Regional Oesophagogastric Unit, Royal Surrey County Hospital, Guildford, UK.
Br J Surg. 2021 Apr 5;108(3):256-264. doi: 10.1093/bjs/znaa107.
Surgical interventions, such as paraoesophageal hernia (POH) repair, are complex with multiple components that require consideration in the reporting of clinical trials. Many aspects of POH repair, including mesh hiatal reinforcement and fundoplication type, are contentious. This review summarizes the reporting of components and outcomes in RCTs of POH repair.
Systematic searches identified RCTs of POH repair published from 1995 to 2020. The patient selection criteria for RCT involvement were noted. The components of the surgical interventions in these RCTs were recorded using the CONSORT guidelines for non-pharmacological treatments, Template for Intervention Description and Replication (TIDieR) and Blencowe frameworks. The outcomes were summarized and definitions sought for critical variables, including recurrence.
Of 1918 abstracts and 21 screened full-text articles, 12 full papers reporting on six RCTs were included in the review. The patient selection criteria and definitions of POH between trials varied considerably. Although some description of trial interventions was provided in all RCTs, this varied in depth and detail. Four RCTs described efforts to standardize the trial intervention. Outcomes were reported inconsistently, were rarely defined fully, and overall trial conclusions varied during follow-up.
This lack of detail on the surgical intervention in POH repair RCTs prevents full understanding of what exact procedure was evaluated and how it should be delivered in clinical practice to gain the desired treatment effects. Improved focus on the definitions, descriptions and reporting of surgical interventions in POH repair is required for better future RCTs.
外科干预，如食管裂孔疝（POH）修复，具有多个需要在临床试验报告中考虑的复杂组成部分。POH 修复的许多方面，包括网片食管裂孔加强和胃底折叠术类型，都存在争议。本综述总结了 POH 修复 RCT 中组成部分和结果的报告情况。
系统搜索确定了 1995 年至 2020 年发表的 POH 修复 RCT。记录了 RCT 参与的患者选择标准。使用 CONSORT 指南（非药物治疗）、TIDieR 模板和 Blencowe 框架记录了这些 RCT 中外科干预的组成部分。总结了结果，并为关键变量（包括复发）寻求定义。
在 1918 篇摘要和 21 篇筛选的全文文章中，有 12 篇全文论文报告了 6 项 RCT，纳入本综述。试验之间的患者选择标准和 POH 定义差异很大。尽管所有 RCT 都对试验干预进行了一定程度的描述，但深度和细节却有所不同。四项 RCT 描述了为标准化试验干预所做的努力。结果报告不一致，很少有充分的定义，并且在随访期间总体试验结论有所不同。
POH 修复 RCT 中对手术干预缺乏详细描述，使得人们无法完全了解评估的确切手术程序，以及如何在临床实践中实施以获得所需的治疗效果。需要更加关注 POH 修复中手术干预的定义、描述和报告，以提高未来 RCT 的质量。
