Open ventral hernia repair with a composite ventral patch - final results of a multicenter prospective study

F Berrevoet, C Doerhoff, F Muysoms, S Hopson, M G Muzi, S Nienhuijs, E Kullman, T Tollens, M Schwartz, K Leblanc, V Velanovich, L N Jørgensen, F Berrevoet, C Doerhoff, F Muysoms, S Hopson, M G Muzi, S Nienhuijs, E Kullman, T Tollens, M Schwartz, K Leblanc, V Velanovich, L N Jørgensen

Abstract

Background: 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 Parietex™ Composite Ventral Patch (PCO-VP).

Methods: A prospective single-arm, multicenter study of 126 patients undergoing open ventral hernia repair for umbilical and epigastric hernias with the PCO-VP was performed.

Results: One 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.

Conclusions: The 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 registration: The study was registered publically at clinicaltrials.gov ( NCT01848184 registered May 7, 2013).

Keywords: Epigastric hernia; Intraperitoneal mesh; Parietex™ composite ventral patch; Surgical mesh; Umbilical hernia; Ventral hernia.

Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Numerical Rating Scale Pain Assessment. Patient pain levels by post-operative visit. Whiskers are drawn from quartiles (Q1 – Median – Q3 to the extreme values of the group) * indicates P < 0.05 relative to baseline
Fig. 2
Fig. 2
Patient satisfaction by percentage at visits 1-, 6-, 12- and 24-months postoperative

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