Protocol for an independent patient data meta-analysis of prophylactic mesh placement for incisional hernia prevention after abdominal aortic aneurysm surgery: a collaborative European Hernia Society project (I-PREVENT-AAA)
Introduction Incisional hernia (IH) is a prevalent and potentially dangerous complication of abdominal surgery, especially in high-risk groups. Mesh reinforcement of the abdominal wall has been studied as a potential intervention to prevent IHs. Randomised controlled trials (RCTs) have demonstrated...
| Main Authors: | , , , , , , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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BMJ Publishing Group
2024-04-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/14/4/e081046.full |
| _version_ | 1797204380452126720 |
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| author | Tilo Kölbel Pieter J Tanis Antonia Zapf Olivier Detry Jonothan J Earnshaw Filip Muysoms Wolfgang Reinpold Rudolf van den Berg Floris P J den Hartog Christina Bali Miltiadis Matsagkas Paul M Bevis Eike S Debus Susanne Honig Frederik Berrevoet Cesare Stabilini Holger Diener Eric Bibiza‑Freiwald Vaia K Georvasili |
| author_facet | Tilo Kölbel Pieter J Tanis Antonia Zapf Olivier Detry Jonothan J Earnshaw Filip Muysoms Wolfgang Reinpold Rudolf van den Berg Floris P J den Hartog Christina Bali Miltiadis Matsagkas Paul M Bevis Eike S Debus Susanne Honig Frederik Berrevoet Cesare Stabilini Holger Diener Eric Bibiza‑Freiwald Vaia K Georvasili |
| collection | DOAJ |
| description | Introduction Incisional hernia (IH) is a prevalent and potentially dangerous complication of abdominal surgery, especially in high-risk groups. Mesh reinforcement of the abdominal wall has been studied as a potential intervention to prevent IHs. Randomised controlled trials (RCTs) have demonstrated that prophylactic mesh reinforcement after abdominal surgery, in general, is effective and safe. In patients with abdominal aortic aneurysm (AAA), prophylactic mesh reinforcement after open repair has not yet been recommended in official guidelines, because of relatively small sample sizes in individual trials. Furthermore, the identification of subgroups that benefit most from prophylactic mesh placement requires larger patient numbers. Our primary aim is to evaluate the efficacy and effectiveness of the use of a prophylactic mesh after open AAA surgery to prevent IH by performing an individual patient data meta-analysis (IPDMA). Secondary aims include the evaluation of postoperative complications, pain and quality of life, and the identification of potential subgroups that benefit most from prophylactic mesh reinforcement.Methods and analysis We will conduct a systematic review to identify RCTs that study prophylactic mesh placement after open AAA surgery. Cochrane Central Register of Controlled Trials, MEDLINE Ovid, Embase, Web of Science Core Collection and Google Scholar will be searched from the date of inception onwards. RCTs must directly compare primary sutured closure with mesh closure in adult patients who undergo open AAA surgery. Lead authors of eligible studies will be asked to share individual participant data (IPD). The risk of bias (ROB) for each included study will be assessed using the Cochrane ROB tool. An IPDMA will be performed to evaluate the efficacy, with the IH rate as the primary outcome. Any signs of heterogeneity will be evaluated by Forest plots. Time-to-event analyses are performed using Cox regression analysis to evaluate risk factors.Ethics and dissemination No new data will be collected in this study. We will adhere to institutional, national and international regulations regarding the secure and confidential sharing of IPD, addressing ethics as indicated. We will disseminate findings via international conferences, open-source publications in peer-reviewed journals and summaries posted online.PROSPERO registration number CRD42022347881. |
| first_indexed | 2024-04-24T08:34:18Z |
| format | Article |
| id | doaj.art-3c20a7968a1c473783c48706fc2e4500 |
| institution | Directory Open Access Journal |
| issn | 2044-6055 |
| language | English |
| last_indexed | 2024-04-24T08:34:18Z |
| publishDate | 2024-04-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj.art-3c20a7968a1c473783c48706fc2e45002024-04-16T18:00:08ZengBMJ Publishing GroupBMJ Open2044-60552024-04-0114410.1136/bmjopen-2023-081046Protocol for an independent patient data meta-analysis of prophylactic mesh placement for incisional hernia prevention after abdominal aortic aneurysm surgery: a collaborative European Hernia Society project (I-PREVENT-AAA) 0Tilo Kölbel1Pieter J Tanis2Antonia Zapf3Olivier Detry4Jonothan J Earnshaw5Filip Muysoms6Wolfgang Reinpold7Rudolf van den Berg8Floris P J den Hartog9Christina Bali10Miltiadis Matsagkas11Paul M Bevis12Eike S Debus13Susanne Honig14Frederik Berrevoet15Cesare Stabilini16Holger DienerEric Bibiza‑FreiwaldVaia K GeorvasiliDivision of Surgery & Interventional Science, University College London, London, UK4 Department of Vascular Medicine, University Heart Center Hamburg, Hamburg, GermanySurgery, Amsterdam UMC,University of Amsterdam, Amsterdam, The Netherlands2 Institute of Medical Biometry and Epidemiology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany5 Department of Abdominal Surgery and Transplantation, Central University Hospital of Liege, Liege, BelgiumNHS Abdominal Aortic Aneurysm Screening Programme, Department of Vascular Surgery, Gloucestershire Royal