Complication of Surgical ProcedureNCT06513598
Pathogenesis of Postoperative Infections and Biomarkers for Early Diagnosis of it
An observational study of Complication of Surgical Procedure and Infections, run by National Cancer Center Affiliate of Vilnius University Hospital Santaros Klinikos at 2 sites in Lithuania.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Complication of Surgical Procedure, Infections
- What is being tested?
- Major visceral surgery for gastrointestinal cancer
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 2 sitesLithuania
- Study dates
- 1 Jul 2024to 1 May 2029
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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).
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Lithuania2 sites, 2 recruiting
- Recruiting
National Cancer Institute
Vilnius
Augustinas Baušys, MD, PhD, +37062363865, augustinas.bausys@nvi.lt
- Recruiting
Vilnius University hospital Santaros Klinikos
Vilnius
Marius Kryzauskas, MD, PhD, +37062214027, marius.kryzauskas@santa.lt
About this study
Official title: New Studies of the Pathogenesis of Postoperative Infections and Development of Biomarkers for Early Diagnosis of Postoperative Complications
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.
Read the 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
- Being tested
- Major visceral surgery for gastrointestinal cancer
- Keywords
- microbiota, surgical oncology, gastrointestinal cancer, postoperative complications, biomarkers
- Medical subject headings
- Infections, Gastrointestinal Neoplasms, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Major visceral surgery for gastrointestinal cancerProcedure or 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
The similarity in composition between the infection site microbiome and the gut/oral microbiome.
Measured: 0 to 30 days
Secondary outcomes (7)
Incidence of postoperative infections after major abdominal surgery for gastrointestinal cancer.
Infections diagnosed within 30 days after surgery
Measured: 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.
Measured: 0 to 30 days
Major abdominal resection impact on gut microbiome composition.
Baseline and POD6 gut microbiome composition will be compared.
Measured: 0 to 30 days
Gut microbiome-based biomarkers for postoperative infections.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 0 to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2024
- Study start1 Jul 2024
- Primary completion30 May 2025 (estimated)
- Study completion1 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complication of Surgical ProcedureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Center Affiliate of Vilnius University Hospital Santaros Klinikos
- Sponsor type
- University, hospital or other
- Collaborators
- Vilnius University Hospital Santaros Klinikos
- Responsible party
- Principal investigator, Augustinas Bausys, National Cancer Center Affiliate of Vilnius University Hospital Santaros Klinikos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06513598
- Sponsor's protocol ID
- 1v3
- Status last verified
- Jul 2024
- First submitted
- 17 Jul 2024
- Last updated
- 1 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No