National multicenter prospective observational study “The role of concomitant diseases in poSTOPerative complications RISK stratification — STOPRISK”: study protocol

Abstract

INTRODUCTION: Advances in modern anesthesiology have significantly reduced the risk of anesthesia compared to the last century, however, the level of perioperative in-hospital mortality after elective major abdominal surgery is still high at the moment. Poor outcome prediction is the cornerstone of individualized perioperative management of high-risk patients aimed at preventing complications. Despite the fact that a large number of risk assessment tools have been developed over the past decades, the accuracy of the forecast is still far from required. According to the literature data, models based on the study of risk factors in the national population of patients, of which comorbidities make the greatest contribution, have the greatest accuracy. MATERIALS AND METHODS: Design: prospective observational study. Setting: National multicenter study of patients in surgical hospitals. Patients: Patients undergoing abdominal surgery. Interventions: Not provided. RESULTS: The developed design was registered in the ClinicalTrials.gov database, a study organized by the Federation of Anesthesiologists and Resuscitators of Russia in cooperation with the Kuban State Medical University has now begun, 38 centers are participating in it, two papers have been published based on the results of an interim analysis. CONCLUSIONS: The study is of great scientific and medical and social importance, as a result of the analysis of the data obtained, the role of concomitant diseases in the development of an adverse outcome will be studied and a national risk assessment model will be developed. REGISTRATION: Clinicaltrials.gov identifier: NCT03945968. Registered May 10, 2019.