Pathogenesis of Postoperative Infections and Biomarkers for Early Diagnosis of it
NCT Number: NCT06513598
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Complication of Surgical Procedure|Infections
Interventions: PROCEDURE: Major visceral surgery for gastrointestinal cancer
Sponsor: National Cancer Institute, Lithuania
Collaborators: Vilnius University Hospital Santaros Klinikos
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 200
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-01
Completion Date: 2029-05-01
Locations: National Cancer Institute, Vilnius, Lithuania|Vilnius University hospital Santaros Klinikos, Vilnius, Lithuania

Summary:
Infections remain a prevalent complication after major abdominal surgery. The common belief that most surgical site infections (SSIs) following elective surgery with modern antiseptic techniques are due to intraoperative contamination is still not confirmed. Therefore, alternative mechanisms for SSI development, such as the Trojan Horse theory-which suggests that pathogens from distant sites like the gastrointestinal tract may cause postoperative infections-should be explored. This study aims to analyze the preoperative microbiome of surgical patients' gut and oral cavities and assess whether microorganisms found there are present at the infection site. Additionally, this study will investigate a panel of biomarkers for predicting postoperative infections.

Primary Outcome Measures: The similarity in composition between the infection site microbiome and the gut/oral microbiome., 0 to 30 days
Secondary Outcome Measures: Incidence of postoperative infections after major abdominal surgery for gastrointestinal cancer., Infections diagnosed within 30 days after surgery, 0 to 30 days|Incidence of surgical site infections after major abdominal surgery for gastrointestinal cancer., A surgical site infection (SSI) is an infection in the part of the body where a surgery took place., 0 to 30 days|Major abdominal resection impact on gut microbiome composition., Baseline and POD6 gut microbiome composition will be compared., 0 to 30 days|Gut microbiome-based biomarkers for postoperative infections., 0 to 30 days|Intestinal wall permeability and local inflammatory markers (LBP, I-FABP, sCD14, etc.) will be evaluated as a potential biomarkers for postoperative infections., Intestinal wall permeability and local inflammatory markers (LBP, I-FABP, sCD14, etc.) on PODs2, 3 and 4 will be evaluated as potential biomarkers for postoperative infections., 0 to 30 days|Inflammatory cytokines (IL4; IL2; IP10; IL1β; TNFα; etc.) and pro-inflamatory microRNAs (miRNA-21, miRNA-155, etc.) will be evaluated as a potential biomarkers for postoperative infections., Inflammatory cytokines (IL4; IL2; IP10; IL1β; TNFα; etc.) and pro-inflamatory microRNAs (miRNA-21, miRNA-155, etc.) on PODs2, 3 and 4 will be evaluated as potential biomarkers for postoperative infections., 0 to 30 days|The proportion of patients developing wound infections among those with positive and negative wound cultures at the conclusion of surgery., Wound swabs will be taken for culture at the end of surgery before closing skin. Proportion of patients developing wound infection among patients with positive and negative culture will be determined., 0 to 30 days