Official Title
Assessment of Bacterial Translocation on the Incidence of Surgical Site Infection in Abdominal Surgery: Prospective Cohort Study.
Brief Title
Bacteria and Intestinal Translocation in Surgery (Bandit)
Protocol ID
NCT03554148
Lead Sponsor
Insel Gruppe AG, University Hospital Bern
Brief Summary
Patients undergoing elective abdominal surgery will be included prospectively. Informed
consent will be obtained. Preoperatively baseline health data is collected and a skin
swab and rectal swab for baseline skin and gut microbiota is taken. During the surgery
additional clinical data and additional samples will be obtained. Additional samples
include: rectal swab, biopsies of the resected specimen (lymph node, peritoneum,
intestinal content, mucosa), venous blood sample (7.5ml) at the end of the operation,
liver biopsy and skin biopsy. Postoperative health data is recorded. If a surgical site
infection occurs a swab is taken too. With 16 sRNA (small ribonucleic acid) based
sequencing the investigators will quantify the abundance of the different bacterial
species in all samples. Primary outcome will be to assess a difference of 16sRNA signal
in the liver and lymph node biopsies between patients with and patients without surgical
site infection. Secondary outcomes include variables predicting the occurence of surgical
site infections and a model describing the way bacteria may take to cause wound
infection.
Study Period
-
Enrollment Count
209 participants
Eligibility 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
Filters
Surgical Site Infection
UNKNOWN
ADULT
OLDER_ADULT