Pathogenesis of Postoperative Infections and Biomarkers for Early Diagnosis of it

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorNational Cancer Center Affiliate of Vilnius University Hospital Santaros Klinikos

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial population

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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Major visceral surgery for gastrointestinal cancer

    Procedure/Surgery

    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.

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

The similarity in composition between the infection site microbiome and the gut/oral microbiome.

Time frame
0 to 30 days

Secondary outcomes

1

Incidence of postoperative infections after major abdominal surgery for gastrointestinal cancer.

Infections diagnosed within 30 days after surgery

Time frame
0 to 30 days
2

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
3

Major abdominal resection impact on gut microbiome composition.

Baseline and POD6 gut microbiome composition will be compared.

Time frame
0 to 30 days
4

Gut microbiome-based biomarkers for postoperative infections.

Time frame
0 to 30 days

Other outcomes

Sponsors and contacts

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