The current status of clinical trials in emergency gastrointestinal surgery. A systematic analysis of contemporary clinical trials

Background Emergency gastrointestinal surgery (EGS) conditions represent a significant healthcare burden globally requiring emergency operations that are associated with mortality rates as high as 80%. EGS is currently focussed on quality improvement and internal audits, which occurs at a national or local level. An appreciation of what EGS trials are being conducted is important to reduce research wastage and develop coordinated research strategies in surgery. The primary aim of this study was to identify and quantify recent and active trials in emergency gastrointestinal surgery. The secondary aim was to identify conditions of interest, and which aspects of care were being modified. Methods A systematic search of WHO, UK, US, Australian and Canadian trials databases was undertaken using broad terms to identify studies addressing emergency abdominal surgery and specific high-risk diagnoses. Studies registered between 2013-2018 were eligible for inclusion. Data on study topic, design, and funding body were collected. Interventions were classified into ‘peri-operative’, ‘procedural’, ‘post-operative’, ‘non-surgical’ and ‘other’ categories. Results Searches identified 5603 registered trials. After removal of duplicates, 4492 studies remained and 42 were eligible for inclusion. Almost 50% of trials were located in Europe and 17% (n=7) in the USA. The most common condition addressed was acute appendicitis (n=11), with the most common intervention being procedure based (n=23). Hospital based funding was the most common funder (n=30). Conclusion There is large disparity in the number of surgical trials in emergency surgery, which are primarily focussed on high-volume conditions. More research is needed into high-mortality conditions. Evidence level 1a (oxford) Corresponding author: Mr Matthew Lee, Dept of General Surgery, Northern General Hospital, Sheffield, UK, S5 7AU, Twitter: @wannabehawkeye, Email:m.j.lee@sheffield.ac.uk, Telephone: (+44) 01142 434 343, Category: Systematic review Declarations Ethics: This study did not utilise patient data and therefore no ethical approval was required. Consent for publication: This study did not utilise patient data and therefore did not require any consent from patients for publication. Availability of data and material: Data is available on request to investigators and is presented in Table 1. Competing interests: No competing interests. Funding: This study is unfunded. Authors contributions: All authors contributed equally to all aspects of the work. MJL is the study guarantor. Acknowledgments: None. © 2018 Lippincott Williams & Wilkins, Inc.

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