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.
Age ≥ 18 years
Elective or urgent major GI surgery
Availability of postoperative clinical data and at least three postoperative measurements of inflammatory markers to allow identification of trajectory patterns
Procedures without postoperative monitoring
Death within 24 hours of surgery
Absence of key postoperative clinical or laboratory data
Eligible procedures will include major elective or urgent GI surgery, under general anaesthesia, at higher risk of early post-operative complications, involving: * Upper GI tract (oesophagus, stomach, duodenum) * Hepato-pancreato-biliary surgery * Small bowel and colorectal surgery Surgical procedure under local anaesthesia, including soft tissues, proctological intervention, abdominal wall, hiatal repair, exploring laparotomy or adhesiolisis in absence of bowel resection will not be considered for inclusion.
Cohort
Prospective
blood sampling
Diagnostic testPostoperative follow-up with physiological and biochemical parameters
Postoperative infective complications
Occurrence of postoperative infective complications within 90 days, defined as any infective complication requiring surgical, endoscopic, or radiological intervention or resulting in life-threatening organ dysfunction (i.e., Clavien-Dindo classification grade \> III). The Clavien-Dindo classification ranges from grade I (minor deviation from normal postoperative course) to grade V (death), with higher grades indicating more severe complications.
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Azienda Ospedaliero Universitaria Maggiore della Carita
Lead sponsor
Mario Negri Institute for Pharmacological Research
Collaborator
University of Cagliari
Collaborator
Federico II University
Collaborator
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