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Pathogenesis of Postoperative Infections and Biomarkers for Early Diagnosis of it

Recruitingn/aAges 18 Years - anyAllNational Cancer Center Affiliate of Vilnius Unive…
NCT06513598 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. 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. 2. Patient is willing to participate. 3. Age ≥ 18 years. Exclusion Criteria: 1. Pregnancy. 2. Previous surgical resection of the digestive tract, excluding appendectomy and/or cholecystectomy. 3. Anticipated operation with preventive ileostomy. 4. The operation is planned to be performed as a matter of urgency. 5. Antibiotic therapy ≤1 month. before surgery. 6. Chronic inflammatory bowel disease (non-specific ulcerative colitis, Crohn's disease) or radiation or other colitis of origin. 7. During the last year, the patient suffered from Cl. difficile colitis or was Cl. difficile carrier, had salmonellosis or others intestinal infections. 8. During the last year, the patient used (\> 3 months) pre-/pro-/(syn)biotics. 9. During the last year, the patient has been taking proton pump inhibitors continuously (\> 6 months).
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What it tests

  • Major visceral surgery for gastrointestinal cancer
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Where

2 sites
National Cancer Institute
Vilnius, Lithuania
Vilnius University hospital Santaros Klinikos
Vilnius, Lithuania
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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