Clinical trial · Observational
Pathogenesis of Postoperative Infections and Biomarkers for Early Diagnosis of it
New Studies of the Pathogenesis of Postoperative Infections and Development of Biomarkers for Early Diagnosis of Postoperative Complications
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Complication of Surgical Procedure | — | UNRESOLVED | — |
| Infections | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Major visceral surgery for gastrointestinal cancer | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- The similarity in composition between the infection site microbiome and the gut/oral microbiome.
- timeFrame
- 0 to 30 days
Secondary outcomes (7)
- measure
- Incidence of postoperative infections after major abdominal surgery for gastrointestinal cancer.
- timeFrame
- 0 to 30 days
- description
- Infections diagnosed within 30 days after surgery
- measure
- Incidence of surgical site infections after major abdominal surgery for gastrointestinal cancer.
- timeFrame
- 0 to 30 days
- description
- A surgical site infection (SSI) is an infection in the part of the body where a surgery took place.
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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).
References
Publications (0)
Data not yet available