Investigating bacteria and intestinal translocation in patients undergoing abdominal surgery
Assessment of Bacterial Translocation on the Incidence of Surgical Site Infection in Abdominal Surgery: Prospective Cohort Study.
This study is testing how bacteria in the body might affect the risk of infections in patients having elective abdominal surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 209 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Insel Gruppe AG, University Hospital Bern Academic / other |
| Locations | 1 site (Bern) |
| Trial ID | NCT03554148 on ClinicalTrials.gov |
What this trial studies
This observational study aims to analyze the relationship between bacteria and surgical site infections in patients undergoing elective abdominal surgery. Participants will provide baseline health data and microbiota samples before surgery, and additional samples will be collected during the procedure. The study will utilize 16sRNA sequencing to quantify bacterial species in various samples, comparing those who develop surgical site infections to those who do not. The primary outcome is to assess differences in bacterial signals in liver and lymph node biopsies between these two groups.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 years old who are scheduled for elective abdominal surgery and can provide informed consent.
Not a fit: Patients who are pregnant, have known multi-resistant bacterial colonization, or have cirrhotic liver disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of bacterial involvement in surgical site infections, potentially leading to improved prevention strategies.
How similar studies have performed: While the approach of using 16sRNA sequencing in this context is innovative, similar studies have shown promise in understanding the microbiota's role in surgical outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Informed Consent * All Ages * All Gender * Elective Abdominal Surgery * Age \> 18 * All approached (laparoscopic, open) * All ethnic and sociodemographic backgrounds * Sufficient knowledge of the study language (German) Exclusion Criteria: * pregnant or lactating women * no operation performed (i.e. only planned) * insufficient knowledge of project language (German) * lack of informed consent * known colonization with multi-resistant bacteria (e.g. Methicillin-resistant Staphylococcus aureus (MRSA) or extended spectrum betalactamase (ESBL)) * known cirrhotic liver disease
Where this trial is running
Bern
- Inselspital, University Hospital Bern, Visceral Surgery Department — Bern, Switzerland (Recruiting)
Study contacts
- Study coordinator: Guido Beldi, MD, Prof
- Email: guido.beldi@insel.ch
- Phone: 031 632 21 11
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.