PROSPERO International prospective register of systematic reviews

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1 PROSPERO International prospective register of systematic reviews Percutaneous access for endovascular aortic aneurysm repair: a systematic review and meta-analysis Shahin Hajibandeh, Shahab Hajibandeh, Stavros A Antoniou, Emma Child, Francesco Torella, George A Antoniou Citation Shahin Hajibandeh, Shahab Hajibandeh, Stavros A Antoniou, Emma Child, Francesco Torella, George A Antoniou. Percutaneous access for endovascular aortic aneurysm repair: a systematic review and meta-analysis. PROSPERO 2015:CRD Available from Review question(s) Is percutaneous approach associated with better outcomes than conventional surgical access for standard endovascular aneurysm repair (EVAR) or thoracic EVAR (TEVAR) in patients with abdominal aortic aneurysm (AAA) or thoracic aortic aneurysm (TAA)? Searches Two review authors (Shahin H, Shahab H) will independently search the following electronic databases: MEDLINE, EMBASE, CINAHL and the Cochrane Central Register of Controlled Trials (CENTRAL). The details of the search strategy, which will be adapted according to thesaurus headings, search operators and limits in each of the above databases, can be found in the accompanying PDF document. In addition, the following trial databases will be searched for details of ongoing and unpublished studies: World Health Organization International Clinical Trials Registry ClinicalTrials.gov ISRCTN Register We will search the bibliographic lists of relevant articles and reviews for further potentially eligible studies. Moreover, we plan to hand search the leading journals in vascular and endovascular surgery such as Journal of Vascular Surgery, European Journal of Vascular and Endovascular Surgery, and Journal of Endovascular Therapy. Also, if appropriate, we intend to contact any other experts or key authors in the field. Link to search strategy Types of study to be included Randomised controlled trials and observational studies comparing percutaneous EVAR with open EVAR or TEVAR. Condition or domain being studied We will evaluate outcomes of percutaneous approach versus conventional surgical access for standard EVAR or TEVAR in patients with AAA or TAA. Participants/ population Patients with AAA or TAA undergoing percutaneous EVAR, open EVAR or TEVAR Intervention(s), exposure(s) Percutaneous EVAR with any percutaneous closure device Comparator(s)/ control Page: 1 / 5

2 Surgical exposure of the femoral vessels through longitudinal or oblique skin incisions for EVAR or TEVAR. Fascia suture technique for closure (fascial closure) of femoral artery access sites. Outcome(s) Primary outcomes 1. Procedure success rate (successful exclusion of aneurysm and obtaining haemostasis at the access site without the need for conversion to surgical exposure of the femoral vessels) 2. Groin infection 3. Groin haematoma 4. Arterial occlusion/thrombosis/stenosis/dissection 5. Pseudoaneurysm 6. Lymphocele At the end of follow-up period mentioned in each included study Secondary outcomes 1. Procedure time 2. Blood loss 3. Length of hospital stay 4. All-cause mortality 5. Cardiovascular mortality 6. Myocardial infarction (MI), stroke, and renal failure At the end of follow-up period mentioned in each included study Data extraction, (selection and coding) We will create an electronic data extraction spreadsheet in line with the Cochrane data collection form for intervention reviews. We will pilot-test the spreadsheet in randomly selected articles and adjust it accordingly. Our data extraction spreadsheet will include: Study-related data (first author, year of publication, country of origin of the corresponding author, journal in which the study was published, study design, study size, clinical condition of the study participants, type of intervention) Baseline demographic and clinical information of the trial populations (age, gender, smoking, hypertension, diabetes mellitus, coronary artery disease, and cerebrovascular disease ) Access-related information: selection/inclusion criteria used in the included studies for recruitment, exclusion parameters and ultrasound (US)-guided vs. non-us-guided access. Primary and secondary outcome data Two review authors (Shahin H and Shahab H) will independently collect and record data in the data extraction spreadsheet and we will resolve disagreements by discussion. If no agreement can be reached, a third review author (GA) will be consulted. Risk of bias (quality) assessment Page: 2 / 5

