RecruitingNCT06513598

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

Sponsor

National Cancer Center Affiliate of Vilnius University Hospital Santaros Klinikos

Enrollment

200 participants

Start Date

Jul 1, 2024

Study Type

OBSERVATIONAL

Conditions

Complication of Surgical Procedure Infections

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

Min Age: 18 Years

Inclusion Criteria3

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.

Exclusion Criteria9

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).

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Interventions

PROCEDUREMajor visceral surgery for gastrointestinal cancer

This is a longitudinal observational study of the patients undergoing major visceral surgery for gastrointestinal cancer. Biological samples will be collected to compare gastrointestinal and infection site metastases and develop biomarkers for postoperative infections.