Bacteria and Intestinal Translocation in Surgery (Bandit)
Condition(s) studied
Investigational drug(s) / intervention(s)
No intervention: This is purely an observational study. Groups SSI/No SSI are defined by the occurence of a surgical site infection.
Study 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.
Eligibility
Primary outcome measure(s)
- Detection of bacterial DNA in liver biopsy — day 0 (operation day)
Rationale: One of the aims is to test how the liver acts as primary barrier for blood-borne bacteria during the operation. Sampling: During elective abdominal surgery a biopsy with the Tru-Cut™ Needle (Baxter healthcare Co., 16G Chicago, USA) is performed as recommended by the manufacturer. Hemostasis is achieved by Application of mono-polar Electrocautery. Processing: The sample is immediately snap-frozen in liquid nitrogen. Storage: Biobank: -80°C. Analysis: Polymerase chain reaction (PCR) with bacteria specific primers, Sequencing of the PCR product (IonTorrent) to determine the present microbiota (species if possible, at least families). The difference in positive/negative liver probes is compared for patients with and without surgical site infections (Chi squared Test).
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Inselspital, University Hospital Bern, Visceral Surgery Department | Bern | Switzerland |
More Insel Gruppe AG, University Hospital Bern trials in Switzerland
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT03554148 on ClinicalTrials.gov ↗ ← All trials in Switzerland