3 We will use the Cochrane Collaboration s tool for assessing risk of bias in randomised controlled trials and the Newcastle-Ottawa scale for assessing risk of bias in observational studies. The risk of bias for each included study will be assessed independently by two review authors (Shahin H and Shahab H). We will assess all domains (selection bias, performance bias, detection bias, attrition bias, reporting bias and other sources of bias) and for each individual domain, we will classify studies into low, unclear, and high risk of bias. We will resolve disagreements by discussion between the two review authors (Shahin H and Shahab H). If no agreement can be reached, a third reviewer (FT) will act as an adjudicator. Strategy for data synthesis We will use Review Manager 5.3 software and Comprehensive Meta-Analysis 2.0 software for data synthesis. The extracted data will be entered into Review Manager by an independent reviewer (Shahin H) and checked by a second independent reviewer (Shahab H). Moreover, the extracted data will be entered into Comprehensive Meta-Analysis 2.0 software by an independent reviewer (GA). We will use multiple treatment comparison meta-analysis (network metaanalysis) as we aim to evaluate the same outcome parameters in three intervention groups. We will use random-effects or fixed effect modelling as appropriate, for analysis. We will apply random effects models if considerable heterogeneity among the studies, as defined by Higgins et al, is identified. The results will be reported in a forest plot with 95% confidence intervals (CIs). Analysis of subgroups or subsets We plan to perform separate analyses for the following subgroups: EVAR TEVAR Contact details for further information Dr Shahin Hajibandeh Liverpool Vascular and Endovascular Service Royal Liverpool University Hospital Liverpool L7 8XP shahin_hajibandeh@yahoo.com Organisational affiliation of the review Liverpool Vascular and Endovascular Service Review team Dr Shahin Hajibandeh, Liverpool Vascular and Endovascular Service, Royal Liverpool University Hospital, Liverpool, Dr Shahab Hajibandeh, Liverpool Vascular and Endovascular Service, Royal Liverpool University Hospital, Liverpool, Dr Stavros A Antoniou, Department of General Surgery, University Hospital of Heraklion, University of Crete, Heraklion, Greece Ms Emma Child, University Hospital Aintree Mr Francesco Torella, Liverpool Vascular and Endovascular Service, Royal Liverpool University Hospital, Liverpool, Mr George A Antoniou, Liverpool Vascular and Endovascular Service, Royal Liverpool University Hospital, Liverpool, Page: 3 / 5

4 Anticipated or actual start date 19 May 2015 Anticipated completion date 10 July 2015 Funding sources/sponsors None Conflicts of interest None known Language English Country England Subject index terms status Subject indexing assigned by CRD Subject index terms Aortic Aneurysm, Abdominal; Humans; Vascular Surgical Procedures Stage of review Completed and published Date of registration in PROSPERO 21 May 2015 Date of publication of this revision 05 April 2016 Details of final report/publication(s) Hajibandeh S, Hajibandeh S, Antoniou SA, Child E, Torella F, Antoniou GA. Percutaneous access for endovascular aortic aneurysm repair: A systematic review and meta-analysis. Vascular, 2016 Mar 21. pii: DOI /CRD Stage of review at time of this submission Started Completed Preliminary searches Yes Yes Piloting of the study selection process Yes Yes Formal screening of search results against eligibility criteria Yes Yes Data extraction Yes Yes Risk of bias (quality) assessment Yes Yes Data analysis Yes Yes PROSPERO International prospective register of systematic reviews The information in this record has been provided by the named contact for this review. CRD has accepted this information in good Page: 4 / 5

5 Powered by TCPDF ( faith and registered the review in PROSPERO. CRD bears no responsibility or liability for the content of this registration record, any associated files or external websites. Page: 5 / 5