Dynamic Postoperative Trends for Early Detection of Complications After Gastrointestinal Surgery

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAzienda Ospedaliero Universitaria Maggiore della Carita

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

Procedures without postoperative monitoring

Death within 24 hours of surgery

Absence of key postoperative clinical or laboratory data

Trial design

Treatments tested in this trial

  • blood sampling

Treatment groups

1,500 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators

Azienda Ospedaliero Universitaria Maggiore della Carita

Lead sponsor

Mario Negri Institute for Pharmacological Research

Collaborator

University of Cagliari

Collaborator

Federico II University

Collaborator