Pathogenesis of Postoperative Infections and Biomarkers for Early Diagnosis of it
Recruiting now
Conditions studied: Complication of Surgical Procedure, Infections
In brief
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.
Key facts
- Study ID
- NCT06513598
- Run by
- National Cancer Center Affiliate of Vilnius University Hospital Santaros Klinikos
- People needed
- 200
- Starts
- 2024-07-01
- Expected to finish
- 2029-05-01
- Last updated by the study team
- 2024-08-01
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
- Antibiotic therapy ≤1 month. before surgery.
- Chronic inflammatory bowel disease (non-specific ulcerative colitis, Crohn's disease) or radiation or other colitis of origin.
- During the last year, the patient suffered from Cl. difficile colitis or was Cl. difficile carrier, had salmonellosis or others intestinal infections.
- During the last year, the patient used (> 3 months) pre-/pro-/(syn)biotics.
- During the last year, the patient has been taking proton pump inhibitors continuously (> 6 months).
Where it is running
- National Cancer Institute — Vilnius, Lithuania (enrolling)
- Vilnius University hospital Santaros Klinikos — Vilnius, Lithuania (enrolling)
Full record on ClinicalTrials.gov
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