Pathogenesis of Postoperative Infections and Biomarkers for Early Diagnosis of it

NCT06513598 | Recruiting

• 1 other identifier: 1v3
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Complication of Surgical Procedure; Infections

Keywords

microbiota; surgical oncology; gastrointestinal cancer; postoperative complications; biomarkers

Outcome Measures

Primary Outcomes (1)

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

  0 to 30 days

Secondary Outcomes (7)

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

  0 to 30 days

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

  0 to 30 days

• Major abdominal resection impact on gut microbiome composition.

  0 to 30 days

• Gut microbiome-based biomarkers for postoperative infections.

  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.

  0 to 30 days

Interventions

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• National Cancer Center Affiliate of Vilnius University Hospital Santaros Klinikos: lead
• Vilnius University Hospital Santaros Klinikos: collaborator

Study Sites (2)

National Cancer Institute

Vilnius, Lithuania

RECRUITING

Vilnius University hospital Santaros Klinikos

Vilnius, Lithuania

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

1\) Stool samples; 2) oral cavity swabs; 3) blood 4) samples from infection sites

MeSH Terms

Conditions

Infections; Gastrointestinal Neoplasms; Postoperative Complications

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Augustinas Bausys

CONTACT

37062214027; augustinas.bausys@nvi.lt

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 17, 2024
• First Posted: July 22, 2024
• Study Start: July 1, 2024
• Primary Completion: May 30, 2025
• Study Completion (Estimated): May 1, 2029
• Last Updated: August 1, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

LI (2)