Yi Kang, Guo Xujian, You Tao, Wang Yunfang, Ding Fan, Hou Xiaodong, Zhou Li
Department of Cardiovascular Surgery, Gansu Provincial Hospital.
International Congenital Heart Disease Diagnosis and Treatment Reginal Center.
Medicine (Baltimore). 2019 Sep;98(38):e17270. doi: 10.1097/MD.0000000000017270.
Atrial septal defect (ASD) is one of the most common congenital heart diseases, with an average of 1.64 per 1000 newborns with the ASD. Empirical studies suggest that surgery should be performed early in the presence of right atrium and or right ventricular enlargement, even for asymptomatic patients. Many surgical procedures can be used to treat ASD. But which method is the best choice remains unclear. This study aims to compare the efficacy and safety of standard median sternotomy, right minithoracotomy, totally thoracoscopic surgery, percutaneous closure, transcutaneous by echocardiography, and transcutaneous by radiotherapy for ASDs in children using Bayesian network meta-analysis (NMA).
We will perform a comprehensive literature search using PubMed, EMBASE.com, the Cochrane Library, Web of Science, and Chinese Biomedical Literature Database to identify relevant studies from inception to April 2019. Randomized controlled trials, prospective or retrospective cohort studies that reported the efficacy and safety of surgical procedures for the treatment of atrial septal defects will be included. Risk of bias of the included randomized controlled trials and prospective or retrospective cohort studies will be evaluated according to the Cochrane Handbook 5.1.0 and the risk of bias in non-randomized studies of interventions, respectively. A Bayesian NMA will be performed using R 3.4.1.
The results of this NMA will be submitted to a peer-reviewed journal for publication.
This NMA will summarize the direct and indirect evidence to assess the efficacy and safety of different surgical procedures for the treatment of ASDs.
Ethics approval and patient consent are not required as this study is a network meta-analysis based on published trials.
CRD42019130902.
房间隔缺损(ASD)是最常见的先天性心脏病之一,每1000例新生儿中平均有1.64例患有ASD。实证研究表明,即使是无症状患者,在出现右心房和/或右心室扩大时也应尽早进行手术。许多手术方法可用于治疗ASD。但哪种方法是最佳选择仍不清楚。本研究旨在使用贝叶斯网络荟萃分析(NMA)比较标准正中胸骨切开术、右腋下小切口、全胸腔镜手术、经皮封堵术、经超声心动图经皮封堵术和经放射治疗经皮封堵术治疗儿童ASD的疗效和安全性。
我们将使用PubMed、EMBASE.com、Cochrane图书馆、Web of Science和中国生物医学文献数据库进行全面的文献检索,以识别从开始到2019年4月的相关研究。将纳入报告房间隔缺损治疗手术疗效和安全性的随机对照试验、前瞻性或回顾性队列研究。将分别根据Cochrane手册5.1.0和干预性非随机研究中的偏倚风险评估纳入的随机对照试验以及前瞻性或回顾性队列研究的偏倚风险。将使用R 3.4.1进行贝叶斯NMA。
本NMA的结果将提交给同行评审期刊发表。
本NMA将总结直接和间接证据,以评估不同手术方法治疗ASD的疗效和安全性。
由于本研究是基于已发表试验的网络荟萃分析,因此无需伦理批准和患者同意。
PROSPERO注册号:CRD42019130902。