NCT06513598 Pathogenesis of Postoperative Infections and Biomarkers for Early Diagnosis of it
| NCT ID | NCT06513598 |
| Status | Recruiting |
| Phase | — |
| Sponsor | National Cancer Center Affiliate of Vilnius University Hospital Santaros Klinikos |
| Condition | Complication of Surgical Procedure |
| Study Type | OBSERVATIONAL |
| Enrollment | 200 participants |
| Start Date | 2024-07-01 |
| Primary Completion | 2025-05-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 200 participants in total. It began in 2024-07-01 with a primary completion date of 2025-05-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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).
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06513598 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Complication of Surgical Procedure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06513598 currently recruiting?
Yes, NCT06513598 is actively recruiting participants. Contact the research team at augustinas.bausys@nvi.lt for enrollment information.
Where is the NCT06513598 trial being conducted?
This trial is being conducted at Vilnius, Lithuania, Vilnius, Lithuania.
Who is sponsoring the NCT06513598 clinical trial?
NCT06513598 is sponsored by National Cancer Center Affiliate of Vilnius University Hospital Santaros Klinikos. The trial plans to enroll 200 participants.