Department of Endocrinology and Metabolism, Tianjin Medical University General Hospital, Tianjin, China.
Laboratory of Psychiatric Neuroimaging, Tianjin Municipal Mental Health Center, Tianjin, China.
BMJ Open. 2019 Apr 4;9(4):e028430. doi: 10.1136/bmjopen-2018-028430.
Bariatric surgeries are effective in treating obesity related comorbidities, including type 2 diabetes mellitus. More robust evidence is needed to facilitate choice of procedure. In this systemic review, we aim to investigate the comparative long-term effectiveness in inducing remission of type 2 diabetes, halting diabetic complications, reducing mortality and the safety of conventional and emerging bariatric surgeries.
Databases including Cochrane Central Register, EMBASE, MEDLINE and clinical trial registries will be searched for randomised controlled trials with at least 3 years of follow-up, including direct and/or indirect evidence regarding primary bariatric surgeries in overweight or obese adults with type 2 diabetes mellitus, from inception of each database to 2019, with no language or publication type limits imposed. Dual selection of studies, data extraction and risk of bias assessments will be performed. Primary outcomes include full diabetes remission, composite outcome of full or partial diabetes remission and adverse event profiles. Secondary outcomes include anthropometric measurements, cardiovascular risk factor burden, medication burden, diabetic complications and all-cause mortality. Given sufficient homogeneity, network meta-analyses will be performed in a random-effects model based on the Bayesian framework, while assessing for consistency between direct and indirect estimates. Heterogeneities of studies will be explored through meta-regression analysis, and robustness of findings will be checked by sensitivity analysis, and an alternative method under a frequentist framework. All statistical analysis and graphical presentations will be conducted by R software V.3.3.3 (The R Project for Statistical Computing). The overall quality of the evidence will be assessed using the Grading of Recommendations, Assessment, Development and Evaluation criteria for each outcome.
Ethics approval is not required as individual patient data will not be included. This review will be subject for publication in a peer reviewed journal.
CRD42018110775.
减重手术在治疗肥胖相关合并症方面非常有效，包括 2 型糖尿病。为了方便手术选择，需要更有力的证据。在这项系统评价中，我们旨在调查比较长期的有效性，以诱导 2 型糖尿病缓解、阻止糖尿病并发症、降低死亡率以及传统和新兴减重手术的安全性。
我们将搜索包括 Cochrane 中央注册库、EMBASE、MEDLINE 和临床试验注册库在内的数据库，以查找至少有 3 年随访的随机对照试验，这些试验包括超重或肥胖的 2 型糖尿病患者的主要减重手术的直接和/或间接证据，从每个数据库的开始到 2019 年，不限制语言或出版类型。将进行双重研究选择、数据提取和偏倚风险评估。主要结局包括糖尿病完全缓解、糖尿病完全或部分缓解的复合结局和不良事件概况。次要结局包括人体测量测量、心血管危险因素负担、药物负担、糖尿病并发症和全因死亡率。鉴于足够的同质性，将根据贝叶斯框架在随机效应模型中进行网络荟萃分析，同时评估直接和间接估计之间的一致性。通过元回归分析探索研究之间的异质性，并通过敏感性分析和频繁主义框架下的替代方法检查结果的稳健性。所有统计分析和图形演示将使用 R 软件 V.3.3.3（用于统计计算的 R 项目）进行。将使用推荐评估、制定和评估（GRADE）标准对每个结局的证据进行总体质量评估。
不需要伦理批准，因为不会包含个体患者数据。本综述将在同行评审期刊上发表。
PROSPERO 注册号：CRD42018110775。
