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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

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Berrevoet, Frederik ; Doerhoff, Carl ; Muysoms, Filip ; Hopson, Steven ; Muzi, Marco Gallinella ; Nienhuijs, Simon ; Kullman, Eric ; Tollens, Tim ; Schwartz, Mark R ; LeBlanc, Karl ; Velanovich, Vic ; Jørgensen, Lars Nannestad. / 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. I: Medical devices (Auckland, N.Z.). 2017 ; Bind 10. s. 81-88.

Bibtex

@article{4a47083eff8b465e8c39669dea50bdcd,
title = "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({\circledR}) (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 = "Journal Article",
author = "Frederik Berrevoet and Carl Doerhoff and Filip Muysoms and Steven Hopson and Muzi, {Marco Gallinella} and Simon Nienhuijs and Eric Kullman and Tim Tollens and Schwartz, {Mark R} and Karl LeBlanc and Vic Velanovich and J{\o}rgensen, {Lars Nannestad}",
year = "2017",
doi = "10.2147/MDER.S132755",
language = "English",
volume = "10",
pages = "81--88",
journal = "Medical Devices: Evidence and Research",
issn = "1179-1470",
publisher = "Dove Medical Press Ltd.",

}

RIS

TY - JOUR

T1 - A multicenter prospective study of patients undergoing open ventral hernia repair with intraperitoneal positioning using the monofilament polyester composite ventral patch

T2 - interim results of the PANACEA study

AU - Berrevoet, Frederik

AU - Doerhoff, Carl

AU - Muysoms, Filip

AU - Hopson, Steven

AU - Muzi, Marco Gallinella

AU - Nienhuijs, Simon

AU - Kullman, Eric

AU - Tollens, Tim

AU - Schwartz, Mark R

AU - LeBlanc, Karl

AU - Velanovich, Vic

AU - Jørgensen, Lars Nannestad

PY - 2017

Y1 - 2017

N2 - 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.

AB - 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.

KW - Journal Article

U2 - 10.2147/MDER.S132755

DO - 10.2147/MDER.S132755

M3 - Journal article

VL - 10

SP - 81

EP - 88

JO - Medical Devices: Evidence and Research

JF - Medical Devices: Evidence and Research

SN - 1179-1470

ER -

ID: 50626711