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Differential recurrence after laparoscopic incisional hernia repair: importance of a nationwide registry-based mesh surveillance

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@article{36264709f3cb42399c410cac5dbc00f3,
title = "Differential recurrence after laparoscopic incisional hernia repair: importance of a nationwide registry-based mesh surveillance",
abstract = "Background: Identification of suboptimal mesh products is essential to improve the outcome after hernia surgery. This study investigated whether a national clinical database combined with administrative registries may serve as a tool for postmarketing evaluation of mesh products for hernia surgery. Methods: This was a propensity score-matched case–control cohort study comparing outcomes in patients undergoing laparoscopic incisional hernia repair with either one particular mesh or any other synthetic mesh. Data on patients registered in the Danish Ventral Hernia Database between 2010 and 2016 were combined with administrative data from the Danish National Patient Registry. The primary outcome was operation for recurrence. Secondary outcomes were 30-day readmission, 30-day reoperation for complications (excluding hernia recurrence), and mortality after 30 and 90 days. Results: In total, 740 patients who underwent repair with one particular mesh were matched with 1479 patients who received any other synthetic mesh. The rate of repair for hernia recurrence was significantly higher in the particular mesh group than in the reference group: 12·8 versus 6·3 per cent respectively (hazard ratio 2·09, 95 per cent c.i. 1·57 to 2·79; P < 0·001). Use of the particular mesh increased the risk of readmission (odds ratio (OR) 1·53, 1·16 to 2·01; P = 0·002) and reoperation for a complication (OR 1·60, 1·03 to 2·47, P = 0·030). No difference in mortality was found. Conclusion: Clinical registries with prospectively collected data can provide long-term surveillance of commercial mesh. Laparoscopic incisional hernia repair with one particular mesh was associated with an increased rate of short-term complications and double the risk of repair for recurrence.",
author = "F Helgstrand and Thygesen, {L C} and T Bisgaard and J{\o}rgensen, {L N} and H Friis-Andersen",
note = "{\textcopyright} 2020 BJS Society Ltd Published by John Wiley & Sons Ltd.",
year = "2020",
month = aug,
day = "1",
doi = "10.1002/bjs.11562",
language = "English",
volume = "107",
pages = "1130--1136",
journal = "Archivum Chirurgicum Neerlandicum",
issn = "0007-1323",
publisher = "John/Wiley & Sons Ltd",
number = "9",

}

RIS

TY - JOUR

T1 - Differential recurrence after laparoscopic incisional hernia repair

T2 - importance of a nationwide registry-based mesh surveillance

AU - Helgstrand, F

AU - Thygesen, L C

AU - Bisgaard, T

AU - Jørgensen, L N

AU - Friis-Andersen, H

N1 - © 2020 BJS Society Ltd Published by John Wiley & Sons Ltd.

PY - 2020/8/1

Y1 - 2020/8/1

N2 - Background: Identification of suboptimal mesh products is essential to improve the outcome after hernia surgery. This study investigated whether a national clinical database combined with administrative registries may serve as a tool for postmarketing evaluation of mesh products for hernia surgery. Methods: This was a propensity score-matched case–control cohort study comparing outcomes in patients undergoing laparoscopic incisional hernia repair with either one particular mesh or any other synthetic mesh. Data on patients registered in the Danish Ventral Hernia Database between 2010 and 2016 were combined with administrative data from the Danish National Patient Registry. The primary outcome was operation for recurrence. Secondary outcomes were 30-day readmission, 30-day reoperation for complications (excluding hernia recurrence), and mortality after 30 and 90 days. Results: In total, 740 patients who underwent repair with one particular mesh were matched with 1479 patients who received any other synthetic mesh. The rate of repair for hernia recurrence was significantly higher in the particular mesh group than in the reference group: 12·8 versus 6·3 per cent respectively (hazard ratio 2·09, 95 per cent c.i. 1·57 to 2·79; P < 0·001). Use of the particular mesh increased the risk of readmission (odds ratio (OR) 1·53, 1·16 to 2·01; P = 0·002) and reoperation for a complication (OR 1·60, 1·03 to 2·47, P = 0·030). No difference in mortality was found. Conclusion: Clinical registries with prospectively collected data can provide long-term surveillance of commercial mesh. Laparoscopic incisional hernia repair with one particular mesh was associated with an increased rate of short-term complications and double the risk of repair for recurrence.

AB - Background: Identification of suboptimal mesh products is essential to improve the outcome after hernia surgery. This study investigated whether a national clinical database combined with administrative registries may serve as a tool for postmarketing evaluation of mesh products for hernia surgery. Methods: This was a propensity score-matched case–control cohort study comparing outcomes in patients undergoing laparoscopic incisional hernia repair with either one particular mesh or any other synthetic mesh. Data on patients registered in the Danish Ventral Hernia Database between 2010 and 2016 were combined with administrative data from the Danish National Patient Registry. The primary outcome was operation for recurrence. Secondary outcomes were 30-day readmission, 30-day reoperation for complications (excluding hernia recurrence), and mortality after 30 and 90 days. Results: In total, 740 patients who underwent repair with one particular mesh were matched with 1479 patients who received any other synthetic mesh. The rate of repair for hernia recurrence was significantly higher in the particular mesh group than in the reference group: 12·8 versus 6·3 per cent respectively (hazard ratio 2·09, 95 per cent c.i. 1·57 to 2·79; P < 0·001). Use of the particular mesh increased the risk of readmission (odds ratio (OR) 1·53, 1·16 to 2·01; P = 0·002) and reoperation for a complication (OR 1·60, 1·03 to 2·47, P = 0·030). No difference in mortality was found. Conclusion: Clinical registries with prospectively collected data can provide long-term surveillance of commercial mesh. Laparoscopic incisional hernia repair with one particular mesh was associated with an increased rate of short-term complications and double the risk of repair for recurrence.

UR - http://www.scopus.com/inward/record.url?scp=85082815318&partnerID=8YFLogxK

U2 - 10.1002/bjs.11562

DO - 10.1002/bjs.11562

M3 - Journal article

C2 - 32239495

VL - 107

SP - 1130

EP - 1136

JO - Archivum Chirurgicum Neerlandicum

JF - Archivum Chirurgicum Neerlandicum

SN - 0007-1323

IS - 9

ER -

ID: 59656805