학술논문
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).
Document Type
Academic Journal
Author
van den Berg R; Department of Surgery, Erasmus University Medical Centre, Rotterdam, The Netherlands r.vandenberg.4@erasmusmc.nl.; Medicine, Erasmus University Rotterdam, Rotterdam, The Netherlands.; den Hartog FPJ; Department of Surgery, Erasmus University Medical Centre, Rotterdam, The Netherlands.; Bali C; Department of Surgery, University Hospital of Ioannina, Ioannina, Greece.; Matsagkas M; Department of Vascular Surgery, University of Thessaly, Larissa, Greece.; Bevis PM; Department of Vascular Surgery, North Bristol NHS Trust, Westbury on Trym, UK.; Earnshaw JJ; Department of Vascular Surgery, Gloucestershire Hospitals NHS Foundation Trust, Cheltenham, UK.; Debus ES; Department of Vascular Medicine, University Medical Center Hamburg-Eppendorf University Heart & Vascular Center, Eppendorf, Hamburg, Germany.; Honig S; Department of Vascular Surgery, Hospital Robert Schuman Kirchberg Hospital, Luxembourg City, Luxembourg.; Berrevoet F; Department of General and Hepatobiliary Surgery and Liver Transplantation, Ghent University Hospital, Ghent, Belgium.; Detry O; Department of Abdominal Surgery and Transplantation, Division of Abdominal Wall Surgery, CHU Liege, University of Liege, Liege, Belgium.; Stabilini C; Department of Surgical Sciences, University of Genoa, Genoa, Italy.; Muysoms F; Department of Surgery, AZ Maria Middelares Hospital, Ghent, Belgium.; Tanis PJ; Department of Surgery, Erasmus University Medical Centre, Rotterdam, The Netherlands.
Source
Publisher: BMJ Publishing Group Ltd Country of Publication: England NLM ID: 101552874 Publication Model: Electronic Cited Medium: Internet ISSN: 2044-6055 (Electronic) Linking ISSN: 20446055 NLM ISO Abbreviation: BMJ Open Subsets: MEDLINE
Subject
Language
English
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.
Competing Interests: Competing interests: Participating authors of the I-PREVENT study have previously worked on the PRIMA and PRIMAAT trials. These authors will be excluded from doing quality evaluation and data extraction of relevant trials. No further statements of competing interests need to be disclosed.
(© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY. Published by BMJ.)
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.
Competing Interests: Competing interests: Participating authors of the I-PREVENT study have previously worked on the PRIMA and PRIMAAT trials. These authors will be excluded from doing quality evaluation and data extraction of relevant trials. No further statements of competing interests need to be disclosed.
(© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY. Published by BMJ.)