Investigating causes and early detection of infections after major abdominal surgery
New Studies of the Pathogenesis of Postoperative Infections and Development of Biomarkers for Early Diagnosis of Postoperative Complications
This study is trying to find out if germs from the gut and mouth can cause infections after major abdominal surgery in cancer patients, and if certain biological markers can help predict these infections.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | National Cancer Center Affiliate of Vilnius University Hospital Santaros Klinikos Academic / other |
| Drugs / interventions | radiation |
| Locations | 2 sites (Vilnius and 1 other locations) |
| Trial ID | NCT06513598 on ClinicalTrials.gov |
What this trial studies
This observational study aims to explore the mechanisms behind postoperative infections following major abdominal surgeries, particularly in cancer patients. It will analyze the preoperative microbiome from patients' gut and oral cavities to determine if pathogens from these areas contribute to surgical site infections. Additionally, the study will collect biological samples to identify biomarkers that may predict the likelihood of developing infections post-surgery. By challenging the traditional understanding of infection sources, this research seeks to provide new insights into infection prevention.
Who should consider this trial
Good fit: Ideal candidates are adults scheduled for major abdominal surgery due to confirmed or suspected gastrointestinal cancer.
Not a fit: Patients who have had previous surgical resections of the digestive tract or those with certain gastrointestinal infections or conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved strategies for preventing postoperative infections, enhancing patient outcomes after major surgeries.
How similar studies have performed: While the approach of investigating the microbiome in relation to postoperative infections is gaining interest, this specific study's focus on the Trojan Horse theory is relatively novel and has not been extensively tested in prior research.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Vilnius and 1 other locations
- National Cancer Institute — Vilnius, Lithuania (Recruiting)
- Vilnius University hospital Santaros Klinikos — Vilnius, Lithuania (Recruiting)
Study contacts
- Study coordinator: Augustinas Bausys
- Email: augustinas.bausys@nvi.lt
- Phone: 37062214027
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.