Pathogenesis of Postoperative Infections and Biomarkers for Early Diagnosis of it
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Major visceral surgery for gastrointestinal cancer.
- Who it may be relevant to
- Registry conditions: Complication of Surgical Procedure, Infections. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Lithuania
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
New Studies of the Pathogenesis of Postoperative Infections and Development of Biomarkers for Early Diagnosis of Postoperative Complications
Overview
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.
Detailed description
Infections remain a significant concern following major abdominal surgery. The prevailing notion that most surgical site infections (SSIs) after elective surgery with modern antiseptic techniques are solely caused by intraoperative contamination remains unconfirmed. Therefore, alternative mechanisms for SSI development, such as the Trojan Horse theory-which suggests that pathogens from distant sites like the gastrointestinal tract may contribute to postoperative infections-require thorough investigation. This longitudinal observational study aims to either support or challenge the Trojan Horse theory.
This study will enroll patients undergoing major abdominal surgery for confirmed or suspected cancer. Biological samples from stool, the oral cavity, and infection sites will be collected for sequencing and microbiome analysis to evaluate the presence of pathogens potentially responsible for postoperative infections originating from the gastrointestinal tract. Additionally, blood samples will be collected to identify predictive biomarkers associated with the development of postoperative infections.
Interventions
- Procedure Major 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.
Primary outcome measures
- The similarity in composition between the infection site microbiome and the gut/oral microbiome. [Time frame: 0 to 30 days]
Secondary outcome measures (7)
- Incidence of postoperative infections after major abdominal surgery for gastrointestinal cancer. [Time frame: 0 to 30 days]
- Incidence of surgical site infections after major abdominal surgery for gastrointestinal cancer. [Time frame: 0 to 30 days]
- Major abdominal resection impact on gut microbiome composition. [Time frame: 0 to 30 days]
- Gut microbiome-based biomarkers for postoperative infections. [Time frame: 0 to 30 days]
- Intestinal wall permeability and local inflammatory markers (LBP, I-FABP, sCD14, etc.) will be evaluated as a potential biomarkers for postoperative infections. [Time frame: 0 to 30 days]
- Inflammatory cytokines (IL4; IL2; IP10; IL1β; TNFα; etc.) and pro-inflamatory microRNAs (miRNA-21, miRNA-155, etc.) will be evaluated as a potential biomarkers for postoperative infections. [Time frame: 0 to 30 days]
- The proportion of patients developing wound infections among those with positive and negative wound cultures at the conclusion of surgery. [Time frame: 0 to 30 days]
Eligibility criteria
Inclusion criteria
- 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 criteria
- 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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
Lithuania · 2 centers
- National Cancer Institute — Vilnius
- Vilnius University hospital Santaros Klinikos — Vilnius
Identifiers
NCT: NCT06513598 · 1v3