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).
van den Berg, Rudolf; den Hartog, Floris P J; Bali, Christinaet al.
Adolescent; PREVENTIVE MEDICINE; SURGERY; General Medicine
Abstract :
[en] [en] 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.
Disciplines :
Surgery
Author, co-author :
van den Berg, Rudolf ; Department of Surgery, Erasmus University Medical Centre, Rotterdam, The Netherlands r.vandenberg.4@erasmusmc.nl ; Medicine, Erasmus University Rotterdam, Rotterdam, The Netherlands
den Hartog, Floris P J; Department of Surgery, Erasmus University Medical Centre, Rotterdam, The Netherlands
Bali, Christina; Department of Surgery, University Hospital of Ioannina, Ioannina, Greece
Matsagkas, Miltiadis; Department of Vascular Surgery, University of Thessaly, Larissa, Greece
Bevis, Paul M; Department of Vascular Surgery, North Bristol NHS Trust, Westbury on Trym, UK
Earnshaw, Jonothan J; Department of Vascular Surgery, Gloucestershire Hospitals NHS Foundation Trust, Cheltenham, UK
Debus, Eike S; Department of Vascular Medicine, University Medical Center Hamburg-Eppendorf University Heart & Vascular Center, Eppendorf, Hamburg, Germany
Honig, Susanne; Department of Vascular Surgery, Hospital Robert Schuman Kirchberg Hospital, Luxembourg City, Luxembourg
Berrevoet, Frederik; Department of General and Hepatobiliary Surgery and Liver Transplantation, Ghent University Hospital, Ghent, Belgium
Detry, Olivier ; Université de Liège - ULiège > Département des sciences cliniques > Pathologie chirurgicale abdominale et endocrinienne
Stabilini, Cesare; Department of Surgical Sciences, University of Genoa, Genoa, Italy
Muysoms, Filip; Department of Surgery, AZ Maria Middelares Hospital, Ghent, Belgium
Tanis, Pieter J; Department of Surgery, Erasmus University Medical Centre, Rotterdam, The Netherlands
European Hernia Society Prophylactic mesh study group collaborators
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).
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