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

J Trauma Acute Care Surg. 2019 Mar;86(3):524-531. doi: 10.1097/TA.0000000000002123.

Abstract

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 focused 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 EGS. 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 and 2018 were eligible for inclusion. Data on study topic, design, and funding body were collected. Interventions were classified into "perioperative", "procedural", "postoperative", "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 United States. 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 focused on high-volume conditions. More research is needed into high-mortality conditions.

Level of evidence: Systematic review, level III.

Publication types

  • Systematic Review

MeSH terms

  • Clinical Trials as Topic
  • Digestive System Surgical Procedures*
  • Emergencies*
  • Humans
  • Outcome Assessment, Health Care