About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
The patient is scheduled to undergo a major resection-type abdominal surgery due to cancer of the esophagus, stomach, pancreas, liver, bile ducts, colon or rectum.
Patient is willing to participate.
Age ≥ 18 years.
Disqualifiers
Pregnancy.
Previous surgical resection of the digestive tract, excluding appendectomy and/or cholecystectomy.
Anticipated operation with preventive ileostomy.
The operation is planned to be performed as a matter of urgency.
Trial population
Patients scheduled to undergo major abdominal surgery due to the cancer of the esophagus, stomach, pancreas, liver, bile ducts, colon, or rectum due to cancer will be eligible to participate.
Trial design
Cohort
Prospective
Treatments tested in this trial
Major visceral surgery for gastrointestinal cancer
Procedure/SurgeryThis is a longitudinal observational study of the patients undergoing major visceral surgery for gastrointestinal cancer. Biological samples will be collected to compare gastrointestinal and infection site metastases and develop biomarkers for postoperative infections.
Treatment groups
Trial outcomes
Primary outcomes
The similarity in composition between the infection site microbiome and the gut/oral microbiome.
Secondary outcomes
Incidence of postoperative infections after major abdominal surgery for gastrointestinal cancer.
Infections diagnosed within 30 days after surgery
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.
Major abdominal resection impact on gut microbiome composition.
Baseline and POD6 gut microbiome composition will be compared.
Gut microbiome-based biomarkers for postoperative infections.
Sponsors and contacts
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National Cancer Center Affiliate of Vilnius University Hospital Santaros Klinikos
Lead sponsor
Vilnius University Hospital Santaros Klinikos
Collaborator