An observational study in Complication of Surgical Procedure and Infections, sponsored by National Cancer Center Affiliate of Vilnius University Hospital Santaros Klinikos. Recruiting at 2 sites in Lithuania. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-01.
Sponsored by National Cancer Center Affiliate of Vilnius University Hospital Santaros Klinikos · Observational
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.
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.
6,702 studies on the registry are indexed under Infections; 801 are open to participants now.
This study's planned enrollment of 200 is below the median of 240 across 2,144 observational studies indexed under Infections.
Browse Infections studies →National Cancer Center Affiliate of Vilnius University Hospital Santaros Klinikos is the lead sponsor of 9 studies on the registry; 5 are open to participants now.
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Patients scheduled to undergo major abdominal surgery due to the cancer of the esophagus, stomach, pancreas, liver, bile ducts, colon, or rectum due to cancer will be eligible to participate.
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Exclusion Criteria:
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.
The similarity in composition between the infection site microbiome and the gut/oral microbiome.
Time frame: 0 to 30 days
Incidence of postoperative infections after major abdominal surgery for gastrointestinal cancer.
Infections diagnosed within 30 days after surgery
Time frame: 0 to 30 days
Incidence of surgical site infections after major abdominal surgery for gastrointestinal cancer.
A surgical site infection (SSI) is an infection in the part of the body where a surgery took place.
Time frame: 0 to 30 days
Major abdominal resection impact on gut microbiome composition.
Baseline and POD6 gut microbiome composition will be compared.
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.
Intestinal wall permeability and local inflammatory markers (LBP, I-FABP, sCD14, etc.) on PODs2, 3 and 4 will be evaluated as 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.
Inflammatory cytokines (IL4; IL2; IP10; IL1β; TNFα; etc.) and pro-inflamatory microRNAs (miRNA-21, miRNA-155, etc.) on PODs2, 3 and 4 will be evaluated as 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.
Wound swabs will be taken for culture at the end of surgery before closing skin. Proportion of patients developing wound infection among patients with positive and negative culture will be determined.
Time frame: 0 to 30 days
Plan to share: No
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National Cancer Center Affiliate of Vilnius University Hospital Santaros Klinikos