Hospital, Gloucester, UKMaria Middelares, Ghent, BelgiumGross Sand Hospital, Hamburg, UK1 Department of Surgery, Erasmus University Medical Centre, Rotterdam, The Netherlands1 Department of Surgery, Erasmus University Medical Centre, Rotterdam, The Netherlands3 Department of Surgery, University Hospital of Ioannina, Ioannina, Greece4 Department of Vascular Surgery, University of Thessaly, Larissa, Greece5 Department of Vascular Surgery, North Bristol NHS Trust, Westbury on Trym, UK7 Department of Vascular Medicine, University Medical Center Hamburg-Eppendorf University Heart & Vascular Center, Eppendorf, Hamburg, Germany8 Department of Vascular Surgery, Hospital Robert Schuman Kirchberg Hospital, Luxembourg City, Luxembourg9 Department of General and Hepatobiliary Surgery and Liver Transplantation, Ghent University Hospital, Ghent, Belgium11 Department of Surgical Sciences, University of Genoa, Genoa, ItalyIntroduction Incisional hernia (IH) is a prevalent and potentially dangerous complication of abdominal surgery, especially in high-risk groups. Mesh reinforcement of the abdominal wall has been studied as a potential intervention to prevent IHs. Randomised controlled trials (RCTs) have demonstrated that prophylactic mesh reinforcement after abdominal surgery, in general, is effective and safe. In patients with abdominal aortic aneurysm (AAA), prophylactic mesh reinforcement after open repair has not yet been recommended in official guidelines, because of relatively small sample sizes in individual trials. Furthermore, the identification of subgroups that benefit most from prophylactic mesh placement requires larger patient numbers. Our primary aim is to evaluate the efficacy and effectiveness of the use of a prophylactic mesh after open AAA surgery to prevent IH by performing an individual patient data meta-analysis (IPDMA). Secondary aims include the evaluation of postoperative complications, pain and quality of life, and the identification of potential subgroups that benefit most from prophylactic mesh reinforcement.Methods and analysis We will conduct a systematic review to identify RCTs that study prophylactic mesh placement after open AAA surgery. Cochrane Central Register of Controlled Trials, MEDLINE Ovid, Embase, Web of Science Core Collection and Google Scholar will be searched from the date of inception onwards. RCTs must directly compare primary sutured closure with mesh closure in adult patients who undergo open AAA surgery. Lead authors of eligible studies will be asked to share individual participant data (IPD). The risk of bias (ROB) for each included study will be assessed using the Cochrane ROB tool. An IPDMA will be performed to evaluate the efficacy, with the IH rate as the primary outcome. Any signs of heterogeneity will be evaluated by Forest plots. Time-to-event analyses are performed using Cox regression analysis to evaluate risk factors.Ethics and dissemination No new data will be collected in this study. We will adhere to institutional, national and international regulations regarding the secure and confidential sharing of IPD, addressing ethics as indicated. We will disseminate findings via international conferences, open-source publications in peer-reviewed journals and summaries posted online.PROSPERO registration number CRD42022347881.https://bmjopen.bmj.com/content/14/4/e081046.full |
| spellingShingle | Tilo Kölbel Pieter J Tanis Antonia Zapf Olivier Detry Jonothan J Earnshaw Filip Muysoms Wolfgang Reinpold Rudolf van den Berg Floris P J den Hartog Christina Bali Miltiadis Matsagkas Paul M Bevis Eike S Debus Susanne Honig Frederik Berrevoet Cesare Stabilini Holger Diener Eric Bibiza‑Freiwald Vaia K Georvasili Protocol for an independent patient data meta-analysis of prophylactic mesh placement for incisional hernia prevention after abdominal aortic aneurysm surgery: a collaborative European Hernia Society project (I-PREVENT-AAA) BMJ Open |
| title | Protocol for an independent patient data meta-analysis of prophylactic mesh placement for incisional hernia prevention after abdominal aortic aneurysm surgery: a collaborative European Hernia Society project (I-PREVENT-AAA) |
| title_full | Protocol for an independent patient data meta-analysis of prophylactic mesh placement for incisional hernia prevention after abdominal aortic aneurysm surgery: a collaborative European Hernia Society project (I-PREVENT-AAA) |
| title_fullStr | Protocol for an independent patient data meta-analysis of prophylactic mesh placement for incisional hernia prevention after abdominal aortic aneurysm surgery: a collaborative European Hernia Society project (I-PREVENT-AAA) |
| title_full_unstemmed | Protocol for an independent patient data meta-analysis of prophylactic mesh placement for incisional hernia prevention after abdominal aortic aneurysm surgery: a collaborative European Hernia Society project (I-PREVENT-AAA) |
| title_short | Protocol for an independent patient data meta-analysis of prophylactic mesh placement for incisional hernia prevention after abdominal aortic aneurysm surgery: a collaborative European Hernia Society project (I-PREVENT-AAA) |
| title_sort | protocol for an independent patient data meta analysis of prophylactic mesh placement for incisional hernia prevention after abdominal aortic aneurysm surgery a collaborative european hernia society project i prevent aaa |
| url | https://bmjopen.bmj.com/content/14/4/e081046.full |
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