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NCT Number: NCT06513598

Pathogenesis of Postoperative Infections and Biomarkers for Early Diagnosis of it

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

National Cancer Institute, Vilnius, Lithuania

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Major visceral surgery for gastrointestinal cancer

Procedure

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 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.

    Time frame: 0 to 30 days

    Infections diagnosed within 30 days after surgery

  2. Incidence of surgical site infections after major abdominal surgery for gastrointestinal cancer.

    Time frame: 0 to 30 days

    A surgical site infection (SSI) is an infection in the part of the body where a surgery took place.

  3. Major abdominal resection impact on gut microbiome composition.

    Time frame: 0 to 30 days

    Baseline and POD6 gut microbiome composition will be compared.

  4. Gut microbiome-based biomarkers for postoperative infections.

    Time frame: 0 to 30 days

  5. 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

    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.

  6. 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

    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.

  7. 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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Augustinas Bausys

CONTACT

[email protected]

37062214027

Sponsors and collaborators

Lead sponsor

National Cancer Center Affiliate of Vilnius University Hospital Santaros Klinikos

Other

Collaborators

  • Vilnius University Hospital Santaros Klinikos

Registry information

Official study title

New Studies of the Pathogenesis of Postoperative Infections and Development of Biomarkers for Early Diagnosis of Postoperative Complications

Important dates

Study start
2024
Primary completion
2025
Study completion
2029
First posted
Jul 22, 2024
Registry last updated
Aug 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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