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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New Studies of the Pathogenesis of Postoperative Infections and Development of Biomarkers for Early Diagnosis of Postoperative Complications
- ClinicalTrials.gov ID
- NCT06513598
- Acronym / sponsor ID
- 1v3
- Conditions
- Complication of Surgical Procedure, Infections
- Keywords
- microbiota, surgical oncology, gastrointestinal cancer, postoperative complications, biomarkers
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- National Cancer Center Affiliate of Vilnius University Hospital Santaros KlinikosUniversity, hospital or other
- Collaborators
- Vilnius University Hospital Santaros Klinikos
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 30 May 2025 (estimated)
- Study completion
- 1 May 2029 (estimated)
- First posted
- 22 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Major visceral surgery for gastrointestinal cancerThis 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. | Procedure or surgery | – |
Primary outcome
The similarity in composition between the infection site microbiome and the gut/oral microbiome.
Time frame: 0 to 30 days
7 secondary outcomes
Incidence of postoperative infections after major abdominal surgery for gastrointestinal cancer.
Time frame: 0 to 30 days
Incidence of surgical site infections after major abdominal surgery for gastrointestinal cancer.
Time frame: 0 to 30 days
Major abdominal resection impact on gut microbiome composition.
Time frame: 0 to 30 days
Gut microbiome-based biomarkers for postoperative infections.
Time frame: 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.
Time frame: 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.
Time frame: 0 to 30 days
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Lithuania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Augustinas Bausys (37062214027, augustinas.bausys@nvi.lt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The similarity in composition between the infection site microbiome and the gut/oral microbiome. (time frame: 0 to 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2024.