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.

Abstract

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 < 0.001), and this low pain level was maintained at 12 months postsurgery (P < 0.001). The mean global Carolina's Comfort Scale® (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.

• Authors: Frederik Berrevoet, Carl Doerhoff, Filip Muysoms, Steven Hopson, Marco Gallinella Muzi, Simon Nienhuijs, Eric Kullman, Tim Tollens, Mark R Schwartz, Karl LeBlanc, Vic Velanovich, Lars Nannestad Jørgensen
• Journal: Medical devices (Auckland, N.Z.) (Med Devices (Auckl)) Vol. 10 Pg. 81-88 ( 2017) ISSN: 1179-1470 [Print] New Zealand
• PMID: 28553149 (Publication Type: Journal Article)