Pathogenesis of Postoperative Infections and Biomarkers for Early Diagnosis of it

NCT ID: NCT06513598

Last Updated: 2024-08-01

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-07-01
• Study Completion Date: 2029-05-01

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.

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.

Conditions

Complication of Surgical Procedure; Infections

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. 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.

2. Patient is willing to participate.

3. Age ≥ 18 years.

Exclusion Criteria

1. Pregnancy.

2. Previous surgical resection of the digestive tract, excluding appendectomy and/or cholecystectomy.

3. Anticipated operation with preventive ileostomy.

4. The operation is planned to be performed as a matter of urgency.

5. Antibiotic therapy ≤1 month. before surgery.

6. Chronic inflammatory bowel disease (non-specific ulcerative colitis, Crohn's disease) or radiation or other colitis of origin.

7. During the last year, the patient suffered from Cl. difficile colitis or was Cl. difficile carrier, had salmonellosis or others intestinal infections.

8. During the last year, the patient used (> 3 months) pre-/pro-/(syn)biotics.

9. During the last year, the patient has been taking proton pump inhibitors continuously (> 6 months).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Vilnius University Hospital Santaros Klinikos

OTHER

Sponsor Role: collaborator

National Cancer Center Affiliate of Vilnius University Hospital Santaros Klinikos

OTHER

Sponsor Role: lead

Responsible Party

Augustinas Bausys

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

National Cancer Institute

Vilnius, , Lithuania

Site Status: RECRUITING

Vilnius University hospital Santaros Klinikos

Vilnius, , Lithuania

Site Status: RECRUITING

Countries

Lithuania

Central Contacts

Augustinas Bausys

Role: CONTACT

augustinas.bausys@nvi.lt

37062214027

Facility Contacts

Augustinas Baušys, MD, PhD

Role: primary

augustinas.bausys@nvi.lt

+37062363865

Marius Kryzauskas, MD, PhD

Role: primary

marius.kryzauskas@santa.lt

+37062214027

Other Identifiers

1v3

Identifier Type: -

Identifier Source: org_study_id