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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)

Authors :
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
Source :
BMJ Open, Vol 14, Iss 4 (2024)
Publication Year :
2024
Publisher :
BMJ Publishing Group, 2024.

Abstract

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.

Subjects

Subjects :
Medicine

Details

Language :
English
ISSN :
20446055
Volume :
14
Issue :
4
Database :
Directory of Open Access Journals
Journal :
BMJ Open
Publication Type :
Academic Journal
Accession number :
edsdoj.3c20a7968a1c473783c48706fc2e4500
Document Type :
article
Full Text :
https://doi.org/10.1136/bmjopen-2023-081046