Systematic review on reporting of components and outcomes in randomized clinical trials of paraoesophageal hernia mesh repair

Abstract

Background: 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. Methods: 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. Results: 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. Conclusion: 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.