P-084 independent patient data meta-analysis of randomized controlled trials on prophylactic mesh placement for incisional hernia prevention: study protocol

Abstract Aim In high risk groups such as patients undergoing open abdominal aortic aneurysm (AAA) surgery, the risk of incisional hernia (IH) formation is up to 69%. IH can be prevented through prophylactic mesh augmentation (PMA). Several randomized controlled trials (RCT) have shown a significant decrease in IH formation after PMA. However, due to study design and sample size issues, implementation of PMA into daily practice is lacking. Methods International collaboration will be initiated under the guidance of the European Hernia Society. RCTs studying PMA after open AAA surgery will be identified through a literature search. Corresponding authors of the selected studies will be approached for participation by e-mail, telephone or other means. Where independent patient data (IPD) are available, a suitable data delivery agreement (DDA) will be drafted and signed upon agreement. Pseudonymised or anonymised data sets will be securely transferred and stored, and relevant study parameters will be harmonized. A 1-stage IPD meta-analysis (IPDMA) will be performed, stratified per centre, assessing PMA effectivity according to the intention-to-treat principle. If a 1-stage IPDMA is not feasible, a 2-step IPDMA will be performed, analysing each RCT separately and pooling outcomes. Results will be published in internationally recognized, peer-reviewed journals. This study protocol was registered under PROSPERO number CRD42022347881. Conclusions Gathering IPD across relevant RCTs and performing an IPDMA on the combined data will help to better establish effectiveness of PMA in preventing IH after open AAA surgery. Secondarily, subgroup analyses will allow identification of patients who will benefit from PMA most.