UCL Division of Surgery and Interventional Science, Royal Free Hospital, 9th Floor, Pond Street, London, NW3 2QG, UK.
Department of Plastic and Reconstructive Surgery, Royal Free Hospital, London, UK.
Syst Rev. 2018 Nov 13;7(1):186. doi: 10.1186/s13643-018-0871-x.
A patent microvascular anastomosis is of paramount importance in free tissue transfer. Anastomotic coupler devices provide an alternative to technically demanding hand-sewn venous anastomosis. Various advantages of these devices have been discussed but previous systematic reviews had methodological flaws or did not perform a meta-analysis. This review aims to evaluate the quality of the evidence and quantify the efficacy and safety of venous couplers compared to hand-sewn anastomosis.
A PRISMA-compliant systematic review and meta-analysis will be performed. A comprehensive search strategy has been developed and will be applied to the databases MEDLINE and Embase from inception to October 2018. All clinical studies using anastomotic coupler devices for venous anastomoses in free tissue transfer will be eligible for inclusion. Screening of studies and data extraction will be performed independently by two authors. Our primary outcome is anastomotic venous thrombosis. Secondary outcomes will include time to complete the venous anastomosis, tearing of veins, anastomotic leakage, flap loss/failure and fiscal outcomes. The risk of bias for included studies will be assessed by using the ROBINS-I tool, and recommendations based on the evidence will be made using the GRADE approach. Descriptive statistical analyses will be used and if two or more studies report the same outcome, data will be pooled for comparative analysis. A direct comparison meta-analysis will be performed if possible.
There has been no comparison of coupled and hand-sewn venous anastomoses using a robust and validated methodology preceded by a protocol and performing meta-analysis. Included studies are expected to be mainly observational and prone to bias; however, there is value in summarising the evidence, assessing its risk of bias and performing meta-analysis to guide clinicians. By using a broad approach including all types of flaps, we foresee inherent differences regarding the unit of analysis and different anatomic sites. This will limit the validity of our conclusions but is unavoidable. We will seek unpublished data from authors and perform subgroup analysis where appropriate. Limitations and areas of uncertainty will be discussed to guide future research.
PROSPERO CRD42018110111.
在游离组织移植中，专利的微血管吻合至关重要。吻合器装置为技术要求较高的手工静脉吻合提供了一种替代方法。这些装置具有各种优势，已经进行了讨论，但之前的系统评价存在方法学缺陷或没有进行荟萃分析。本综述旨在评估证据质量，并量化与手工吻合相比，静脉吻合器的疗效和安全性。
我们将进行一项符合 PRISMA 标准的系统评价和荟萃分析。已经制定了全面的搜索策略，并将应用于从开始到 2018 年 10 月的 MEDLINE 和 Embase 数据库。所有使用吻合器装置进行游离组织移植中静脉吻合的临床研究都将有资格纳入。两名作者将独立进行研究筛选和数据提取。我们的主要结局是吻合静脉血栓形成。次要结局包括完成静脉吻合的时间、静脉撕裂、吻合口渗漏、皮瓣丢失/失败和财政结果。使用 ROBINS-I 工具评估纳入研究的偏倚风险，并使用 GRADE 方法基于证据提出建议。将使用描述性统计分析，如果有两个或更多研究报告相同的结局，将对数据进行汇总进行比较分析。如果可能，将进行直接比较荟萃分析。
以前没有使用经过验证的稳健方法对耦合和手工静脉吻合进行比较，也没有在制定方案和进行荟萃分析之前进行比较。预计纳入的研究主要是观察性研究，容易存在偏倚；然而，总结证据、评估其偏倚风险并进行荟萃分析以指导临床医生是有价值的。通过使用包括所有类型皮瓣的广泛方法，我们预见在分析单位和不同解剖部位方面存在固有差异。这将限制我们结论的有效性，但这是不可避免的。我们将向作者索取未发表的数据，并在适当的情况下进行亚组分析。将讨论局限性和不确定性领域，以指导未来的研究。
PROSPERO CRD42018110111。
