with their repair at 24months 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).I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
