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
Received 19 January 2017
Accepted for publication 8 March 2017
Published 12 May 2017 Volume 2017:10 Pages 81—88
Checked for plagiarism Yes
Review by Single anonymous peer review
Peer reviewer comments 2
Editor who approved publication: Dr Scott Fraser
Frederik Berrevoet,1 Carl Doerhoff,2 Filip Muysoms,3 Steven Hopson,4 Marco Gallinella Muzi,5 Simon Nienhuijs,6 Eric Kullman,7 Tim Tollens,8 Mark R Schwartz,9 Karl LeBlanc,10 Vic Velanovich,11 Lars Nannestad Jørgensen12
1Department of General and Hepatopancreaticobiliary Surgery, Ghent University Hospital, Ghent, Belgium; 2General Surgery, Surgicare of Missouri, Jefferson City, MO, USA; 3Department of Surgery, AZ Maria Middelares Ghent, Ghent, Belgium; 4Bon Secours Hernia Center, Mary Immaculate Hospital, Newport News, VA, USA; 5University Hospital Tor Vergata, Rome, Italy; 6Catharina Hospital, Eindhoven, the Netherlands; 7Medicinskt Centrum Linköping, Linköping, Sweden; 8Imelda Hospital-General Surgery Imelda Hospital, Bonheiden, Belgium; 9Monmouth Medical Center, Long Branch, NJ, 10Our Lady of Lakes Regional Medical Center, Baton Rouge, LA, 11Tampa General Hospital, University of South Florida, Tampa, FL, USA; 12Bispebjerg Hospital, University of Copenhagen, Copenhagen, Denmark
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.
Keywords: intraperitoneal mesh, epigastric hernia, umbilical hernia, pain
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