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Dynamic Postoperative Trends for Early Detection of Complications After Gastrointestinal Surgery

Study acronym: DYNAMIC-GI
StatusNot Yet Recruiting
PhaseNot specified
Started
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Record History

  1. Minor Study First Submitted
Postoperative complications after gastrointestinal (GI) surgery remain a major source of morbidity, mortality, prolonged hospitalisation, and healthcare costs. Early identification of complications is essential to reduce the burden of this issue on individual patients and the healthcare system. In the immediate postoperative period, clinical parameters and laboratory biomarkers, particularly inflammatory markers such as white blood cell count, C-reactive protein (CRP), and procalcitonin (PCT), may be altered as a result of an evolving surgical complication, but may also reflect the physiological inflammatory response to surgical trauma. In daily clinical practice, clinicians are frequently required to determine when such deviations justify escalation to second-level diagnostic investigations, including computed tomography or invasive procedures, and when continued observation is appropriate. Acting too early may lead to unnecessary investigations, whereas delayed recognition of pathological trends may result in missed opportunities for timely intervention. The vast majority of these decisions are based on clinical experience and on studies focusing on static assessments of biomarkers at specific time points. However, there is a lack of studies evaluating the dynamic trends of these markers over the postoperative period and providing objective measures to guide clinical decision-making. The DYNAMIC-GI study is a snapshot study designed to evaluate how the temporal trends of routinely collected clinical and laboratory markers are associated with the development of postoperative complications after elective or urgent GI surgery. It aims to provide solid, objective evidence on the timing, magnitude, and comprehensive evaluation of postoperative markers to improve early risk stratification and inform clinical decision-making in the postoperative setting. Additionally, the study will explore whether specific postoperative inflammatory trajectories may facilitate more rational antimicrobial management, including the safe de-escalation of antibiotic therapy in patients without evidence of evolving postoperative complications.
Trial Details
NCT Number NCT07509710
Lead Sponsor Azienda Ospedaliero Universitaria Maggiore della Carita
Collaborators: Mario Negri Institute for Pharmacological Research, University of Cagliari, Federico II University
Conditions
(from sponsor)
Oncologic Disease, Urgent Surgery
Related terms Postoperative Complications
Enrollment 1,500 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov